dbGaP Study Accession: phs002947

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

Release Date: 08/29/2023

DOI: 10.60773/td0b-xf65

Study Description: Underserved populations are at dramatically higher risk of becoming infected with Severe Acute Respiratory Syndrome, Coronavirus-2 (SARS-CoV-2) and death from COVID-19. 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 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), were 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 study determined the most effective messaging and implementation strategies to maximize weekly SARS-CoV-2 testing in a school setting. In this adaptive clinical trial, 52,000 diagnostic tests were administered to students and school staff at SSD, whose student population is 48% Black. 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, this 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.

Updated Date: 04/17/2024

Principal Investigator: Kalb, Luther

Has Data Files: Yes

Study Domain: COVID in School Settings; Diagnostic Testing; Medical Device or Tool Development; Pandemic Perceptions or Decision-Making; Rapid Diagnostic Test (RDT); Testing Rate or Uptake

Data Collection Method: Interview or Focus Group; Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: Children with Intellectual Development Disorders; Families/Legal Guardians of School-aged Children/Young Adults; Risk Mitigation; School Staff/Stakeholders; School-aged Children/Young Adults

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

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: Washington University; St. Louis

Data Types: Behavioral; Questionnaire or Survey; Social

Study Start Date: 04/14/2021

Study End Date: 11/30/2022

Species: Human

Estimated Cohort Size: 350

Study Population Focus: Adults; African Americans; Children; Intellectual or Developmental Disabilities; Older Adults or Elderly; School Communities; Underserved or Vulnerable Populations

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/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394512/

Acknowledgement Statement: This study was supported through funding, 1OT2HD107556-01, 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 advisory committee's at Kennedy Krieger and Washington University who assisted the study team with recruitment and dissemination. Approved users should acknowledge the provision of data access by dbGaP for accession phs002947.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): 1OT2HD107556-01

Consent/Data Use Limitations: General Research Use