Trial Outcomes & Findings for ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance (NCT NCT04895085)

NCT ID: NCT04895085

Last Updated: 2024-06-07

Results Overview

Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

Study duration (up to 21 months)

Results posted on

2024-06-07

Participant Flow

The protocol enrollment, started, and completed values reflect caregiver/child dyads. All dyads assigned to the intervention had one caregiver to one child (n = 51 caregivers, n = 51 children). All participants were assigned to the intervention group.

Participant milestones

Participant milestones
Measure
Caregiver of Children With Medical Complexity (CMC)
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
51
Overall Study
COMPLETED
48
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Caregiver of Children With Medical Complexity (CMC)
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
Death
1
Overall Study
Withdrawal by Subject
1
Overall Study
No longer eligible: Moved from area
1

Baseline Characteristics

ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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
n=51 Participants
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=102 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
51 Participants
n=7 Participants
51 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=5 Participants
0 Participants
n=7 Participants
51 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
39 years
n=5 Participants
9 years
n=7 Participants
NA years
n=5 Participants
Sex: Female, Male
Female
48 Participants
n=5 Participants
20 Participants
n=7 Participants
68 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
31 Participants
n=7 Participants
34 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
n=5 Participants
44 Participants
n=7 Participants
90 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 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
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
46 Participants
n=5 Participants
42 Participants
n=7 Participants
88 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
51 Participants
n=5 Participants
51 Participants
n=7 Participants
102 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Population: The number of participants analyzed must reflect the number of participants approached in addition to those consented.

Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=84 Participants
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 Participants Consented Compared to Number of Participants Approached
Number approached, consented
51 Caregiver/child dyads
Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached
Number approached, not consented
33 Caregiver/child dyads

PRIMARY outcome

Timeframe: Every week up to 21 months

Feasibility of home based COVID-19 testing will be evaluated by the mean number of weekly in home COVID-19 tests run by parents/caregivers. Data will be collected by survey.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=3254 BinaxNOW Rapid Antigen COVID-19 Tests
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 Mean Number of Weekly in Home COVID-19 Tests
1.8 BinaxNow Antigen COVID-19 Tests per week
Standard Deviation 0.3

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be collected by survey. * Tests expected: Various scenarios factor into the tests expected value. Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no "expected" tests for caregivers). Additionally, caregivers were not expected to test for 90 days after their child tested positive. * Tests completed: Caregivers were allowed to test more often than twice a week if appropriate (e.g., exposure to COVID-19). All symptomatic-only tests were not considered expected tests. These factors allowed the number of tests completed to exceed the number of tests expected.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=3254 BinaxNOW Rapid Antigen COVID-19 Tests
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 Home: Number of Total Tests Completed as Compared to Number of Tests Expected
Number of tests completed
3254 BinaxNOW Rapid Antigen COVID-19 Tests
Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected
Number of tests expected
2572 BinaxNOW Rapid Antigen COVID-19 Tests

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be collected from parents via survey.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=3254 BinaxNOW Rapid Antigen COVID-19 Tests
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
729 Symptomatic BinaxNow Rapid Antigen Tests

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be collected from parents via survey.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=3254 BinaxNOW Rapid Antigen COVID-19 Tests
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
Number of positive COVID-19 tests
39 BinaxNow Rapid Antigen COVID-19 Tests
Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed
Total number of tests performed
3254 BinaxNow Rapid Antigen COVID-19 Tests

PRIMARY outcome

Timeframe: Study duration (up to 21 months)

Data will be collected from parents via survey.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=109 COVID-19 PCR Tests
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
Number of negative confirmatory PCR tests
1 Polymerase chain reaction for COVID-19
Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing
Total COVID-19 PCR tests
109 Polymerase chain reaction for COVID-19

PRIMARY outcome

Timeframe: At month 3

Data will be collected from parents via survey. \- Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no "expected" tests for caregivers).

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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.
Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants
Participants opting into surveillance testing
32 Participants
Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants
Participants not opting into surveillance testing
19 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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)

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
9-month · "None", "A few", "Some", "Don't Know"
35 Participants
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
16 Participants
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"
23 Participants
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
12 Participants
Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
Baseline · "None", "A few", "Some", "Don't Know"
39 Participants
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
9 Participants
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"
39 Participants
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
12 Participants
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"
34 Participants
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
10 Participants
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
15 Participants
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"
24 Participants
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
15 Participants
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"
26 Participants
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
17 Participants
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"
27 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Susceptibility: School Takes Precautions
Baseline · "Very" or "Extremely" comfortable
24 Participants
Change in Susceptibility: School Takes Precautions
Baseline · "Not at all", "A little", or "Somewhat" comfortable
27 Participants
Change in Susceptibility: School Takes Precautions
3 months · "Very" or "Extremely" comfortable
17 Participants
Change in Susceptibility: School Takes Precautions
3 months · "Not at all", "A little", or "Somewhat" comfortable
31 Participants
Change in Susceptibility: School Takes Precautions
6 months · "Very" or "Extremely" comfortable
20 Participants
Change in Susceptibility: School Takes Precautions
6 months · "Not at all", "A little", or "Somewhat" comfortable
26 Participants
Change in Susceptibility: School Takes Precautions
9-12 months · "Very" or "Extremely" comfortable
24 Participants
Change in Susceptibility: School Takes Precautions
9-12 months · "Not at all", "A little", or "Somewhat" comfortable
21 Participants
Change in Susceptibility: School Takes Precautions
15 months · "Very" or "Extremely" comfortable
16 Participants
Change in Susceptibility: School Takes Precautions
15 months · "Not at all", "A little", or "Somewhat" comfortable
23 Participants
Change in Susceptibility: School Takes Precautions
18 months · "Very" or "Extremely" comfortable
16 Participants
Change in Susceptibility: School Takes Precautions
18 months · "Not at all", "A little", or "Somewhat" comfortable
21 Participants
Change in Susceptibility: School Takes Precautions
21 months · "Very" or "Extremely" comfortable
13 Participants
Change in Susceptibility: School Takes Precautions
21 months · "Not at all", "A little", or "Somewhat" comfortable
30 Participants
Change in Susceptibility: School Takes Precautions
24 months · "Very" or "Extremely" comfortable
21 Participants
Change in Susceptibility: School Takes Precautions
24 months · "Not at all", "A little", or "Somewhat" comfortable
24 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Susceptibility: Likely to Get COVID-19
Baseline · "Very" or "Extremely" likely
22 Participants
Change in Susceptibility: Likely to Get COVID-19
Baseline · "Not at all", "A little", or "Somewhat" likely
29 Participants
Change in Susceptibility: Likely to Get COVID-19
3 months · "Very" or "Extremely" likely
18 Participants
Change in Susceptibility: Likely to Get COVID-19
3 months · "Not at all", "A little", or "Somewhat" likely
30 Participants
Change in Susceptibility: Likely to Get COVID-19
6 months · "Very" or "Extremely" likely
21 Participants
Change in Susceptibility: Likely to Get COVID-19
6 months · "Not at all", "A little", or "Somewhat" likely
24 Participants
Change in Susceptibility: Likely to Get COVID-19
9 months · "Very" or "Extremely" likely
16 Participants
Change in Susceptibility: Likely to Get COVID-19
9 months · "Not at all", "A little", or "Somewhat" likely
28 Participants
Change in Susceptibility: Likely to Get COVID-19
15 months · "Very" or "Extremely" likely
19 Participants
Change in Susceptibility: Likely to Get COVID-19
15 months · "Not at all", "A little", or "Somewhat" likely
20 Participants
Change in Susceptibility: Likely to Get COVID-19
18 months · "Very" or "Extremely" likely
23 Participants
Change in Susceptibility: Likely to Get COVID-19
18 months · "Not at all", "A little", or "Somewhat" likely
16 Participants
Change in Susceptibility: Likely to Get COVID-19
21 months · "Very" or "Extremely" likely
23 Participants
Change in Susceptibility: Likely to Get COVID-19
21 months · "Not at all", "A little", or "Somewhat" likely
19 Participants
Change in Susceptibility: Likely to Get COVID-19
24 months · "Very" or "Extremely" likely
25 Participants
Change in Susceptibility: Likely to Get COVID-19
24 months · "Not at all", "A little", or "Somewhat" likely
20 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Participants for Perceived Severity Survey Question: Health Severely Affected
15 month · "Very" or "Extremely" likely
20 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
15 month · "Not at all", "A little", or "Somewhat" likely
18 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
18 month · "Very" or "Extremely" likely
25 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
18 month · "Not at all", "A little", or "Somewhat" likely
14 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
21 month · "Very" or "Extremely" likely
29 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
21 month · "Not at all", "A little", or "Somewhat" likely
14 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
24 month · "Very" or "Extremely" likely
26 Participants
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
24 month · "Not at all", "A little", or "Somewhat" likely
19 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Participants to the Perceived Severity Survey Question: Health Permanently Reduced
21-month · "Very" or "Extremely" likely
18 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
21-month · "Not at all", "A little", or "Somewhat" likely
25 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
24-month · "Very" or "Extremely" likely
19 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
24-month · "Not at all", "A little", or "Somewhat" likely
26 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
15-month · "Very" or "Extremely" likely
17 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
15-month · "Not at all", "A little", or "Somewhat" likely
21 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
18-month · "Very" or "Extremely" likely
20 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
18-month · "Not at all", "A little", or "Somewhat" likely
19 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Participants to the Perceived Severity Survey Question: Grave Health Consequences
15 month · "Very" or "Extremely" likely
17 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
15 month · "Not at all", "A little", or "Somewhat" likely
21 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
18 month · "Very" or "Extremely" likely
21 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
18 month · "Not at all", "A little", or "Somewhat" likely
18 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
21 month · "Very" or "Extremely" likely
19 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
21 month · "Not at all", "A little", or "Somewhat" likely
24 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
24 month · "Very" or "Extremely" likely
20 Participants
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
24 month · "Not at all", "A little", or "Somewhat" likely
24 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 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?"

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
18 month · "Somewhat," "A little," or "Not at all"
12 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
Baseline · "Quite a bit" or "A great deal"
33 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
Baseline · "Somewhat," "A little," or "Not at all"
18 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
3 month · "Quite a bit" or "A great deal"
29 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
3 month · "Somewhat," "A little," or "Not at all"
19 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
6 month · "Quite a bit" or "A great deal"
29 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
6 month · "Somewhat," "A little," or "Not at all"
17 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
9 month · "Quite a bit" or "A great deal"
35 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
9 month · "Somewhat," "A little," or "Not at all"
10 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
15 month · "Quite a bit" or "A great deal"
28 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
15 month · "Somewhat," "A little," or "Not at all"
11 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
18 month · "Quite a bit" or "A great deal"
27 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
21 month · "Quite a bit" or "A great deal"
33 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
21 month · "Somewhat," "A little," or "Not at all"
9 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
24 month · "Quite a bit" or "A great deal"
35 Participants
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
24 month · "Somewhat," "A little," or "Not at all"
10 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Perceived Benefits to Attend School: Important to Health
3 month · "Very important" or "Extremely important"
29 Participants
Change in Perceived Benefits to Attend School: Important to Health
Baseline · "Very important" or "Extremely important"
37 Participants
Change in Perceived Benefits to Attend School: Important to Health
Baseline · "Not at all important", "A little important", or "Somewhat important"
14 Participants
Change in Perceived Benefits to Attend School: Important to Health
3 month · "Not at all important", "A little important", or "Somewhat important"
19 Participants
Change in Perceived Benefits to Attend School: Important to Health
6 month · "Very important" or "Extremely important"
31 Participants
Change in Perceived Benefits to Attend School: Important to Health
6 month · "Not at all important", "A little important", or "Somewhat important"
15 Participants
Change in Perceived Benefits to Attend School: Important to Health
9 month · "Very important" or "Extremely important"
34 Participants
Change in Perceived Benefits to Attend School: Important to Health
9 month · "Not at all important", "A little important", or "Somewhat important"
11 Participants
Change in Perceived Benefits to Attend School: Important to Health
15 month · "Very important" or "Extremely important"
29 Participants
Change in Perceived Benefits to Attend School: Important to Health
15 month · "Not at all important", "A little important", or "Somewhat important"
10 Participants
Change in Perceived Benefits to Attend School: Important to Health
18 month · "Very important" or "Extremely important"
31 Participants
Change in Perceived Benefits to Attend School: Important to Health
18 month · "Not at all important", "A little important", or "Somewhat important"
8 Participants
Change in Perceived Benefits to Attend School: Important to Health
21 month · "Very important" or "Extremely important"
32 Participants
Change in Perceived Benefits to Attend School: Important to Health
21 month · "Not at all important", "A little important", or "Somewhat important"
10 Participants
Change in Perceived Benefits to Attend School: Important to Health
24 month · "Very important" or "Extremely important"
29 Participants
Change in Perceived Benefits to Attend School: Important to Health
24 month · "Not at all important", "A little important", or "Somewhat important"
15 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Perceived Benefits to Attend School: In-person Schooling
Baseline · "A little bit better", "Somewhat better", or "Quite a bit better"
35 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
Baseline · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
15 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
3 month · "A little bit better", "Somewhat better", or "Quite a bit better"
33 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
3 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
15 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
6 month · "A little bit better", "Somewhat better", or "Quite a bit better"
32 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
6 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
14 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
9 month · "A little bit better", "Somewhat better", or "Quite a bit better"
35 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
9 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
10 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
15 month · "A little bit better", "Somewhat better", or "Quite a bit better"
32 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
15 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
7 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
18 month · "A little bit better", "Somewhat better", or "Quite a bit better"
29 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
18 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
10 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
21 month · "A little bit better", "Somewhat better", or "Quite a bit better"
37 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
21 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
6 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
24 month · "A little bit better", "Somewhat better", or "Quite a bit better"
36 Participants
Change in Perceived Benefits to Attend School: In-person Schooling
24 month · "Quite a bit worse", "Somewhat worse", "A little bit worse", or "Neither better nor worse"
9 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Perceived Benefits to Attend School: Therapy Needs
Baseline · "Most", "All"
38 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
Baseline · "None", "A few", "Some"
13 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
3 month · "Most", "All"
32 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
3 month · "None", "A few", "Some"
16 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
6 month · "Most", "All"
33 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
6 month · "None", "A few", "Some"
13 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
9 month · "Most", "All"
31 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
9 month · "None", "A few", "Some"
14 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
15 month · "Most", "All"
26 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
15 month · "None", "A few", "Some"
13 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
18 month · "Most", "All"
27 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
18 month · "None", "A few", "Some"
12 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
21 month · "Most", "All"
29 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
21 month · "None", "A few", "Some"
14 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
24 month · "Most", "All"
30 Participants
Change in Perceived Benefits to Attend School: Therapy Needs
24 month · "None", "A few", "Some"
15 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Perceived Benefits to Attend School: Positive for Family
Baseline · "A little positive", "Somewhat positive", or "Very positive"
37 Participants
Change in Perceived Benefits to Attend School: Positive for Family
Baseline · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
13 Participants
Change in Perceived Benefits to Attend School: Positive for Family
3 month · "A little positive", "Somewhat positive", or "Very positive"
37 Participants
Change in Perceived Benefits to Attend School: Positive for Family
3 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
11 Participants
Change in Perceived Benefits to Attend School: Positive for Family
6 month · "A little positive", "Somewhat positive", or "Very positive"
38 Participants
Change in Perceived Benefits to Attend School: Positive for Family
6 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
8 Participants
Change in Perceived Benefits to Attend School: Positive for Family
9 month · "A little positive", "Somewhat positive", or "Very positive"
38 Participants
Change in Perceived Benefits to Attend School: Positive for Family
9 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
7 Participants
Change in Perceived Benefits to Attend School: Positive for Family
15 month · "A little positive", "Somewhat positive", or "Very positive"
31 Participants
Change in Perceived Benefits to Attend School: Positive for Family
15 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
8 Participants
Change in Perceived Benefits to Attend School: Positive for Family
18 month · "A little positive", "Somewhat positive", or "Very positive"
30 Participants
Change in Perceived Benefits to Attend School: Positive for Family
18 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
9 Participants
Change in Perceived Benefits to Attend School: Positive for Family
21 month · "A little positive", "Somewhat positive", or "Very positive"
36 Participants
Change in Perceived Benefits to Attend School: Positive for Family
21 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
7 Participants
Change in Perceived Benefits to Attend School: Positive for Family
24 month · "A little positive", "Somewhat positive", or "Very positive"
37 Participants
Change in Perceived Benefits to Attend School: Positive for Family
24 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
8 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Perceived Benefits to Attend School: Positive for Staff
Baseline · "A little positive", "Somewhat positive", or "Very positive"
34 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
Baseline · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
16 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
3 month · "A little positive", "Somewhat positive", or "Very positive"
36 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
3 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
11 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
6 month · "A little positive", "Somewhat positive", or "Very positive"
32 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
6 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
14 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
9 month · "A little positive", "Somewhat positive", or "Very positive"
38 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
9 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
7 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
15 month · "A little positive", "Somewhat positive", or "Very positive"
28 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
15 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
11 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
18 month · "A little positive", "Somewhat positive", or "Very positive"
30 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
18 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
9 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
21 month · "A little positive", "Somewhat positive", or "Very positive"
36 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
21 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
7 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
24 month · "A little positive", "Somewhat positive", or "Very positive"
36 Participants
Change in Perceived Benefits to Attend School: Positive for Staff
24 month · "Very negative", "Somewhat negative", or "A little negative", "Neutral"
9 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Perceived Benefits to Attend School: Keep Jobs
21 month · Yes
29 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
21 month · No
14 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
24 month · Yes
28 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
24 month · No
17 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
Baseline · Yes
32 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
Baseline · No
19 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
3 month · Yes
29 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
3 month · No
19 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
6 month · Yes
26 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
6 month · No
20 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
9 month · Yes
24 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
9 month · No
21 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
15 month · Yes
22 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
15 month · No
17 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
18 month · Yes
25 Participants
Change in Perceived Benefits to Attend School: Keep Jobs
18 month · No
14 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Number of People
Baseline · "Very" or "Extremely" comfortable
21 Participants
Change in Barriers to School Attendance: Number of People
Baseline · "Not at all", "A little", or "Somewhat" comfortable
30 Participants
Change in Barriers to School Attendance: Number of People
3 month · "Very" or "Extremely" comfortable
14 Participants
Change in Barriers to School Attendance: Number of People
3 month · "Not at all", "A little", or "Somewhat" comfortable
34 Participants
Change in Barriers to School Attendance: Number of People
6 month · "Very" or "Extremely" comfortable
17 Participants
Change in Barriers to School Attendance: Number of People
6 month · "Not at all", "A little", or "Somewhat" comfortable
29 Participants
Change in Barriers to School Attendance: Number of People
9 month · "Very" or "Extremely" comfortable
19 Participants
Change in Barriers to School Attendance: Number of People
9 month · "Not at all", "A little", or "Somewhat" comfortable
26 Participants
Change in Barriers to School Attendance: Number of People
15 month · "Very" or "Extremely" comfortable
12 Participants
Change in Barriers to School Attendance: Number of People
15 month · "Not at all", "A little", or "Somewhat" comfortable
27 Participants
Change in Barriers to School Attendance: Number of People
18 month · "Very" or "Extremely" comfortable
14 Participants
Change in Barriers to School Attendance: Number of People
18 month · "Not at all", "A little", or "Somewhat" comfortable
25 Participants
Change in Barriers to School Attendance: Number of People
21 month · "Very" or "Extremely" comfortable
13 Participants
Change in Barriers to School Attendance: Number of People
21 month · "Not at all", "A little", or "Somewhat" comfortable
30 Participants
Change in Barriers to School Attendance: Number of People
24 month · "Very" or "Extremely" comfortable
15 Participants
Change in Barriers to School Attendance: Number of People
24 month · "Not at all", "A little", or "Somewhat" comfortable
30 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Proximity
Baseline · "Very" or "Extremely" comfortable
18 Participants
Change in Barriers to School Attendance: Proximity
Baseline · "Not at all", "A little", or "Somewhat" comfortable
32 Participants
Change in Barriers to School Attendance: Proximity
3 month · "Very" or "Extremely" comfortable
12 Participants
Change in Barriers to School Attendance: Proximity
3 month · "Not at all", "A little", or "Somewhat" comfortable
36 Participants
Change in Barriers to School Attendance: Proximity
6 month · "Very" or "Extremely" comfortable
18 Participants
Change in Barriers to School Attendance: Proximity
6 month · "Not at all", "A little", or "Somewhat" comfortable
28 Participants
Change in Barriers to School Attendance: Proximity
9 month · "Very" or "Extremely" comfortable
17 Participants
Change in Barriers to School Attendance: Proximity
9 month · "Not at all", "A little", or "Somewhat" comfortable
28 Participants
Change in Barriers to School Attendance: Proximity
15 month · "Very" or "Extremely" comfortable
11 Participants
Change in Barriers to School Attendance: Proximity
15 month · "Not at all", "A little", or "Somewhat" comfortable
28 Participants
Change in Barriers to School Attendance: Proximity
18 month · "Very" or "Extremely" comfortable
13 Participants
Change in Barriers to School Attendance: Proximity
18 month · "Not at all", "A little", or "Somewhat" comfortable
26 Participants
Change in Barriers to School Attendance: Proximity
21 month · "Very" or "Extremely" comfortable
12 Participants
Change in Barriers to School Attendance: Proximity
21 month · "Not at all", "A little", or "Somewhat" comfortable
31 Participants
Change in Barriers to School Attendance: Proximity
24 month · "Very" or "Extremely" comfortable
18 Participants
Change in Barriers to School Attendance: Proximity
24 month · "Not at all", "A little", or "Somewhat" comfortable
27 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: PPE
Baseline · "Very" or "Extremely" comfortable
24 Participants
Change in Barriers to School Attendance: PPE
Baseline · "Not at all", "A little", or "Somewhat" comfortable
27 Participants
Change in Barriers to School Attendance: PPE
3 month · "Very" or "Extremely" comfortable
20 Participants
Change in Barriers to School Attendance: PPE
3 month · "Not at all", "A little", or "Somewhat" comfortable
28 Participants
Change in Barriers to School Attendance: PPE
6 month · "Very" or "Extremely" comfortable
25 Participants
Change in Barriers to School Attendance: PPE
6 month · "Not at all", "A little", or "Somewhat" comfortable
21 Participants
Change in Barriers to School Attendance: PPE
9 month · "Very" or "Extremely" comfortable
20 Participants
Change in Barriers to School Attendance: PPE
9 month · "Not at all", "A little", or "Somewhat" comfortable
25 Participants
Change in Barriers to School Attendance: PPE
15 month · "Very" or "Extremely" comfortable
10 Participants
Change in Barriers to School Attendance: PPE
15 month · "Not at all", "A little", or "Somewhat" comfortable
29 Participants
Change in Barriers to School Attendance: PPE
18 month · "Very" or "Extremely" comfortable
21 Participants
Change in Barriers to School Attendance: PPE
18 month · "Not at all", "A little", or "Somewhat" comfortable
18 Participants
Change in Barriers to School Attendance: PPE
21 month · "Very" or "Extremely" comfortable
19 Participants
Change in Barriers to School Attendance: PPE
21 month · "Not at all", "A little", or "Somewhat" comfortable
24 Participants
Change in Barriers to School Attendance: PPE
24 month · "Very" or "Extremely" comfortable
21 Participants
Change in Barriers to School Attendance: PPE
24 month · "Not at all", "A little", or "Somewhat" comfortable
24 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Testing
Baseline · "Very" or "Extremely" comfortable
11 Participants
Change in Barriers to School Attendance: Testing
Baseline · "Not at all", "A little", or "Somewhat" comfortable
40 Participants
Change in Barriers to School Attendance: Testing
3 month · "Very" or "Extremely" comfortable
14 Participants
Change in Barriers to School Attendance: Testing
3 month · "Not at all", "A little", or "Somewhat" comfortable
34 Participants
Change in Barriers to School Attendance: Testing
6 month · "Very" or "Extremely" comfortable
16 Participants
Change in Barriers to School Attendance: Testing
6 month · "Not at all", "A little", or "Somewhat" comfortable
29 Participants
Change in Barriers to School Attendance: Testing
9 month · "Very" or "Extremely" comfortable
18 Participants
Change in Barriers to School Attendance: Testing
9 month · "Not at all", "A little", or "Somewhat" comfortable
26 Participants
Change in Barriers to School Attendance: Testing
15 month · "Very" or "Extremely" comfortable
10 Participants
Change in Barriers to School Attendance: Testing
15 month · "Not at all", "A little", or "Somewhat" comfortable
29 Participants
Change in Barriers to School Attendance: Testing
18 month · "Very" or "Extremely" comfortable
13 Participants
Change in Barriers to School Attendance: Testing
18 month · "Not at all", "A little", or "Somewhat" comfortable
26 Participants
Change in Barriers to School Attendance: Testing
21 month · "Very" or "Extremely" comfortable
13 Participants
Change in Barriers to School Attendance: Testing
21 month · "Not at all", "A little", or "Somewhat" comfortable
30 Participants
Change in Barriers to School Attendance: Testing
24 month · "Very" or "Extremely" comfortable
15 Participants
Change in Barriers to School Attendance: Testing
24 month · "Not at all", "A little", or "Somewhat" comfortable
30 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Following Recommendations
Baseline · "Very" or "Extremely" comfortable
13 Participants
Change in Barriers to School Attendance: Following Recommendations
Baseline · "Not at all", "A little", or "Somewhat" comfortable
38 Participants
Change in Barriers to School Attendance: Following Recommendations
3 month · "Very" or "Extremely" comfortable
15 Participants
Change in Barriers to School Attendance: Following Recommendations
6 month · "Not at all", "A little", or "Somewhat" comfortable
32 Participants
Change in Barriers to School Attendance: Following Recommendations
9 month · "Very" or "Extremely" comfortable
14 Participants
Change in Barriers to School Attendance: Following Recommendations
9 month · "Not at all", "A little", or "Somewhat" comfortable
31 Participants
Change in Barriers to School Attendance: Following Recommendations
15 month · "Very" or "Extremely" comfortable
9 Participants
Change in Barriers to School Attendance: Following Recommendations
15 month · "Not at all", "A little", or "Somewhat" comfortable
30 Participants
Change in Barriers to School Attendance: Following Recommendations
18 month · "Very" or "Extremely" comfortable
13 Participants
Change in Barriers to School Attendance: Following Recommendations
18 month · "Not at all", "A little", or "Somewhat" comfortable
26 Participants
Change in Barriers to School Attendance: Following Recommendations
21 month · "Very" or "Extremely" comfortable
11 Participants
Change in Barriers to School Attendance: Following Recommendations
21 month · "Not at all", "A little", or "Somewhat" comfortable
32 Participants
Change in Barriers to School Attendance: Following Recommendations
24 month · "Very" or "Extremely" comfortable
14 Participants
Change in Barriers to School Attendance: Following Recommendations
24 month · "Not at all", "A little", or "Somewhat" comfortable
31 Participants
Change in Barriers to School Attendance: Following Recommendations
3 month · "Not at all", "A little", or "Somewhat" comfortable
33 Participants
Change in Barriers to School Attendance: Following Recommendations
6 month · "Very" or "Extremely" comfortable
14 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Transportation
Baseline · "Very" or "Extremely" difficult
5 Participants
Change in Barriers to School Attendance: Transportation
Baseline · "Not at all", "A little", or "Somewhat" difficult
46 Participants
Change in Barriers to School Attendance: Transportation
3 month · "Very" or "Extremely" difficult
1 Participants
Change in Barriers to School Attendance: Transportation
3 month · "Not at all", "A little", or "Somewhat" difficult
47 Participants
Change in Barriers to School Attendance: Transportation
6 month · "Very" or "Extremely" difficult
3 Participants
Change in Barriers to School Attendance: Transportation
6 month · "Not at all", "A little", or "Somewhat" difficult
43 Participants
Change in Barriers to School Attendance: Transportation
9 month · "Very" or "Extremely" difficult
4 Participants
Change in Barriers to School Attendance: Transportation
9 month · "Not at all", "A little", or "Somewhat" difficult
41 Participants
Change in Barriers to School Attendance: Transportation
15 month · "Not at all", "A little", or "Somewhat" difficult
35 Participants
Change in Barriers to School Attendance: Transportation
18 month · "Very" or "Extremely" difficult
2 Participants
Change in Barriers to School Attendance: Transportation
18 month · "Not at all", "A little", or "Somewhat" difficult
35 Participants
Change in Barriers to School Attendance: Transportation
21 month · "Very" or "Extremely" difficult
2 Participants
Change in Barriers to School Attendance: Transportation
21 month · "Not at all", "A little", or "Somewhat" difficult
41 Participants
Change in Barriers to School Attendance: Transportation
24 month · "Very" or "Extremely" difficult
1 Participants
Change in Barriers to School Attendance: Transportation
24 month · "Not at all", "A little", or "Somewhat" difficult
44 Participants
Change in Barriers to School Attendance: Transportation
15 month · "Very" or "Extremely" difficult
4 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Wash
Baseline · "Yes, all of the time" or "Yes, most of the time"
43 Participants
Change in Barriers to School Attendance: Wash
Baseline · "Some of the time", "Rarely", or "Not at all"
8 Participants
Change in Barriers to School Attendance: Wash
3 month · "Yes, all of the time" or "Yes, most of the time"
45 Participants
Change in Barriers to School Attendance: Wash
3 month · "Some of the time", "Rarely", or "Not at all"
3 Participants
Change in Barriers to School Attendance: Wash
6 month · "Yes, all of the time" or "Yes, most of the time"
41 Participants
Change in Barriers to School Attendance: Wash
6 month · "Some of the time", "Rarely", or "Not at all"
5 Participants
Change in Barriers to School Attendance: Wash
9 month · "Yes, all of the time" or "Yes, most of the time"
40 Participants
Change in Barriers to School Attendance: Wash
9 month · "Some of the time", "Rarely", or "Not at all"
5 Participants
Change in Barriers to School Attendance: Wash
15 month · "Yes, all of the time" or "Yes, most of the time"
33 Participants
Change in Barriers to School Attendance: Wash
15 month · "Some of the time", "Rarely", or "Not at all"
6 Participants
Change in Barriers to School Attendance: Wash
18 month · "Yes, all of the time" or "Yes, most of the time"
32 Participants
Change in Barriers to School Attendance: Wash
18 month · "Some of the time", "Rarely", or "Not at all"
7 Participants
Change in Barriers to School Attendance: Wash
21 month · "Yes, all of the time" or "Yes, most of the time"
37 Participants
Change in Barriers to School Attendance: Wash
21 month · "Some of the time", "Rarely", or "Not at all"
6 Participants
Change in Barriers to School Attendance: Wash
24 month · "Yes, all of the time" or "Yes, most of the time"
39 Participants
Change in Barriers to School Attendance: Wash
24 month · "Some of the time", "Rarely", or "Not at all"
6 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Close Contact
Baseline · "Yes, all of the time" or "Yes, most of the time"
47 Participants
Change in Barriers to School Attendance: Close Contact
Baseline · "Some of the time", "Rarely", or "Not at all"
4 Participants
Change in Barriers to School Attendance: Close Contact
3 month · "Yes, all of the time" or "Yes, most of the time"
42 Participants
Change in Barriers to School Attendance: Close Contact
3 month · "Some of the time", "Rarely", or "Not at all"
6 Participants
Change in Barriers to School Attendance: Close Contact
6 month · "Yes, all of the time" or "Yes, most of the time"
41 Participants
Change in Barriers to School Attendance: Close Contact
6 month · "Some of the time", "Rarely", or "Not at all"
5 Participants
Change in Barriers to School Attendance: Close Contact
9 month · "Yes, all of the time" or "Yes, most of the time"
44 Participants
Change in Barriers to School Attendance: Close Contact
9 month · "Some of the time", "Rarely", or "Not at all"
1 Participants
Change in Barriers to School Attendance: Close Contact
15 month · "Yes, all of the time" or "Yes, most of the time"
36 Participants
Change in Barriers to School Attendance: Close Contact
15 month · "Some of the time", "Rarely", or "Not at all"
3 Participants
Change in Barriers to School Attendance: Close Contact
18 month · "Yes, all of the time" or "Yes, most of the time"
36 Participants
Change in Barriers to School Attendance: Close Contact
18 month · "Some of the time", "Rarely", or "Not at all"
3 Participants
Change in Barriers to School Attendance: Close Contact
21 month · "Yes, all of the time" or "Yes, most of the time"
40 Participants
Change in Barriers to School Attendance: Close Contact
21 month · "Some of the time", "Rarely", or "Not at all"
3 Participants
Change in Barriers to School Attendance: Close Contact
24 month · "Yes, all of the time" or "Yes, most of the time"
43 Participants
Change in Barriers to School Attendance: Close Contact
24 month · "Some of the time", "Rarely", or "Not at all"
1 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month, 6 month, 9-12 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")

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Barriers to School Attendance: Masking
Baseline · "Yes, all of the time" or "Yes, most of the time"
24 Participants
Change in Barriers to School Attendance: Masking
Baseline · "Some of the time", "Rarely", or "Not at all"
27 Participants
Change in Barriers to School Attendance: Masking
3 month · "Yes, all of the time" or "Yes, most of the time"
23 Participants
Change in Barriers to School Attendance: Masking
3 month · "Some of the time", "Rarely", or "Not at all"
25 Participants
Change in Barriers to School Attendance: Masking
6 month · "Yes, all of the time" or "Yes, most of the time"
21 Participants
Change in Barriers to School Attendance: Masking
6 month · "Some of the time", "Rarely", or "Not at all"
25 Participants
Change in Barriers to School Attendance: Masking
9 month · "Yes, all of the time" or "Yes, most of the time"
19 Participants
Change in Barriers to School Attendance: Masking
9 month · "Some of the time", "Rarely", or "Not at all"
26 Participants
Change in Barriers to School Attendance: Masking
15 month · "Yes, all of the time" or "Yes, most of the time"
18 Participants
Change in Barriers to School Attendance: Masking
15 month · "Some of the time", "Rarely", or "Not at all"
21 Participants
Change in Barriers to School Attendance: Masking
18 month · "Yes, all of the time" or "Yes, most of the time"
16 Participants
Change in Barriers to School Attendance: Masking
18 month · "Some of the time", "Rarely", or "Not at all"
23 Participants
Change in Barriers to School Attendance: Masking
21 month · "Yes, all of the time" or "Yes, most of the time"
14 Participants
Change in Barriers to School Attendance: Masking
21 month · "Some of the time", "Rarely", or "Not at all"
29 Participants
Change in Barriers to School Attendance: Masking
24 month · "Yes, all of the time" or "Yes, most of the time"
16 Participants
Change in Barriers to School Attendance: Masking
24 month · "Some of the time", "Rarely", or "Not at all"
28 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
15-month · No
14 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
18-month · Yes
30 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
18-month · No
9 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
Baseline · Yes
29 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
Baseline · No
22 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
3-month · Yes
31 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
3-month · No
17 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
6-month · Yes
34 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
6-month · No
12 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
9-month · Yes
32 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
9-month · No
13 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
15-month · Yes
25 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
21-month · Yes
33 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
21-month · No
10 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
24-month · Yes
36 Participants
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
24-month · No
8 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
Baseline · Yes
29 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
Baseline · No
22 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
3-month · Yes
35 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
3-month · No
13 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
6-month · Yes
35 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
6-month · No
11 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
9-month · Yes
37 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
9-month · No
8 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
15-month · Yes
32 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
15-month · No
7 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
18-month · Yes
33 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
18-month · No
6 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
21-month · Yes
37 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
21-month · No
6 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
24-month · Yes
38 Participants
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
24-month · No
7 Participants

PRIMARY outcome

Timeframe: baseline, 3 month, 6 month, 9-12 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. 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.

Outcome measures

Outcome measures
Measure
Caregiver of Children With Medical Complexity (CMC)
n=51 Participants
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 Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
Baseline · Yes
14 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
Baseline · No
8 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
3-month · Yes
9 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
3-month · No
4 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
6-month · Yes
8 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
6-month · No
3 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
9-month · Yes
7 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
9-month · No
1 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
15-month · Yes
4 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
15-month · No
3 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
18-month · Yes
3 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
18-month · No
3 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
21-month · Yes
4 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
21-month · No
2 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
24-month · Yes
4 Participants
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
24-month · No
3 Participants

Adverse Events

Children With Medical Complexity (CMC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 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