Reopening Schools Safely and Educating Youth Research Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 1,095
- Locations
- 1
- Primary Endpoint
- School Attendance
Study Overview
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.
Detailed Description
OBJECTIVE:
Aim 1. Identify the rural Latino community's social, ethical, behavioral needs and resources for students to return to school and maintain onsite learning using qualitative assessments with school stakeholders, parents, and students.
Aim 2. Evaluate the effectiveness of risk communication on student attendance and participation in SARS-CoV-2 testing using a cluster randomized controlled trial (RCT) with two intervention arms: intervention (SARS-CoV-2 Risk Communication) and comparison (control group) arm.
Aim 3. Assess implementation outcomes of the Yakima School District testing program and risk communication intervention with school stakeholders, parents, and children guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework.
OVERVIEW:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Control Group
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
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.
Intervention: COVID-19 Health Education Comic Books and Videos (Behavioral)
Outcomes
Primary Outcomes
School Attendance
Time Frame: Up to nine months
How many school days missed due to symptoms of respiratory illness (only include index child).
Secondary Outcomes
- 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))
Investigators
Linda Ko
Professor, School of Public Health
University of Washington