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Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study

Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05965323
Enrollment
97
Registered
2023-07-28
Start date
2022-09-22
Completion date
2024-12-31
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absenteeism

Keywords

SARS-coV-2, School re-opening, Rural Communities, Early Education - pre School, Risk communication

Brief summary

This is a single arm, pre/post intervention study to a larger trial that will examine the effect of health education with comic books and videos on COVID-19 preventive behaviors (masking, social distancing, testing and vaccine uptake). The participants are students, ages 3-5 years old and their parents.

Detailed description

This is a single arm, pre/post intervention study to a larger trial that will examine the effect of health education with comic books and videos on COVID-19 preventive behaviors (masking, social distancing, testing and vaccine uptake). The participants are students, ages 3-5 years old and their parents. Students will receive the intervention from November 2023 to March 2024.

Interventions

BEHAVIORALHealth Education

Health education with comic books and videos

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Must have a child attending the Early Learning Program in the Yakima School District * Must be able to provide informed consent and legal guardian assent either virtually, on the telephone, or in-person. * Must have a permanent mailing address available for study staff to mail necessary materials OR a working email address. * Must speak English or Spanish.

Exclusion criteria

\- Not in Early Learning program in Yakima School District

Design outcomes

Primary

MeasureTime frameDescription
Wash HandsUp to eleven monthsPercentage of early learning students washing hands for COVID-19
TestingUp to eleven monthsPercentage of early learning students testing for COVID-19
MaskingUp to eleven monthsPercentage of early learning students masking for COVID-19
Hide CoughUp to eleven monthsPercentage of early learning students who hide cough during COVID-19

Countries

United States

Participant flow

Recruitment details

Recruitment of parent, child dyads in Early Learning anxillary study 09/22/2022 through 12/30/2022

Participants by arm

ArmCount
Single Arm Pre and Post Intervention Study
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.
97
Total97

Baseline characteristics

CharacteristicSingle Arm Pre and Post Intervention Study
Age, Customized
Parent
<18 years
0 Participants
Age, Customized
Parent
>65 years
0 Participants
Age, Customized
Parent
Between 18 and 65 years
0 Participants
Age, Customized
Parent
Unknown not reported
48 Participants
Age, Customized
Student
<18 years
49 Participants
Age, Customized
Student
>65 years
0 Participants
Age, Customized
Student
Between 18 and 65 years
0 Participants
Age, Customized
Student
Unknown not reported
0 Participants
Ethnicity (NIH/OMB)
Parent
Hispanic or Latino
34 Participants
Ethnicity (NIH/OMB)
Parent
Not Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Parent
Unknown or Not Reported
6 Participants
Ethnicity (NIH/OMB)
Student
Hispanic or Latino
40 Participants
Ethnicity (NIH/OMB)
Student
Not Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Student
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
Parent
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Parent
Asian
0 Participants
Race (NIH/OMB)
Parent
Black or African American
1 Participants
Race (NIH/OMB)
Parent
More than one race
0 Participants
Race (NIH/OMB)
Parent
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Parent
Unknown or Not Reported
40 Participants
Race (NIH/OMB)
Parent
White
7 Participants
Race (NIH/OMB)
Student
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Student
Asian
0 Participants
Race (NIH/OMB)
Student
Black or African American
1 Participants
Race (NIH/OMB)
Student
More than one race
0 Participants
Race (NIH/OMB)
Student
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Student
Unknown or Not Reported
40 Participants
Race (NIH/OMB)
Student
White
8 Participants
Region of Enrollment
United States
49 Student Participants
Sex/Gender, Customized
Parent
Female
36 Participants
Sex/Gender, Customized
Parent
Male
6 Participants
Sex/Gender, Customized
Parent
Unknown, Not Reported
6 Participants
Sex/Gender, Customized
Student
Female
23 Participants
Sex/Gender, Customized
Student
Male
26 Participants
Sex/Gender, Customized
Student
Unknown, Not Reported
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 49
other
Total, other adverse events
0 / 480 / 49
serious
Total, serious adverse events
0 / 480 / 49

Outcome results

Primary

Hide Cough

Percentage of early learning students who hide cough during COVID-19

Time frame: Up to eleven months

Population: Early Learning Students age 3-5 years old

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Early LearningHide CoughFollow UpMissing6 Participants
Early LearningHide CoughEnrollmentFrequently13 Participants
Early LearningHide CoughEnrollmentSometimes24 Participants
Early LearningHide CoughEnrollmentNever7 Participants
Early LearningHide CoughEnrollmentPrefer not to Answer1 Participants
Early LearningHide CoughEnrollmentMissing4 Participants
Early LearningHide CoughFollow UpFrequently14 Participants
Early LearningHide CoughFollow UpSometimes24 Participants
Early LearningHide CoughFollow UpNever5 Participants
Early LearningHide CoughFollow UpPrefer not to Answer0 Participants
Primary

Masking

Percentage of early learning students masking for COVID-19

Time frame: Up to eleven months

Population: Early Learning Students age 3-5 years old

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Early LearningMaskingEnrollmentFrequently7 Participants
Early LearningMaskingEnrollmentNever21 Participants
Early LearningMaskingEnrollmentSometimes21 Participants
Early LearningMaskingEnrollmentMissing0 Participants
Early LearningMaskingFollow UpFrequently21 Participants
Early LearningMaskingFollow UpNever15 Participants
Early LearningMaskingFollow UpSometimes7 Participants
Early LearningMaskingFollow UpMissing6 Participants
Primary

Testing

Percentage of early learning students testing for COVID-19

Time frame: Up to eleven months

Population: Early Learning Students age 3-5 years old

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Early LearningTestingEnrollmentTest Yes41 Participants
Early LearningTestingEnrollmentTesting No8 Participants
Early LearningTestingEnrollmentPrefer not to Respond0 Participants
Early LearningTestingEnrollmentUnknown Not Reported0 Participants
Early LearningTestingFollow UpTest Yes22 Participants
Early LearningTestingFollow UpTesting No20 Participants
Early LearningTestingFollow UpPrefer not to Respond1 Participants
Early LearningTestingFollow UpUnknown Not Reported6 Participants
Primary

Wash Hands

Percentage of early learning students washing hands for COVID-19

Time frame: Up to eleven months

Population: Early Learning Students age 3-5 years old

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Early LearningWash HandsEnrollmentFrequenty42 Participants
Early LearningWash HandsEnrollmentSometimes7 Participants
Early LearningWash HandsEnrollmentMissing0 Participants
Early LearningWash HandsFollow UpFrequenty35 Participants
Early LearningWash HandsFollow UpSometimes8 Participants
Early LearningWash HandsFollow UpMissing6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026