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

June 5, 2025 updated by: Linda Ko, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19
Behavioral: Health Education
Health education with comic books and videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing
Time Frame: Up to eleven months
Percentage of early learning students testing for COVID-19
Up to eleven months
Masking
Time Frame: Up to eleven months
Percentage of early learning students masking for COVID-19
Up to eleven months
Wash Hands
Time Frame: Up to eleven months
Percentage of early learning students washing hands for COVID-19
Up to eleven months
Hide Cough
Time Frame: Up to eleven months
Percentage of early learning students who hide cough during COVID-19
Up to eleven months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Linda Ko, PhD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Actual)

May 8, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00014531-B
  • 1OT2HD107544-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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