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

• Sponsor: University of Washington (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05965323
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Absenteeism	Behavioral: Health Education	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study
• Actual Study Start Date: Jun 13, 2022
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Mar 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. School absenteeism [Up to nine months]

   How many days students miss due to symptoms of respiratory illness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98109

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Linda Ko, Professor, School of Public Health, University of Washington
• ClinicalTrials.gov Identifier: NCT05965323
• Other Study ID Numbers: STUDY00014531-B; 1OT2HD107544-01
• First Posted: Jul 28, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Linda Ko, Professor, School of Public Health, University of Washington: SARS-coV-2; School re-opening; Rural Communities; Early Education - pre School; Risk communication

Study Results

No Results Posted as of Jul 28, 2023