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

NCT ID: NCT05965323

Last Updated: 2025-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Absenteeism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

The students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19

Group Type EXPERIMENTAL

Health Education

Intervention Type BEHAVIORAL

Health education with comic books and videos

Interventions

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Health Education

Health education with comic books and videos

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Linda Ko

Professor, School of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Ko, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1OT2HD107544-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00014531-B

Identifier Type: -

Identifier Source: org_study_id

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