Reopening Schools Safely and Educating Youth (ROSSEY) COVID-19 Health Disparities Research Study
Study Details
Study Description
Brief Summary
The study has three aims and involves a clustered randomized controlled trial (RCT) where K-8 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 testing program with school stakeholders, parents, and children. Nasal swabs will be collected for the initial pilot study between the months of April-June 2021, with further, separate study goals and procedures occurring after the pilot study ends to align with 2021-2022 school year. After the completion of the pilot study, the study protocol and tools will be optimized to be implemented in the larger cluster RCT in 2021-2022 school year) that will also involve risk communication comic books and videos.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 a school-based COVID-19 testing program and risk communication on student attendance using a cluster randomized controlled trial (RCT) with two intervention arms: current learning model (comparison) and risk communication. Prior to launching Aim 2, a pilot study will be conducted in April - June 2021 with one school to understand the implementation steps and workflow.
Aim 3. Assess implementation outcomes of the testing program with school stakeholders, parents, and children guided by the REAIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Aim 3 will occur after Aim 1 and 2 were completed.
OVERVIEW:
This study incorporates three aims that are meant to help students and school employees to return to school safely by providing health education to families and school staff. The research team aims to understand how to successfully implement a testing program and health education in schools and learn if the testing program and health education can help improve children's attendance, along with families' and school employees' physical and mental well-being. Aim 1 will involve conducting qualitative assessments with school stakeholders, parents and students. Aim 2 will involve a clustered randomized control trial RCT where that evaluates the role of risk communication and novel coronavirus testing in children attending and staff working in public schools in the region. Schools will be randomized to receive the intervention (risk communication) or serve as a comparison or control group (continue the current practice). To prepare for this large trial, the study will institute a pilot study conducting weekly novel coronavirus surveillance testing in one school during April - June 2021 to understand the implementation steps and the workflow of working with schools. The larger RCT trial will be implemented in 15-20 K-8 schools in Fall 2021 - Spring 2022 school year.
For the pilot study, one school will be recruited into the study starting in late April 2021 for an initial period of at least 2 months. Student participants will be recruited through the school and once enrolled, contacted once per week by SMS text message and/or email with a reminder to collect a swab and to report the presence or absence of symptoms, as well as report any exposures or close contacts with someone confirmed to have SARS-CoV-2. The symptom report will prompt the participant or their parent to collect a nasal swab and return the kit to a designated drop-off location within a specific time frame, or to have the self-collected swab kit picked up from their home and delivered to the laboratory if they are home sick. Parents who choose to have their child swabbed by trained research staff at school will receive a notification once their child has been swabbed, with the information they will need to access their child's test results in the online portal. If participants report symptoms during the weekly check-in, this information will be collected in a brief questionnaire to record those symptoms. Participants between 13 and 15 years of age may collect their own swab with supervision from an adult. For participants 7-13 years old, a parent or legal guardian will assist in completion of the questionnaire, nasal swab collection and drop-off.
Participants will additionally receive risk mitigation communications as part of this intervention. This involves books and videos, (comic books for children) that are provided to educate enrolled parents and their children about COVID-19 and health and safety measures that can help reduce transmission.
STUDY POPULATION: Students and staff members at participating schools in an agricultural region of Washington state.
STUDY TIME PERIOD: A pilot study will be conducted between April-June 2021, with the larger study continuing in August 2021-June 2022. Aim 3 will occur after June 2022.
STATISTICAL ANALYSES: The primary analysis will be based on the average number of onsite learning hours per week over the study period for each student. The data will be analyzed using a linear mixed effects model with district and randomization arm as fixed effects, and school and classroom within school as random effects. Analyses will test for any difference between the randomization arms using α = 0.05 and report the comparisons between arms.
STUDY OUTCOMES:
The primary outcome for children will be absenteeism (hours per week missing onsite learning).
The secondary outcome will be assessed in parent dyads. Parents will share their child's physical activity and emotional regulation; and will be assessed for perceived stress, COVID-related stress, and depressive symptomatology for parents. The secondary outcome will also be assessed among teachers for perceived stress, COVID-19 related stress and depressive symptomatology.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Group This arm will include schools and the enrolled families assigned as the control group, who will not receive the COVID-19 Health Education Comic Books and video intervention until the end of the school year. |
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| Active Comparator: COVID-19 Comic Books This arm will include schools that are randomized to receive an intervention of Health Education comic books focused on the benefits of COVID-19 topics such as masking, social distancing and COVID-19 testing. |
Behavioral: COVID-19 Health Education Comic Books and Videos
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
|
Outcome Measures
Primary Outcome Measures
- School absenteeism [Up to nine months]
How many days of school do participating staff and students miss due to symptoms of respiratory illness
Secondary Outcome Measures
- Emotional regulation of children [Up to once per month over a nine month period]
Children will be assessed for physical activity levels and emotional regulation using qualitative one-on-one interviews and focus groups with their parents enrolled in the study.
- Perceived stress of parents and staff [Up to once per month over a nine month period]
Parents of enrolled children and enrolled staff members will be assessed for perceived stress using a combination of qualitative one-on-one interviews and focus groups over the course of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant attends or works in a participating school for at least 2 days/week.
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Participant must be willing to comply with all study procedures, including weekly online check-ins and phone interviews.
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Participant should have consistent and reliable Internet access, either by smart phone or computer.
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Participant must be comfortable speaking English or Spanish.
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Participant must be able to provide online informed consent and/or legal guardian assent.
Exclusion Criteria:
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Individuals unable to provide informed consent / assent, except in cases where the participant has an available legal authorized representative and/or parent
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Individuals who are incarcerated
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Individuals with conditions that may preclude or limit the participant's ability to comply with study procedures, according to the investigators
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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.
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.- STUDY00013064
- 1OT2HD107544-01