dbGaP Study Accession: phs002904

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/61bs-2j03

Study Description: The study objective was to increase safe return to school for CMC (children with medical complexity) and school personnel through 3 complementary approaches/aims. Aim 1 proposed to determine the feasibility of in-home and school-based testing strategies for CMC, as well as to gain understanding of parent perceptions about in-person school attendance. Activities in this aim involved 3 cohorts: Cohort 1 were caregivers and CMC enrolled in a complex care program. Subjects were offered in-home testing kits and asked to complete quarterly surveys on parent perceptions of safe school attendance during the pandemic. Cohort 2 involved students and staff of a preschool providing care to typically developing and special needs students. Subjects were offered in-school and in-home testing, and were asked to complete the quarterly surveys. Cohort 3 involved students enrolled at a K-12 school exclusively serving children with special needs. Parents were asked to complete the quarterly surveys and may have also opted to share their child's COVID testing results performed at the school. Aim 2 attempted to broaden understanding of parent perceptions predicting school attendance by soliciting parents of CMC receiving care at a large academic medical center to complete the quarterly survey on perceptions of safe school attendance during the pandemic. Aim 3 was to establish a consensus set of stakeholder priorities to facilitate safe school attendance for CMC.

Updated Date: 04/17/2024

Principal Investigator: Coller, Ryan J

Has Data Files: Yes

Study Domain: Rapid Diagnostic Test (RDT); Self-Testing (At-Home or OTC); COVID in School Settings; Pandemic Perceptions and Decision-Making; Diagnostic Testing

Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device; Antigen Testing Device; Survey

Keywords: Return to In-person Learning; Children with Medical Complexity; School-based Testing; School-aged Children/Young Adults; School Staff/Stakeholders; Families/Legal Guardians of School-aged Children/Young Adults; School Attendance Rates

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Other; Clinical; Questionnaires/Surveys

Data Types, Other: Testing results from COVID rapid antigen and PCR tests

Study Start Date: 04/28/2021

Study End Date: 03/31/2023

Species: Human Data

Estimated Cohort Size: 3000

Study Population Focus: Children; School Community Members; Adults; Intellectual and Developmental Disabilities; Underserved/Vulnerable Population

Study Website URL: https://www.reset4kids.org/

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04895085; https://clinicaltrials.gov/study/NCT04899245

Publication URL: https://pubmed.ncbi.nlm.nih.gov/36076181/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394506/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9452877/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647557/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647738/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647774/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647777/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647778/; https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737177/; 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/34737181/; https://pubmed.ncbi.nlm.nih.gov/34873629/; https://pubmed.ncbi.nlm.nih.gov/35260896/; https://pubmed.ncbi.nlm.nih.gov/36108256/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394506/; https://pubmed.ncbi.nlm.nih.gov/37394512/

Acknowledgement Statement: This study was supported through funding, 3OT2HD107558-01S1, 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 phs002904.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): 3OT2HD107558-01S1

Consent/Data Use Limitations: General Research Use