Trial Outcomes & Findings for Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study (NCT NCT05965323)
NCT ID: NCT05965323
Last Updated: 2025-06-08
Results Overview
Percentage of early learning students testing for COVID-19
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
Up to eleven months
Results posted on
2025-06-08
Participant Flow
Recruitment of parent, child dyads in Early Learning anxillary study 09/22/2022 through 12/30/2022
Participant milestones
| Measure |
Students
Assented students enrolled in Early Learning study
|
Parent
Consented parents of Early Learning Students
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
Baseline characteristics by cohort
| Measure |
Single Arm Pre and Post Intervention Study
n=97 Participants
We want to learn if health education (COVID-19 Health Education Comic Books and Videos) can increase the uptake of COVID-19 mitigation measures, improve children's school attendance, and increase families' physical and mental well-being using single-arm pre/post-study.
|
|---|---|
|
Age, Customized
Student · <18 years
|
49 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Student · Between 18 and 65 years
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Student · >65 years
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Student · Unknown not reported
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Parent · <18 years
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Parent · Between 18 and 65 years
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Parent · >65 years
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Age, Customized
Parent · Unknown not reported
|
48 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Sex/Gender, Customized
Student · Female
|
23 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Sex/Gender, Customized
Student · Male
|
26 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Sex/Gender, Customized
Student · Unknown, Not Reported
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Sex/Gender, Customized
Parent · Female
|
36 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Sex/Gender, Customized
Parent · Male
|
6 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Sex/Gender, Customized
Parent · Unknown, Not Reported
|
6 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Ethnicity (NIH/OMB)
Student · Hispanic or Latino
|
40 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Ethnicity (NIH/OMB)
Student · Not Hispanic or Latino
|
8 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Ethnicity (NIH/OMB)
Student · Unknown or Not Reported
|
1 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
34 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
8 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
6 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · American Indian or Alaska Native
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · Asian
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · Black or African American
|
1 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · White
|
8 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · More than one race
|
0 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Student · Unknown or Not Reported
|
40 Participants
n=49 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · American Indian or Alaska Native
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · Asian
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · Black or African American
|
1 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · White
|
7 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · More than one race
|
0 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Race (NIH/OMB)
Parent · Unknown or Not Reported
|
40 Participants
n=48 Participants • Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants
|
|
Region of Enrollment
United States
|
48 Parent Participants
n=97 Participants
|
PRIMARY outcome
Timeframe: Up to eleven monthsPopulation: Early Learning Students age 3-5 years old
Percentage of early learning students testing for COVID-19
Outcome measures
| Measure |
Early Learning
n=49 Participants
The students will receive comic books and their parents videos on the benefits of preventive measures of COVID-19
Health Education: Health education with comic books and videos
|
|---|---|
|
Testing
Enrollment · Test Yes
|
41 Participants
|
|
Testing
Enrollment · Testing No
|
8 Participants
|
|
Testing
Enrollment · Prefer not to Respond
|
0 Participants
|
|
Testing
Enrollment · Unknown Not Reported
|
0 Participants
|
|
Testing
Follow Up · Test Yes
|
22 Participants
|
|
Testing
Follow Up · Testing No
|
20 Participants
|
|
Testing
Follow Up · Prefer not to Respond
|
1 Participants
|
|
Testing
Follow Up · Unknown Not Reported
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to eleven monthsPopulation: Early Learning Students age 3-5 years old
Percentage of early learning students masking for COVID-19
Outcome measures
| Measure |
Early Learning
n=49 Participants
The students will receive comic books and their parents videos on the benefits of preventive measures of COVID-19
Health Education: Health education with comic books and videos
|
|---|---|
|
Masking
Enrollment · Frequently
|
7 Participants
|
|
Masking
Enrollment · Never
|
21 Participants
|
|
Masking
Enrollment · Sometimes
|
21 Participants
|
|
Masking
Enrollment · Missing
|
0 Participants
|
|
Masking
Follow Up · Frequently
|
21 Participants
|
|
Masking
Follow Up · Never
|
15 Participants
|
|
Masking
Follow Up · Sometimes
|
7 Participants
|
|
Masking
Follow Up · Missing
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to eleven monthsPopulation: Early Learning Students age 3-5 years old
Percentage of early learning students washing hands for COVID-19
Outcome measures
| Measure |
Early Learning
n=49 Participants
The students will receive comic books and their parents videos on the benefits of preventive measures of COVID-19
Health Education: Health education with comic books and videos
|
|---|---|
|
Wash Hands
Enrollment · Frequenty
|
42 Participants
|
|
Wash Hands
Enrollment · Sometimes
|
7 Participants
|
|
Wash Hands
Enrollment · Missing
|
0 Participants
|
|
Wash Hands
Follow Up · Frequenty
|
35 Participants
|
|
Wash Hands
Follow Up · Sometimes
|
8 Participants
|
|
Wash Hands
Follow Up · Missing
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to eleven monthsPopulation: Early Learning Students age 3-5 years old
Percentage of early learning students who hide cough during COVID-19
Outcome measures
| Measure |
Early Learning
n=49 Participants
The students will receive comic books and their parents videos on the benefits of preventive measures of COVID-19
Health Education: Health education with comic books and videos
|
|---|---|
|
Hide Cough
Enrollment · Frequently
|
13 Participants
|
|
Hide Cough
Enrollment · Sometimes
|
24 Participants
|
|
Hide Cough
Enrollment · Never
|
7 Participants
|
|
Hide Cough
Enrollment · Prefer not to Answer
|
1 Participants
|
|
Hide Cough
Enrollment · Missing
|
4 Participants
|
|
Hide Cough
Follow Up · Frequently
|
14 Participants
|
|
Hide Cough
Follow Up · Sometimes
|
24 Participants
|
|
Hide Cough
Follow Up · Never
|
5 Participants
|
|
Hide Cough
Follow Up · Prefer not to Answer
|
0 Participants
|
|
Hide Cough
Follow Up · Missing
|
6 Participants
|
Adverse Events
Single Arm Pre and Post Intervention Study - Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Arm Pre and Post Intervention Study - Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Linda K Ko, PhD, Principal Investigator
University of Washington
Phone: 2062568261
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place