Reopening Schools Safely and Educating Youth Research Study (ROSSEY)

NCT04859699 | Completed Results

• 2 other identifiers: STUDY00014531-A1OT2HD107544-01
• Study Type: interventional
• Target: 1,095
• Locations: 1 country
• Sites: 1

Brief Summary

The study has three aims and involves a clustered randomized controlled trial (RCT) where K-5 schools will be the unit of randomization. Aim 1 involves a qualitative assessment of rural Latino community's social, ethical, behavioral needs and resources for students to return to school and maintain onsite learning. Aim 2 includes a clustered RCT in schools. Aim 3 involves qualitative assessment of implementation outcomes of the Yakima School District (YSD) testing program and risk communication intervention with school stakeholders, parents, and children.

Conditions

Absenteeism

Keywords

SARS-CoV-2; School re-opening; Rural communities; Risk communication

Outcome Measures

Primary Outcomes (1)

• School Attendance

  How many school days missed due to symptoms of respiratory illness (only include index child).

  Up to nine months

Secondary Outcomes (4)

• Emotional Regulation of Index Children at Baseline (T1)

  Completed at baseline (T1)

• Perceived Stress of Parents at Baseline (T1)

  Completed at baseline (T1)

• Emotional Regulation of Index Children at Post Survey 1 (T2)

  Post survey 1 (T2)

• Perceived Stress of Parents at Post Survey 1 (T2)

  Completed at Post survey 1 (T2)

Study Arms (2)

Control Group

NO INTERVENTION

This arm will include schools(n=7) and the enrolled families from those schools assigned as the control group, who will not receive the COVID-19 health education comic books and video intervention.

COVID-19 Comic Books and Videos

ACTIVE COMPARATOR

This arm will include schools (n=7) and enrolled families from those schools that are randomized to receive the health education with comic books and videos focused on the benefits of preventive measures for COVID-19.

Behavioral: COVID-19 Health Education Comic Books and Videos

Interventions

COVID-19 Health Education Comic Books and Videos BEHAVIORAL

Comic books and videos will be shared with intervention students and their parents to provide education on COVID-19 topics such as masking, social distancing and COVID-19 testing

COVID-19 Comic Books and Videos

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant attends or works in a participating school for at least 2 days/week.
• Participant must be willing to comply with all study procedures, including weekly online check-ins and phone interviews.
• Participant should have consistent and reliable Internet access, either by smart phone or computer.
• Participant must be comfortable speaking English or Spanish.
• Participant must be able to provide online informed consent and/or legal guardian assent.

You may not qualify if:

• Individuals unable to provide informed consent / assent, except in cases where the participant has an available legal authorized representative and/or parent
• Individuals who are incarcerated
• Individuals with conditions that may preclude or limit the participant's ability to comply with study procedures, according to the investigators
• Children who are wards of the state and who have clinically-diagnosed dementia, terminal (\<5 years) illness, major psychiatric illness, severe hearing impairment, and inability to move, which will be assessed during the distribution of the study recruitment packets to families.

Sponsors & Collaborators

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

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (3)

• Pascoe KM, Bishop S, Ci X, Ramirez M, Perez G, Ibarra G, Garza L, Linde S, Duran MC, Chae HY, Quigley T, Hassell L, Garrison MM, Drain PK, Shah PD, Ko LK. Factors that shape COVID-19 pediatric vaccine decision-making in rural agricultural communities: A qualitative study. Vaccine. 2024 Dec 2;42(26):126389. doi: 10.1016/j.vaccine.2024.126389. Epub 2024 Oct 4.

  PMID: 39368130 DERIVED

• Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

  PMID: 38597249 DERIVED

• Ramirez M, Shah PD, Chu HY, Garza L, Linde S, Garrison MM, Zhou C, Bishop S, Ibarra G, Ko LK. Reopening schools safely and educating youth (ROSSEY) study: Protocol for a community-based, cluster randomized controlled trial. Contemp Clin Trials. 2024 Apr;139:107480. doi: 10.1016/j.cct.2024.107480. Epub 2024 Feb 19.

  PMID: 38382823 DERIVED

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Results Point of Contact

• Title: Linda K. Ko
• Organization: University of Washington

lindako@uw.edu

+1 206 707-5624

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: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Public Health

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: January 17, 2022
• Primary Completion: May 8, 2024
• Study Completion: December 31, 2024
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Locations

US (1)