dbGaP Study Accession: phs003127

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

Release Date: 08/29/2023

DOI: 10.60773/a4fj-3408

Study Description: While public health measures with school closure helped mitigate the spread of COVID-19, Latino children from rural agricultural communities are experiencing learning gaps due to disproportionate access to resources. Analyzing data collected from SARS-CoV-2 test results of students returning to in-person learning in the Yakima School District, combined with risk communication, may provide a mechanism to identify outbreaks early and stop transmission, as well as provide reassurance to families and to staff about the safety of on-site instruction. Risk communication was used as a tool to educate the community on the benefits of the testing program, while addressing social, behavioral, and ethical concerns for testing and vaccine hesitancy to prepare them for vaccine readiness. The study had three aims and involved a clustered randomized controlled trial (RCT) where K-5 elementary schools were the unit of randomization. The study collaborated with Yakima School District in the Yakima area and planned to enroll at least 900 participants. 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 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 was conducted in April-June 2021 with one school to understand the implementation steps and workflow. The larger RCT trial was implemented in 14 elementary schools in Fall 2021-Spring 2022 school year. Schools were randomized to receive the intervention (risk communication) or serve as a comparison or control group (continue the current practice). Participants in the intervention group received comic books once every three months. Participants randomly selected into the control group were given comic books at the end of the study. Parents of participants randomized to the Intervention group were given two health educational videos focused on COVID-19 throughout the school year. Caregivers of participants randomized to the control group received the two videos at the end of the study period. Primary outcomes for children were absenteeism (hours per week missing onsite learning). Secondary outcomes were assessed via surveys with 300 parents, with 150 parents of children from the control and 150 parents of children from the intervention group. Parents were asked about their children's physical activity and emotional regulation; parents were assessed for their perceived stress, COVID-related stress, and depressive symptomatology. Secondary outcome survey assessments were optional and offered to participants to be completed at time of enrollment, halfway through the study, and towards the end of the school year. Parents were provided the option to have their children enrolled in the Yakima School District's weekly SARS-CoV-2 testing program, separate from the study. There wase a Data Use Agreement (DTUA) with the Yakima School District's approval to access the SARS-CoV-2 test results of students enrolled in the research study. Access to student test information and results allowed the team to observe the effect that participation in weekly COVID-19 testing had on the primary and secondary outcomes that were assessed in this study. Aim 3. Assess implementation outcomes of the program with school stakeholders, parents, and children guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Aim 3 occurred after Aim 1 and 2 were completed.

Updated Date: 04/10/2024

Principal Investigator: Ko, Linda K

Has Data Files: Yes

Study Domain: COVID in School Settings; Mental Health; Testing Rate or Uptake; Vaccination Rate or Uptake; Virological Testing

Data Collection Method: Survey

Keywords: COVID Education; COVID Risk Mitigation; Families of School-aged Children/Young Adults; Return-to-Inperson Learning; School Staff/Stakeholders; Student Attendance

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

Study Sites: University of Washington; Fred Hutchinson Cancer Research Center

Data Types: Clinical; Immunological; Questionnaire or Survey

Study Start Date: 04/15/2021

Study End Date: 03/31/2023

Species: Human

Sample Size: 720

Study Population Focus: Adults; Children; Hispanics or Latinos; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Rural Communities; School Communities

ClinicalTrials.gov URL: https://www.clinicaltrials.gov/study/NCT04859699

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737177/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737179/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737181/; https://pubmed.ncbi.nlm.nih.gov/35260896/; https://pubmed.ncbi.nlm.nih.gov/37394502/; https://pubmed.ncbi.nlm.nih.gov/37394502/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394512/

Acknowledgement Statement: This study was supported through funding, 3OT2HD107544-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. Approved users should acknowledge the provision of data access by dbGaP for accession phs003127.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

NIH Grant or Contract Number(s): 3OT2HD107544-01S1

Consent/Data Use Limitations: General Research Use