dbGaP Study Accession: phs003359

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

Release Date: 12/06/2023

DOI: 10.60773/yry0-5j59

Updated Date: 04/17/2024

Study Description: Children with intellectual and developmental disabilities (IDD) are at major risk of irreversible harm from the Coronavirus Infectious Diseases 2019 (COVID-19) pandemic, particularly those from underserved populations. Not only are they at dramatically higher risk of becoming infected with Severe Acute Respiratory SyndromeCoronavirus-2 (SARS-CoV-2) and death from COVID-19, but children with IDD are vulnerable to the negative impact of school closure. School districts provide critical services beyond the education, including nutritional, social, therapy (physical, occupational, and speech-language) and healthcare services. Risks are heightened for children with IDD, as they are often unable to wear masks, practice social distancing and/or implement effective hand hygiene. Access to rapid and reliable SARS-CoV-2 testing is essential for children with IDD and school staff in order to safely return to school. Members of the research team have developed an innovative, scalable, low-cost method for SARS-CoV-2 testing using saliva samples. Investigators at the Washington University Intellectual and Developmental Disabilities Research Center (IDDRC@WUSTL), in collaboration with the University of Missouri-Kansas City Institute of Human Development and the Kennedy Krieger Institute in Maryland (which includes an IDDRC, the Maryland Center for Developmental Disabilities, and the Kennedy Krieger School Programs), are ideally positioned to determine the best implementation strategies to maximize use of a saliva-based SARS-CoV-2 diagnostic test for vulnerable children and school staff in a school setting. The IDDRC@WUSTL has a long-standing relationship with the Special School District (SSD) of St. Louis County, whose mission is to serve children with IDD, and the national network of the Association of University Centers on Disabilities (AUCD). First, the most effective messaging and implementation strategies to maximize weekly SARS-CoV-2 testing in a school setting were determined. In this adaptive clinical trial, 52,000 diagnostic tests to students and school staff at SSD, whose student population is 48% Black were administered. Second, the study measured national attitudes among parents/guardians of children with IDD and school staff regarding the impact of COVID-19 and the importance of SARS-CoV-2 testing. At the successful completion of this project, the study improved the acceptance, adoption, and process for SARS-CoV-2 diagnostic testing in a school-based setting to enable delivery of critical educational activities for children with IDD in an underserved community. By identifying the most effective methods for SARS-CoV-2 testing in a vulnerable population of children with IDD, the study established a blueprint for wider adoption of COVID-19 mitigation efforts, such as vaccination.

Principal Investigator: Newland, Jason

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; COVID in School Settings; Rapid Diagnostic Test (RDT); Social Determinants of Health

Data Collection Method: Survey

Keywords: School-aged Children/Young Adults; Migrant Populations; Students; Families of School-aged Children/Young Adults; School Staff

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: Hugo W Moser Research Institute at Kennedy Krieger; Inc; Johns Hopkins Bloomberg School of Public Health; University of Missouri - Kansas City; and Johns Hopkins University School of Medicine

Data Types: Questionnaires/Surveys

Study Start Date: 07/28/2020

Study End Date: 05/31/2025

Species: Human Data

Estimated Cohort Size: 6200

Study Population Focus: Asian; Older Adults or Elderly; Adults; Hispanic and Latino; School Community Members; Underserved/Vulnerable Population; Racial and Ethnic Minorities; African American; Children; Intellectual and Developmental Disabilities

ClinicalTrials.gov URL: https://www.clinicaltrials.gov/study/NCT04565509

Publication URL: https://pubmed.ncbi.nlm.nih.gov/37127524/; https://pubmed.ncbi.nlm.nih.gov/36446054/; https://pubmed.ncbi.nlm.nih.gov/33597139/

Acknowledgement Statement: This study was supported through funding, 3P50HD103525-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We want to acknowledge the community who has partnered with us on this work through engagement in so many different ways. We also want to acknowledge the team working to implement and execute this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs003359.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.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3P50HD103525-01S1

Consent/Data Use Limitations: General Research Use