Trial Outcomes & Findings for ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff (NCT NCT04899245)

NCT ID: NCT04899245

Last Updated: 2024-07-17

Results Overview

Feasibility of school based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log. Two data limitations to note: * The enrollment rate was not stratified by caregiver and child number at the time of data collection. The data was collected at the level of the child. * The enrollment rate was not stratified by caregiver/child dyad and staff at the time of data collection. This is a limitation of our data. It is not possible to stratify this outcome and it is therefore analyzed together.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

Study duration (up to 21 months)

Results posted on

2024-07-17

Participant Flow

The protocol enrollment, started, and completed values reflect caregiver/child dyads. There were n = 41 caregivers, n = 47 children.

Participant milestones

Participant milestones
Measure
Parent/Caregiver of Children With Medical Complexity (CMC)
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Child With Medical Complexity
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Overall Study
STARTED
41
47
24
Overall Study
COMPLETED
17
19
21
Overall Study
NOT COMPLETED
24
28
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Parent/Caregiver of Children With Medical Complexity (CMC)
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Child With Medical Complexity
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Overall Study
Withdrawal by Subject
3
5
2
Overall Study
No longer eligible - Left staff position
0
0
1
Overall Study
No longer eligible - Child graduated from school program
19
21
0
Overall Study
No longer eligible - Moved away from area
2
2
0

Baseline Characteristics

ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
School Staff
n=24 Participants
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Children With Medical Complexity (CMC)
n=47 Participants
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Parent/Caregiver With Children With Medical Complexity (CMC)
n=41 Participants
65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Total
n=112 Participants
Total of all reporting groups
Sex/Gender, Customized
Sex · Male
1 Participants
n=5 Participants
22 Participants
n=7 Participants
9 Participants
n=5 Participants
32 Participants
n=4 Participants
Sex/Gender, Customized
Sex · Not reported
0 Participants
n=5 Participants
5 Participants
n=7 Participants
1 Participants
n=5 Participants
6 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
4 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=5 Participants
39 Participants
n=7 Participants
39 Participants
n=5 Participants
102 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
4 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
9 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
White
20 Participants
n=5 Participants
32 Participants
n=7 Participants
32 Participants
n=5 Participants
84 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
5 Participants
n=7 Participants
1 Participants
n=5 Participants
6 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
5 Participants
n=7 Participants
2 Participants
n=5 Participants
7 Participants
n=4 Participants
Region of Enrollment
United States
24 participants
n=5 Participants
47 participants
n=7 Participants
41 participants
n=5 Participants
112 participants
n=4 Participants
Age, Continuous
40 years
n=5 Participants
3 years
n=7 Participants
36 years
n=5 Participants
NA years
n=4 Participants
Sex/Gender, Customized
Sex · Female
23 Participants
n=5 Participants
20 Participants
n=7 Participants
31 Participants
n=5 Participants
74 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Population: The number analyzed must include those who were approached and not consented in addition to those consented.

Feasibility of school based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log. Two data limitations to note: * The enrollment rate was not stratified by caregiver and child number at the time of data collection. The data was collected at the level of the child. * The enrollment rate was not stratified by caregiver/child dyad and staff at the time of data collection. This is a limitation of our data. It is not possible to stratify this outcome and it is therefore analyzed together.

Outcome measures

Outcome measures
Measure
Staff and Children
n=88 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached
Number approached, enrolled
71 Participants
Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached
Number approached, not enrolled
17 Participants

PRIMARY outcome

Timeframe: Every week up to 21 months

* Tests expected: Children and staff in this study will have nasal swab testing performed at school twice weekly (as well as anytime they have symptoms) for the first 3 months of the study. After 3 months, the twice-weekly testing may decrease to symptom-only testing if the rate of COVID spread decreases in Wisconsin. Symptom-only testing is not included as an "expected" test. * The number of tests expected was assessed specifically for this outcome measure to determine if testing was proceeding as expected. This value was based on the number of children and staff enrolled at a given time, whether surveillance or symptom-only testing was being conducted, and if any of the participants had COVID-19 (excluding them from testing). This value was not created at baseline, but was dynamic over the course of the study dependent upon the aforementioned factors. * The tests expected value was not stratified by child and staff at the time of data collection. It is a limitation of the data.

Outcome measures

Outcome measures
Measure
Staff and Children
n=2368 BinaxNOW Rapid Antigen COVID-19 Tests
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in COVID Test Rate at School: Number of Total Child and Staff Tests Completed as Compared to Number of Tests Expected
Number of tests completed
2368 BinaxNow Rapid Antigen COVID-19 Tests
Change in COVID Test Rate at School: Number of Total Child and Staff Tests Completed as Compared to Number of Tests Expected
Number of tests expected
2688 BinaxNow Rapid Antigen COVID-19 Tests

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be retrieved from study log.

Outcome measures

Outcome measures
Measure
Staff and Children
n=1403 BinaxNOW Rapid Antigen COVID-19 Tests
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
n=965 BinaxNOW Rapid Antigen COVID-19 Tests
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
195 Symptomatic BinaxNow Rapid Antigen Tests
39 Symptomatic BinaxNow Rapid Antigen Tests

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be retrieved from study log.

Outcome measures

Outcome measures
Measure
Staff and Children
n=1403 BinaxNOW Rapid Antigen COVID-19 Tests
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
n=965 BinaxNOW Rapid Antigen COVID-19 Tests
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed
30 Positive BinaxNOW Rapid Antigen Tests
5 Positive BinaxNOW Rapid Antigen Tests

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be retrieved from study log. All children and staff (n = 71) were included in this outcome. However, participants were not required to and were sometimes unable to complete a confirmatory PCR test after a positive in-home rapid test. This explains the difference between the number of positive at-home COVID-19 tests and the number of PCR tests. Some participants completed multiple confirmatory PCR tests over the study time frame. This explains why the PCR quantity is greater than the number of participants.

Outcome measures

Outcome measures
Measure
Staff and Children
n=49 COVID-19 PCR Tests
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
n=15 COVID-19 PCR Tests
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing
22 Negative confirmatory PCRs
1 Negative confirmatory PCRs

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

* "How many of the people who interact with your child at school have been fully vaccinated?" * Response options: "None", "A few", "Some" "Most", "All", "Don't Know" * Dichotomized into: ("Most" or "All") vs. ("None", "A few", "Some", "Don't Know) * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
Baseline · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
21 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
Baseline · "None", "A few", "Some", "Don't Know"
18 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
6 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
15 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
24 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
7 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
3 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
11 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
3 month · "None", "A few", "Some", "Don't Know"
18 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
6 month · "None", "A few", "Some", "Don't Know"
12 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
9 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
9 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
9 month · "None", "A few", "Some", "Don't Know"
9 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
15 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
4 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
15 month · "None", "A few", "Some", "Don't Know"
4 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
18 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
6 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
18 month · "None", "A few", "Some", "Don't Know"
2 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
21 month · "Most" or "All" of the people who interact with their child at school have been fully vaccinated
7 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
21 month · "None", "A few", "Some", "Don't Know"
9 Participants
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
24 month · "None", "A few", "Some", "Don't Know"
3 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

The following question from the Participant's perceived susceptibility survey will be answered dichotomously and presented qualitatively: * How comfortable are you with...the ability of your child's school to take all precautions to stop the spread of COVID-19? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Susceptibility: School Takes Precautions
18 month · "Very" or "Extremely" comfortable
6 Participants
Caregiver Change in Susceptibility: School Takes Precautions
18 month · "Not at all", "A little", or "Somewhat" comfortable
2 Participants
Caregiver Change in Susceptibility: School Takes Precautions
6 month · "Very" or "Extremely" comfortable
19 Participants
Caregiver Change in Susceptibility: School Takes Precautions
6 month · "Not at all", "A little", or "Somewhat" comfortable
8 Participants
Caregiver Change in Susceptibility: School Takes Precautions
9 month · "Very" or "Extremely" comfortable
12 Participants
Caregiver Change in Susceptibility: School Takes Precautions
9 month · "Not at all", "A little", or "Somewhat" comfortable
6 Participants
Caregiver Change in Susceptibility: School Takes Precautions
15 month · "Very" or "Extremely" comfortable
5 Participants
Caregiver Change in Susceptibility: School Takes Precautions
15 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Susceptibility: School Takes Precautions
21 month · "Very" or "Extremely" comfortable
9 Participants
Caregiver Change in Susceptibility: School Takes Precautions
21 month · "Not at all", "A little", or "Somewhat" comfortable
7 Participants
Caregiver Change in Susceptibility: School Takes Precautions
Baseline · "Very" or "Extremely" comfortable
27 Participants
Caregiver Change in Susceptibility: School Takes Precautions
Baseline · "Not at all", "A little", or "Somewhat" comfortable
13 Participants
Caregiver Change in Susceptibility: School Takes Precautions
3 month · "Very" or "Extremely" comfortable
19 Participants
Caregiver Change in Susceptibility: School Takes Precautions
3 month · "Not at all", "A little", or "Somewhat" comfortable
10 Participants
Caregiver Change in Susceptibility: School Takes Precautions
24 month · "Very" or "Extremely" comfortable
8 Participants
Caregiver Change in Susceptibility: School Takes Precautions
24 month · "Not at all", "A little", or "Somewhat" comfortable
2 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Following questions from the Participant's perceived susceptibility survey will be answered dichotomously (agree or disagree) and presented qualitatively. * In your opinion, how likely is your child to get sick with COVID-19 by attending school in-person? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Susceptibility: Likely to Get COVID-19
Baseline · "Very" or "Extremely" likely
6 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
6 month · "Not at all", "A little", or "Somewhat" likely
25 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
Baseline · "Not at all", "A little", or "Somewhat" likely
33 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
3 month · "Very" or "Extremely" likely
5 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
3 month · "Not at all", "A little", or "Somewhat" likely
24 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
6 month · "Very" or "Extremely" likely
3 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
9 month · "Very" or "Extremely" likely
3 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
9 month · "Not at all", "A little", or "Somewhat" likely
15 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
15 month · "Very" or "Extremely" likely
2 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
15 month · "Not at all", "A little", or "Somewhat" likely
6 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
18 month · "Very" or "Extremely" likely
2 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
18 month · "Not at all", "A little", or "Somewhat" likely
6 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
21 month · "Very" or "Extremely" likely
7 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
21 month · "Not at all", "A little", or "Somewhat" likely
9 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
24 month · "Very" or "Extremely" likely
1 Participants
Caregiver Change in Susceptibility: Likely to Get COVID-19
24 month · "Not at all", "A little", or "Somewhat" likely
9 Participants

PRIMARY outcome

Timeframe: 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived severity construct variables will include: * If your child was sick with COVID-19, how likely would...their health be severely affected * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=39 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
21 month · "Very" or "Extremely" likely
0 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
15 month · "Very" or "Extremely" likely
1 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
15 month · "Not at all", "A little", or "Somewhat" likely
7 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
18 month · "Very" or "Extremely" likely
1 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
18 month · "Not at all", "A little", or "Somewhat" likely
7 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
21 month · "Not at all", "A little", or "Somewhat" likely
13 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
24 month · "Very" or "Extremely" likely
0 Participants
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
24 month · "Not at all", "A little", or "Somewhat" likely
10 Participants

PRIMARY outcome

Timeframe: 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived severity construct variables will be: * "If your child was sick with COVID-19, how likely would...their health be permanently reduced" * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=39 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
15 month · "Very" or "Extremely" likely
1 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
21 month · "Very" or "Extremely" likely
0 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
15 month · "Not at all", "A little", or "Somewhat" likely
7 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
18 month · "Very" or "Extremely" likely
1 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
18 month · "Not at all", "A little", or "Somewhat" likely
7 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
21 month · "Not at all", "A little", or "Somewhat" likely
13 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
24 month · "Very" or "Extremely" likely
0 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
24 month · "Not at all", "A little", or "Somewhat" likely
10 Participants

PRIMARY outcome

Timeframe: 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived severity construct variables will be: * "If my child was sick with COVID-19, they would have grave health consequences." * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=39 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
15 month · "Very" or "Extremely" likely
1 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
24 month · "Very" or "Extremely" likely
0 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
24 month · "Not at all", "A little", or "Somewhat" likely
10 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
15 month · "Not at all", "A little", or "Somewhat" likely
7 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
18 month · "Very" or "Extremely" likely
1 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
18 month · "Not at all", "A little", or "Somewhat" likely
7 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
21 month · "Very" or "Extremely" likely
0 Participants
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
21 month · "Not at all", "A little", or "Somewhat" likely
13 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Participants will answer the following survey question in quite a bit / a great deal vs not: * "Based on the situation right now, how much do you want your child to attend school in-person at least some of the time?" * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
6 month · "Somewhat," "A little," or "Not at all"
1 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
15 month · "Somewhat," "A little," or "Not at all"
0 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
Baseline · "Quite a bit" or "A great deal"
30 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
Baseline · "Somewhat," "A little," or "Not at all"
9 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
3 month · "Quite a bit" or "A great deal"
26 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
3 month · "Somewhat," "A little," or "Not at all"
4 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
6 month · "Quite a bit" or "A great deal"
26 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
9 month · "Quite a bit" or "A great deal"
15 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
9 month · "Somewhat," "A little," or "Not at all"
3 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
15 month · "Quite a bit" or "A great deal"
8 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
18 month · "Quite a bit" or "A great deal"
8 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
18 month · "Somewhat," "A little," or "Not at all"
0 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
21 month · "Quite a bit" or "A great deal"
16 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
21 month · "Somewhat," "A little," or "Not at all"
0 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
24 month · "Quite a bit" or "A great deal"
10 Participants
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
24 month · "Somewhat," "A little," or "Not at all"
0 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How important is attending school in-person to your child's overall health? * Dichotomized into: ("Not at all important", "A little important", "Somewhat important") vs. ("Very important", "Extremely important") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
3 month · "Very important" or "Extremely important"
21 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
3 month · "Not at all important", "A little important", or "Somewhat important"
9 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
9 month · "Very important" or "Extremely important"
15 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
9 month · "Not at all important", "A little important", or "Somewhat important"
3 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
15 month · "Very important" or "Extremely important"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
24 month · "Very important" or "Extremely important"
9 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
24 month · "Not at all important", "A little important", or "Somewhat important"
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
15 month · "Not at all important", "A little important", or "Somewhat important"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
18 month · "Very important" or "Extremely important"
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
18 month · "Not at all important", "A little important", or "Somewhat important"
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
21 month · "Very important" or "Extremely important"
13 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
21 month · "Not at all important", "A little important", or "Somewhat important"
3 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
6 month · "Very important" or "Extremely important"
21 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
6 month · "Not at all important", "A little important", or "Somewhat important"
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
Baseline · "Very important" or "Extremely important"
32 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
Baseline · "Not at all important", "A little important", or "Somewhat important"
8 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, and impact on family. Survey will be analyzed qualitatively. * Compared to fully virtual school, how much better or worse is attending any school in-person for your child? * Dichotomized into: ("Quite a bit worse", "Somewhat worse", "A little bit worse", "Neither better nor worse") vs. ("A little bit better", "Somewhat better", "Quite a bit better") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
3 month · "A little bit better", "Somewhat better", or "Quite a bit better"
27 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
3 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
6 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
9 month · "A little bit better", "Somewhat better", or "Quite a bit better"
16 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
15 month · "A little bit better", "Somewhat better", or "Quite a bit better"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
18 month · "A little bit better", "Somewhat better", or "Quite a bit better"
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
21 month · "A little bit better", "Somewhat better", or "Quite a bit better"
15 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
24 month · "A little bit better", "Somewhat better", or "Quite a bit better"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
24 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
Baseline · "A little bit better", "Somewhat better", or "Quite a bit better"
36 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
Baseline · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
6 month · "A little bit better", "Somewhat better", or "Quite a bit better"
26 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
9 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
15 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
18 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
21 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
0 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How much of your child's therapy needs are only met by attending school in-person? * Dichotomized into: ("None", "A few", "Some" vs. "Most", "All") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
Baseline · "Most", "All"
9 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
6 month · "None", "A few", "Some"
10 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
9 month · "Most", "All"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
15 month · "Most", "All"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
15 month · "None", "A few", "Some"
3 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
18 month · "None", "A few", "Some"
4 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
21 month · "None", "A few", "Some"
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
24 month · "Most", "All"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
Baseline · "None", "A few", "Some"
22 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
3 month · "Most", "All"
9 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
3 month · "None", "A few", "Some"
14 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
6 month · "Most", "All"
10 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
9 month · "None", "A few", "Some"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
18 month · "Most", "All"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
21 month · "Most", "All"
4 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
24 month · "None", "A few", "Some"
6 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How positive or negative is your child attending school in-person for...your family * Dichotomized into: ("Very negative", "Somewhat negative", "A little negative", "Neutral") vs. ("A little positive", "Somewhat positive", "Very positive") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
Baseline · "A little positive", "Somewhat positive", or "Very positive"
39 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
Baseline · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
3 month · "A little positive", "Somewhat positive", or "Very positive"
29 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
3 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
6 month · "A little positive", "Somewhat positive", or "Very positive"
27 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
9 month · "A little positive", "Somewhat positive", or "Very positive"
18 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
9 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
15 month · "A little positive", "Somewhat positive", or "Very positive"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
15 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
21 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
24 month · "A little positive", "Somewhat positive", or "Very positive"
10 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
24 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
6 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
18 month · "A little positive", "Somewhat positive", or "Very positive"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
18 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
21 month · "A little positive", "Somewhat positive", or "Very positive"
16 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * How positive or negative is your child attending school in-person for...the staff and teachers * Dichotomized into: ("Very negative", "Somewhat negative", "A little negative", "Neutral") vs. ("A little positive", "Somewhat positive", "Very positive") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
Baseline · "A little positive", "Somewhat positive", or "Very positive"
32 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
Baseline · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
6 month · "A little positive", "Somewhat positive", or "Very positive"
22 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
6 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
6 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
9 month · "A little positive", "Somewhat positive", or "Very positive"
15 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
15 month · "A little positive", "Somewhat positive", or "Very positive"
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
18 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
21 month · "A little positive", "Somewhat positive", or "Very positive"
12 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
21 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
3 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
24 month · "A little positive", "Somewhat positive", or "Very positive"
10 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
24 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
3 month · "A little positive", "Somewhat positive", or "Very positive"
23 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
3 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
6 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
9 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
15 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
18 month · "A little positive", "Somewhat positive", or "Very positive"
6 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. * Does your child attending school in-person help the adults in your family to keep their jobs? * Response options: Yes / No * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
3 month · Yes
24 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
3 month · No
5 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
6 month · Yes
23 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
15 month · Yes
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
15 month · No
1 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
18 month · Yes
7 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
18 month · No
0 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
21 month · Yes
14 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
21 month · No
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
24 month · Yes
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
24 month · No
2 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
Baseline · Yes
31 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
Baseline · No
8 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
6 month · No
5 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
9 month · Yes
13 Participants
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
9 month · No
5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the number of people around your child at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Number of People
3 month · "Not at all", "A little", or "Somewhat" comfortable
19 Participants
Caregiver Change in Barriers to School Attendance: Number of People
9 month · "Not at all", "A little", or "Somewhat" comfortable
6 Participants
Caregiver Change in Barriers to School Attendance: Number of People
21 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Number of People
24 month · "Very" or "Extremely" comfortable
7 Participants
Caregiver Change in Barriers to School Attendance: Number of People
24 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Number of People
Baseline · "Very" or "Extremely" comfortable
21 Participants
Caregiver Change in Barriers to School Attendance: Number of People
Baseline · "Not at all", "A little", or "Somewhat" comfortable
19 Participants
Caregiver Change in Barriers to School Attendance: Number of People
3 month · "Very" or "Extremely" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: Number of People
6 month · "Very" or "Extremely" comfortable
15 Participants
Caregiver Change in Barriers to School Attendance: Number of People
6 month · "Not at all", "A little", or "Somewhat" comfortable
12 Participants
Caregiver Change in Barriers to School Attendance: Number of People
9 month · "Very" or "Extremely" comfortable
11 Participants
Caregiver Change in Barriers to School Attendance: Number of People
15 month · "Very" or "Extremely" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Number of People
15 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Number of People
18 month · "Very" or "Extremely" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: Number of People
18 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Number of People
21 month · "Very" or "Extremely" comfortable
12 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with how close people have to be to your child at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Proximity
Baseline · "Very" or "Extremely" comfortable
20 Participants
Caregiver Change in Barriers to School Attendance: Proximity
Baseline · "Not at all", "A little", or "Somewhat" comfortable
20 Participants
Caregiver Change in Barriers to School Attendance: Proximity
3 month · "Very" or "Extremely" comfortable
9 Participants
Caregiver Change in Barriers to School Attendance: Proximity
6 month · "Very" or "Extremely" comfortable
13 Participants
Caregiver Change in Barriers to School Attendance: Proximity
24 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Proximity
3 month · "Not at all", "A little", or "Somewhat" comfortable
20 Participants
Caregiver Change in Barriers to School Attendance: Proximity
6 month · "Not at all", "A little", or "Somewhat" comfortable
14 Participants
Caregiver Change in Barriers to School Attendance: Proximity
9 month · "Very" or "Extremely" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: Proximity
9 month · "Not at all", "A little", or "Somewhat" comfortable
8 Participants
Caregiver Change in Barriers to School Attendance: Proximity
15 month · "Very" or "Extremely" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Proximity
15 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Proximity
18 month · "Very" or "Extremely" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Proximity
18 month · "Not at all", "A little", or "Somewhat" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: Proximity
21 month · "Very" or "Extremely" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: Proximity
21 month · "Not at all", "A little", or "Somewhat" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: Proximity
24 month · "Very" or "Extremely" comfortable
6 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the amount personal protective equipment (PPE), such as masks and gloves, available at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: PPE
6 month · "Not at all", "A little", or "Somewhat" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: PPE
21 month · "Very" or "Extremely" comfortable
11 Participants
Caregiver Change in Barriers to School Attendance: PPE
Baseline · "Very" or "Extremely" comfortable
27 Participants
Caregiver Change in Barriers to School Attendance: PPE
Baseline · "Not at all", "A little", or "Somewhat" comfortable
13 Participants
Caregiver Change in Barriers to School Attendance: PPE
3 month · "Very" or "Extremely" comfortable
16 Participants
Caregiver Change in Barriers to School Attendance: PPE
3 month · "Not at all", "A little", or "Somewhat" comfortable
13 Participants
Caregiver Change in Barriers to School Attendance: PPE
6 month · "Very" or "Extremely" comfortable
16 Participants
Caregiver Change in Barriers to School Attendance: PPE
9 month · "Very" or "Extremely" comfortable
17 Participants
Caregiver Change in Barriers to School Attendance: PPE
9 month · "Not at all", "A little", or "Somewhat" comfortable
1 Participants
Caregiver Change in Barriers to School Attendance: PPE
15 month · "Very" or "Extremely" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: PPE
15 month · "Not at all", "A little", or "Somewhat" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: PPE
18 month · "Very" or "Extremely" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: PPE
18 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: PPE
21 month · "Not at all", "A little", or "Somewhat" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: PPE
24 month · "Very" or "Extremely" comfortable
7 Participants
Caregiver Change in Barriers to School Attendance: PPE
24 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the amount of COVID-19 testing among school staff and classmates? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Testing
Baseline · "Very" or "Extremely" comfortable
30 Participants
Caregiver Change in Barriers to School Attendance: Testing
9 month · "Very" or "Extremely" comfortable
11 Participants
Caregiver Change in Barriers to School Attendance: Testing
9 month · "Not at all", "A little", or "Somewhat" comfortable
7 Participants
Caregiver Change in Barriers to School Attendance: Testing
24 month · "Very" or "Extremely" comfortable
8 Participants
Caregiver Change in Barriers to School Attendance: Testing
24 month · "Not at all", "A little", or "Somewhat" comfortable
2 Participants
Caregiver Change in Barriers to School Attendance: Testing
Baseline · "Not at all", "A little", or "Somewhat" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: Testing
3 month · "Very" or "Extremely" comfortable
19 Participants
Caregiver Change in Barriers to School Attendance: Testing
3 month · "Not at all", "A little", or "Somewhat" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: Testing
6 month · "Very" or "Extremely" comfortable
13 Participants
Caregiver Change in Barriers to School Attendance: Testing
6 month · "Not at all", "A little", or "Somewhat" comfortable
13 Participants
Caregiver Change in Barriers to School Attendance: Testing
15 month · "Very" or "Extremely" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Testing
15 month · "Not at all", "A little", or "Somewhat" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: Testing
18 month · "Very" or "Extremely" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: Testing
18 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Testing
21 month · "Very" or "Extremely" comfortable
12 Participants
Caregiver Change in Barriers to School Attendance: Testing
21 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with how closely parents of classmates follow recommendations to keep your child safe? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Following Recommendations
Baseline · "Very" or "Extremely" comfortable
23 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
Baseline · "Not at all", "A little", or "Somewhat" comfortable
17 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
3 month · "Very" or "Extremely" comfortable
10 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
24 month · "Very" or "Extremely" comfortable
7 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
24 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
3 month · "Not at all", "A little", or "Somewhat" comfortable
19 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
6 month · "Very" or "Extremely" comfortable
14 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
6 month · "Not at all", "A little", or "Somewhat" comfortable
12 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
9 month · "Very" or "Extremely" comfortable
14 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
9 month · "Not at all", "A little", or "Somewhat" comfortable
2 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
15 month · "Very" or "Extremely" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
15 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
18 month · "Very" or "Extremely" comfortable
5 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
18 month · "Not at all", "A little", or "Somewhat" comfortable
3 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
21 month · "Very" or "Extremely" comfortable
11 Participants
Caregiver Change in Barriers to School Attendance: Following Recommendations
21 month · "Not at all", "A little", or "Somewhat" comfortable
4 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely vs not. * How difficult is it to transport your child to or from school as a result of COVID-19? * Dichotomized as: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Transportation
Baseline · "Not at all", "A little", or "Somewhat" difficult
39 Participants
Caregiver Change in Barriers to School Attendance: Transportation
Baseline · "Very" or "Extremely" difficult
1 Participants
Caregiver Change in Barriers to School Attendance: Transportation
3 month · "Very" or "Extremely" difficult
0 Participants
Caregiver Change in Barriers to School Attendance: Transportation
3 month · "Not at all", "A little", or "Somewhat" difficult
29 Participants
Caregiver Change in Barriers to School Attendance: Transportation
6 month · "Very" or "Extremely" difficult
1 Participants
Caregiver Change in Barriers to School Attendance: Transportation
6 month · "Not at all", "A little", or "Somewhat" difficult
27 Participants
Caregiver Change in Barriers to School Attendance: Transportation
9 month · "Very" or "Extremely" difficult
1 Participants
Caregiver Change in Barriers to School Attendance: Transportation
9 month · "Not at all", "A little", or "Somewhat" difficult
17 Participants
Caregiver Change in Barriers to School Attendance: Transportation
15 month · "Very" or "Extremely" difficult
0 Participants
Caregiver Change in Barriers to School Attendance: Transportation
15 month · "Not at all", "A little", or "Somewhat" difficult
8 Participants
Caregiver Change in Barriers to School Attendance: Transportation
18 month · "Very" or "Extremely" difficult
0 Participants
Caregiver Change in Barriers to School Attendance: Transportation
18 month · "Not at all", "A little", or "Somewhat" difficult
8 Participants
Caregiver Change in Barriers to School Attendance: Transportation
21 month · "Very" or "Extremely" difficult
0 Participants
Caregiver Change in Barriers to School Attendance: Transportation
21 month · "Not at all", "A little", or "Somewhat" difficult
16 Participants
Caregiver Change in Barriers to School Attendance: Transportation
24 month · "Very" or "Extremely" difficult
0 Participants
Caregiver Change in Barriers to School Attendance: Transportation
24 month · "Not at all", "A little", or "Somewhat" difficult
10 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely vs not. * In your child's school, do they have access to necessary facilities to wash? * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Wash
3 month · "Yes, all of the time" or "Yes, most of the time"
29 Participants
Caregiver Change in Barriers to School Attendance: Wash
9 month · "Yes, all of the time" or "Yes, most of the time"
18 Participants
Caregiver Change in Barriers to School Attendance: Wash
9 month · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
15 month · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
18 month · "Yes, all of the time" or "Yes, most of the time"
8 Participants
Caregiver Change in Barriers to School Attendance: Wash
21 month · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
Baseline · "Yes, all of the time" or "Yes, most of the time"
39 Participants
Caregiver Change in Barriers to School Attendance: Wash
Baseline · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
3 month · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
6 month · "Yes, all of the time" or "Yes, most of the time"
28 Participants
Caregiver Change in Barriers to School Attendance: Wash
6 month · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
15 month · "Yes, all of the time" or "Yes, most of the time"
8 Participants
Caregiver Change in Barriers to School Attendance: Wash
18 month · "Some of the time", "Rarely", or "Not at all"
0 Participants
Caregiver Change in Barriers to School Attendance: Wash
21 month · "Yes, all of the time" or "Yes, most of the time"
16 Participants
Caregiver Change in Barriers to School Attendance: Wash
24 month · "Yes, all of the time" or "Yes, most of the time"
10 Participants
Caregiver Change in Barriers to School Attendance: Wash
24 month · "Some of the time", "Rarely", or "Not at all"
0 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * While in school, is your child required to be in close contact (i.e., within 6 ft) with others? 'Others' includes teachers, aides, nurses, and classmates. * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Close Contact
9 month · "Yes, all of the time" or "Yes, most of the time"
15 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
9 month · "Some of the time", "Rarely", or "Not at all"
3 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
Baseline · "Yes, all of the time" or "Yes, most of the time"
24 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
Baseline · "Some of the time", "Rarely", or "Not at all"
16 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
3 month · "Yes, all of the time" or "Yes, most of the time"
21 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
3 month · "Some of the time", "Rarely", or "Not at all"
8 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
6 month · "Yes, all of the time" or "Yes, most of the time"
24 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
6 month · "Some of the time", "Rarely", or "Not at all"
4 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
15 month · "Yes, all of the time" or "Yes, most of the time"
6 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
15 month · "Some of the time", "Rarely", or "Not at all"
2 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
18 month · "Yes, all of the time" or "Yes, most of the time"
6 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
18 month · "Some of the time", "Rarely", or "Not at all"
2 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
21 month · "Yes, all of the time" or "Yes, most of the time"
13 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
21 month · "Some of the time", "Rarely", or "Not at all"
2 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
24 month · "Yes, all of the time" or "Yes, most of the time"
8 Participants
Caregiver Change in Barriers to School Attendance: Close Contact
24 month · "Some of the time", "Rarely", or "Not at all"
2 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Survey will have following questions which will be answered dichotomously very/extremely vs not. * While in school, is your child able to wear a mask? * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Barriers to School Attendance: Masking
6 month · "Some of the time", "Rarely", or "Not at all"
5 Participants
Caregiver Change in Barriers to School Attendance: Masking
9 month · "Some of the time", "Rarely", or "Not at all"
4 Participants
Caregiver Change in Barriers to School Attendance: Masking
15 month · "Yes, all of the time" or "Yes, most of the time"
3 Participants
Caregiver Change in Barriers to School Attendance: Masking
15 month · "Some of the time", "Rarely", or "Not at all"
5 Participants
Caregiver Change in Barriers to School Attendance: Masking
Baseline · "Yes, all of the time" or "Yes, most of the time"
30 Participants
Caregiver Change in Barriers to School Attendance: Masking
Baseline · "Some of the time", "Rarely", or "Not at all"
10 Participants
Caregiver Change in Barriers to School Attendance: Masking
3 month · "Yes, all of the time" or "Yes, most of the time"
23 Participants
Caregiver Change in Barriers to School Attendance: Masking
3 month · "Some of the time", "Rarely", or "Not at all"
6 Participants
Caregiver Change in Barriers to School Attendance: Masking
6 month · "Yes, all of the time" or "Yes, most of the time"
23 Participants
Caregiver Change in Barriers to School Attendance: Masking
9 month · "Yes, all of the time" or "Yes, most of the time"
14 Participants
Caregiver Change in Barriers to School Attendance: Masking
18 month · "Yes, all of the time" or "Yes, most of the time"
6 Participants
Caregiver Change in Barriers to School Attendance: Masking
18 month · "Some of the time", "Rarely", or "Not at all"
2 Participants
Caregiver Change in Barriers to School Attendance: Masking
21 month · "Yes, all of the time" or "Yes, most of the time"
7 Participants
Caregiver Change in Barriers to School Attendance: Masking
21 month · "Some of the time", "Rarely", or "Not at all"
9 Participants
Caregiver Change in Barriers to School Attendance: Masking
24 month · "Yes, all of the time" or "Yes, most of the time"
5 Participants
Caregiver Change in Barriers to School Attendance: Masking
24 month · "Some of the time", "Rarely", or "Not at all"
5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Participants will answer the following survey question in Yes/No: * "Teachers/staff have asked for my child to attend school."- Y/N * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
Baseline · No
31 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
3 month · Yes
7 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
15 month · No
4 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
18 month · Yes
3 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
Baseline · Yes
7 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
3 month · No
22 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
6 month · Yes
7 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
18 month · No
5 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
21 month · Yes
5 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
21 month · No
10 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
24 month · Yes
3 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
24 month · No
7 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
6 month · No
20 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
9 month · Yes
6 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
9 month · No
12 Participants
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
15 month · Yes
4 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

Participant will be asked the attendance question in survey. It will be answered in Yes/No. * Currently, is child attending school in-person, either full-time or as part of a hybrid or part-time schedule? Y/N * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=47 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Option and Practice: School Attendance
18 month · No
0 Participants
Caregiver Change in Option and Practice: School Attendance
21 month · Yes
17 Participants
Caregiver Change in Option and Practice: School Attendance
24 month · No
0 Participants
Caregiver Change in Option and Practice: School Attendance
Baseline · Yes
38 Participants
Caregiver Change in Option and Practice: School Attendance
Baseline · No
2 Participants
Caregiver Change in Option and Practice: School Attendance
3 month · Yes
29 Participants
Caregiver Change in Option and Practice: School Attendance
3 month · No
1 Participants
Caregiver Change in Option and Practice: School Attendance
6 month · Yes
25 Participants
Caregiver Change in Option and Practice: School Attendance
6 month · No
2 Participants
Caregiver Change in Option and Practice: School Attendance
9 month · Yes
17 Participants
Caregiver Change in Option and Practice: School Attendance
9 month · No
1 Participants
Caregiver Change in Option and Practice: School Attendance
15 month · Yes
8 Participants
Caregiver Change in Option and Practice: School Attendance
15 month · No
0 Participants
Caregiver Change in Option and Practice: School Attendance
18 month · Yes
8 Participants
Caregiver Change in Option and Practice: School Attendance
21 month · No
0 Participants
Caregiver Change in Option and Practice: School Attendance
24 month · Yes
10 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point. This question is only asked to participants who indicate that their child is not currently attending school. In this aim, few to no participants were asked this question. Only 2 participants were asked this question in Aim 1b.

Participant will be asked the attendance question in survey. It will be answered in Yes/No * Currently, if participant wanted, could the child attend school in-person, either full-time or as part of a hybrid or part-time schedule? * Survey branching logic asked this question only to participants whose child was not currently attending school in person, either full-time or as part of a hybrid or part-time schedule. The number analyzed represents the number of participants that answered this question. * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

Outcome measures

Outcome measures
Measure
Staff and Children
n=2 Participants
The enrollment rate was not stratified by staff and caregiver/child dyad during data collection.
School Staff
50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
Caregiver Change in Option and Practice: Option to Attend School
3 month · Yes
1 Participants
Caregiver Change in Option and Practice: Option to Attend School
3 month · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
6 month · Yes
1 Participants
Caregiver Change in Option and Practice: Option to Attend School
6 month · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
15 month · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
Baseline · Yes
1 Participants
Caregiver Change in Option and Practice: Option to Attend School
Baseline · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
9 month · Yes
1 Participants
Caregiver Change in Option and Practice: Option to Attend School
9 month · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
15 month · Yes
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
18 month · Yes
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
18 month · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
21 month · Yes
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
21 month · No
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
24 month · Yes
0 Participants
Caregiver Change in Option and Practice: Option to Attend School
24 month · No
0 Participants

Adverse Events

Children With Medical Complexity (CMC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

School Staff

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ryan Coller

University of Wisconsin School of Medicine and Public Health

Phone: 608-263-9408

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place