N/A
N=1,143
Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Covid19 · Intellectual Disability · Developmental Disability · Child Development Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04565509 ↗Enrolled (actual)
1,143
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Enrollment Into Weekly Testing by Each Participant - Special School District — 0.47; 0.49 % of participants enrolled per week — p=>0.99
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Messaging (Behavioral); Enhanced Messaging (Behavioral); COVID-19 Testing (Diagnostic_test); Focus Groups (Behavioral); Fuzzy Cognitive Mapping (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Into Weekly Testing by Each Participant - Special School District |
0.47; 0.49 | >0.99 |
| PRIMARY Overall Testing Rate - Special School District |
0.57; 0.46 | 0.90 |
| PRIMARY Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute |
0.25; 0.36 | >0.99 |
| PRIMARY Overall Testing Rate - Kennedy Krieger Institute |
0.43; 0.63 | 0.71 |
| SECONDARY Key Themes and Subthemes: Perceptions of Returning to In-person Learning |
1; 1; 1; 0; 1; 1 | — |
| SECONDARY Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing |
1; 1; 1; 0; 1; 1 | — |
| SECONDARY Key Themes and Subthemes: Communication (Messages) |
1; 1; 1; 0; 0; 1 | — |
| SECONDARY Key Themes and Subthemes: Communication (Messengers) |
1; 1; 1; 1; 1; 0 | — |
| SECONDARY Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test |
0.75; 0.25; 0.43; 0.58; 0.59; 0.38 | — |
| SECONDARY Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test |
0.31; 0.36; 0.55; 0.62; 0.35; 0.37 | — |
Summary
The primary goal of this project is to identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with intellectual and developmental disabilities (IDD) and their teachers to help ensure a safe school environment. Additionally, we will understand nationally the perceptions of COVID-19 and identify facilitators and barriers to help with the adoption of testing in other parts of the US and the necessary strategies to address other mitigation strategies including vaccination.
Eligibility Criteria
Inclusion Criteria
- Students enrolled in the St. Louis Special School District or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland.
- Teachers/Staff working at the St. Louis Special Schools or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland dedicated to teaching children with IDD.
or
- Parents/ of students, teachers and/or staff employed by the St. Louis Special School District or Kennedy Krieger Institute/Sheppard Pratt schools in Maryland or
- Families, teachers, and staff of the 67 University Centers for Excellence in Developmental Disabilities (UCEDD) which is sponsored by the Association of University Centers for Disability (AUCD).
Exclusion Criteria
- Members of the research team will not be eligible to participate in the focus groups.
Data sourced from ClinicalTrials.gov (NCT04565509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.