NCT05965323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 8, 2025

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

July 19, 2023

Results QC Date

April 3, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

SARS-coV-2School re-openingRural CommunitiesEarly Education - pre SchoolRisk communication

Outcome Measures

Primary Outcomes (4)

  • Testing

    Percentage of early learning students testing for COVID-19

    Up to eleven months

  • Masking

    Percentage of early learning students masking for COVID-19

    Up to eleven months

  • Wash Hands

    Percentage of early learning students washing hands for COVID-19

    Up to eleven months

  • Hide Cough

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

    Up to eleven months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Health education with comic books and videos

Intervention

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Not in Early Learning program in Yakima School District

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

Results Point of Contact

Title
Linda K Ko, PhD, Principal Investigator
Organization
University of Washington

Study Officials

  • Linda Ko, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Public Health

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 28, 2023

Study Start

September 22, 2022

Primary Completion

May 8, 2024

Study Completion

December 31, 2024

Last Updated

June 8, 2025

Results First Posted

June 8, 2025

Record last verified: 2025-05

Locations