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: At-Home or Over-the-Counter (OTC) Self-Testing; COVID in School Settings; Diagnostic Testing; Pandemic Perceptions or Decision-Making; Rapid Diagnostic Test (RDT)
Data Collection Method: Antigen Testing Device; Molecular Nucleic Acid or PCR Testing Device; Survey
Keywords: Children with Medical Complexity; Families/Legal Guardians of School-aged Children/Young Adults; Return to In-person Learning; School Attendance Rates; School Staff/Stakeholders; School-aged Children/Young Adults; School-based Testing
Study Design: Longitudinal Cohort
Multi-Center Study: No
Data Types: Biological Specimens; Clinical; Immunological; Questionnaire or Survey
Study Start Date: 04/28/2021
Study End Date: 03/31/2023
Species: Human Data
Estimated Cohort Size: 3000
Study Population Focus: Adults; Children; Intellectual or Developmental Disabilities; School Communities; Underserved or Vulnerable Populations
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/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/36076181/; https://pubmed.ncbi.nlm.nih.gov/36108256/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394506/; https://pubmed.ncbi.nlm.nih.gov/37394506/; https://pubmed.ncbi.nlm.nih.gov/37394512/; 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/
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