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NCT04565509 · ClinicalTrials.gov registry record · NA
Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
A NA study of COVID-19 and Intellectual Disability, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 1,143
- Enrollment target
- 3
- Study locations
NCT04565509: Completed NA study of COVID-19 and Intellectual Disability, sponsored by Washington University School of Medicine.
NCT04565509 is a NA study of COVID-19 and Intellectual Disability that has completed, run by Washington University School of Medicine. The registered enrollment target is 1,143 participants, below the 38,461-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565509, a NA study of COVID-19 and Intellectual Disability, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,143 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the
Conditions Studied
Interventions
- DIAGNOSTIC_TEST COVID-19 Testing
- BEHAVIORAL Focus Groups
- BEHAVIORAL Standard Messaging
- BEHAVIORAL Enhanced Messaging
- BEHAVIORAL Fuzzy Cognitive Mapping
Study Locations (3)
Missouri
- University of Missouri - Kansas City
- Special School District - St Louis
Maryland
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc. - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,143 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2024-03-29 |
| Phase | NA |
What the finished NCT04565509 record still lists
NCT04565509 is an interventional study that assigns participants to a tested intervention. Its 1,143 participants enrollment target places it among the larger protocols in the corpus, below the 38,461-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which COVID-19 Testing is the first listed.
NCT04565509 reports a single indexed study location in Missouri, Maryland.
Frequently Asked Questions
What is clinical trial NCT04565509 about?
NCT04565509 is a clinical study titled "Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic". 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...
What is the current status of trial NCT04565509?
This trial is currently completed. It is a NA study. The enrollment target is 1,143 participants. The study started on 2020-11-20. Estimated completion is 2024-03-29.
What conditions does trial NCT04565509 study?
This clinical trial studies the following conditions: COVID-19, Intellectual Disability, Developmental Disability, Child Development Disorder.
What interventions are being tested in trial NCT04565509?
The interventions under investigation include: COVID-19 Testing (DIAGNOSTIC_TEST), Focus Groups (BEHAVIORAL), Standard Messaging (BEHAVIORAL), Enhanced Messaging (BEHAVIORAL), Fuzzy Cognitive Mapping (BEHAVIORAL).
Who is sponsoring clinical trial NCT04565509?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04565509 being conducted?
This trial has 3 study locations across Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04565509's enrollment target sits among peer trials
1,143 66th of 298 higher than 233 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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