Covid19 Clinical Trial
Official title:
Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Verified date | May 2024 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3000 |
Est. completion date | March 29, 2024 |
Est. primary completion date | March 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland |
United States | University of Missouri | Kansas City | Missouri |
United States | Special School District | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Hugo W. Moser Research Institute at Kennedy Krieger, Inc., National Institutes of Health (NIH), University of Missouri, Kansas City |
United States,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adoption of weekly testing by each participant | Ratio of the total number test per the number of weeks of analysis (eg. Phase 1 - 20 weeks) | 52 weeks | |
Secondary | Acceptability of Messaging/Implementation Strategy | The acceptability of each strategy will be assessed with a validated survey of the families and staff prior to the intervention and at the conclusion of the intervention being utilized. | 1 year | |
Secondary | Feasibility of Messaging/Implementation Strategy | The feasibility of each strategy will be assessed with a validated survey of the families and staff prior to the intervention and at the conclusion of the intervention being utilized. | 1 year | |
Secondary | Appropriateness of Messaging/Implementation Strategy | The appropriate of each strategy will be assessed with a validated survey of the families and staff prior to the intervention and at the conclusion of the intervention being utilized. | 1 year | |
Secondary | Number of missed school days by students or work days by staff | The total number of days missed by students and staff at the special schools during the 52 weeks of the study will be obtained. | 52 weeks | |
Secondary | Students and staff positive SARS-CoV-2 virus | The percentage of students and staff positive for SARS-CoV-2 virus will be determined | 52 weeks | |
Secondary | School-based SARS-CoV-2 transmission events | Number of possible SARS-CoV-2 transmission events occurring between students and staff within the school setting. | 52 weeks |
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