Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT04565509
- Status
- Completed
Conditions
- Child Development Disorder
- Covid19
- Developmental Disability
- Intellectual Disability
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 90 Years
- Healthy Volunteers
- Accepted
Interventions
- Standard Messaging — BEHAVIORALA messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
- Enhanced Messaging — BEHAVIORALA messaging strategy that is developed from focus groups that is targeted to address specific concerns of the different communities. Messages may target groups being tested (staff versus students) or sociodemographic or race/ethnicity differences between schools depending on the focus groups input.
- COVID-19 Testing — DIAGNOSTIC_TESTWeekly surveillance COVID-19 testing.
- Focus Groups — BEHAVIORALFocus groups to develop enhanced messaging.
- Fuzzy Cognitive Mapping — BEHAVIORALFCMs to assess facilitators and barriers to COVID-19 testing.
Study Details
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.
Key Dates
- Start date
- Nov 20, 2020
- Status verified
- Jan 2026
- Primary completion
- Mar 29, 2024
- Completion
- Mar 29, 2024
Study Design
- Enrollment
- 1,143 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: SSD: Standard Messaging - Standard MessagingIn phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
- Active Comparator: SSD: Standard Messaging - Enhanced MessagingIn phase 1, all schools received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
- Active Comparator: KKI: Standard Messaging - Standard MessagingIn phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.
- Active Comparator: KKI: Standard Messaging - Enhanced MessagingIn phase 1, all schools received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
- Experimental: Focus GroupsFocus group were completed in Phase 1 to develop enhanced messaging. Focus group participants were not required to be enrolled in testing.
- Experimental: Fuzzy Cognitive MappingFCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing.
Primary Outcome Measure
Enrollment Into Weekly Testing by Each Participant - Special School District [ Time Frame: 22 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland | 21205 | - |
| University of Missouri | Kansas City | Missouri | 64110 | - |
| Special School District | St Louis | Missouri | 63131 | - |
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