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Clinical Trial 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. Exposed contacts of individuals with novel coronavirus infection in the household or classroom will be offered enrollment into the study as secondary participants, which will entail weekly swabbing for two weeks after secondary enrollment. 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.


Clinical Trial 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 testing program (novel coronavirus testing and risk communication) on student attendance using a cluster randomized controlled trial (RCT) with two intervention arms: current learning model (comparison) and testing program (novel coronavirus testing + 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 free coronavirus testing and health education to families and school staff. The research team aims to understand how to successfully implement the 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 (novel coronavirustesting and 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. If a positive case is identified among the participants, close classroom contacts (children and/or other staff) and households with potential exposure to the positive case will have the opportunity to enroll in the study as a secondary participant. After consent, these secondary participants will be contacted twice (over two weeks) by SMS text message and/or email with a reminder to report the presence or absence of symptoms. This report will prompt the secondary participant to collect a nasal swab and return it within a specific time frame. 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. Teachers and school administrators will also be invited to participate in the weekly testing program. Participants will additionally receive risk mitigation communications as part of this intervention. This involves books, (comic books for children) that are provided to educate them about COVID and health and safety measures 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 child-parent dyads. Children will be assessed for physical activity and emotional regulation; parents 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


Related Conditions & MeSH terms


NCT number NCT04859699
Study type Interventional
Source University of Washington
Contact Amanda T Parrish
Phone 206-685-4353
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date April 2021
Completion date June 2023

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