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 — BEHAVIORAL
    A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
  • Enhanced Messaging — BEHAVIORAL
    A 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_TEST
    Weekly surveillance COVID-19 testing.
  • Focus Groups — BEHAVIORAL
    Focus groups to develop enhanced messaging.
  • Fuzzy Cognitive Mapping — BEHAVIORAL
    FCMs 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 Messaging
    In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
  • Active Comparator: SSD: Standard Messaging - Enhanced Messaging
    In 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 Messaging
    In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.
  • Active Comparator: KKI: Standard Messaging - Enhanced Messaging
    In 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 Groups
    Focus group were completed in Phase 1 to develop enhanced messaging. Focus group participants were not required to be enrolled in testing.
  • Experimental: Fuzzy Cognitive Mapping
    FCMs 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)

FacilityCityStateZIPSite coordinators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.BaltimoreMaryland21205-
University of MissouriKansas CityMissouri64110-
Special School DistrictSt LouisMissouri63131-

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