NIH RADx Data Hub

Study Information

dbGaP Study Accession: phs003127

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/a4fj-3408

Release Date: 08/29/2023

Updated Date: 04/10/2024

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.

Principal Investigator: Ko, Linda K

Has Data Files: Yes

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

Data Collection Method: Survey

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

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

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

Data Types: Questionnaires/Surveys; Other; Clinical

Data Types, Other: COVID-19 Testing Data

Study Start Date: 04/15/2021

Study End Date: 03/31/2023

Species: Human Data

Estimated Cohort Size: 900

Study Population Focus: School Community Members; Children; Hispanic and Latino; Rural Communities; Lower Socioeconomic Status (SES) Population; Older Adults or Elderly; Adults

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

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

Study Documents

Study Documents Table
Document	Document Name	File Size	Download
Study Documentation	phs003127_Project 77_Protocol.pdf	399.32 KB
README	project77_README.html	281.15 KB

Data Files

Total Files: 6

Data Files: 2

Metadata Files: 2

Dictionary Files: 2

Study Datasets Table
File Name	File Type	File Format(s)	# of Records	# of Variables	Metadata	Dictionary
project77_DATA_transformcopy.csv	Tabular Data - Harmonized	csv	720
project77_DATA_origcopy.csv	Tabular Data - Non-harmonized	csv	720