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,
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. — View Citation
Jetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66.
Lalli MA, Langmade JS, Chen X, Fronick CC, Sawyer CS, Burcea LC, Wilkinson MN, Fulton RS, Heinz M, Buchser WJ, Head RD, Mitra RD, Milbrandt J. Rapid and Extraction-Free Detection of SARS-CoV-2 from Saliva by Colorimetric Reverse-Transcription Loop-Mediated Isothermal Amplification. Clin Chem. 2021 Jan 30;67(2):415-424. doi: 10.1093/clinchem/hvaa267. — View Citation
Landes SD, Turk MA, Formica MK, McDonald KE, Stevens JD. COVID-19 outcomes among people with intellectual and developmental disability living in residential group homes in New York State. Disabil Health J. 2020 Oct;13(4):100969. doi: 10.1016/j.dhjo.2020.100969. Epub 2020 Jun 24. — View Citation
Rader B, Astley CM, Sy KTL, Sewalk K, Hswen Y, Brownstein JS, Kraemer MUG. Geographic access to United States SARS-CoV-2 testing sites highlights healthcare disparities and may bias transmission estimates. J Travel Med. 2020 Nov 9;27(7):taaa076. doi: 10.1093/jtm/taaa076. No abstract available. — View Citation
Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S. Nine key functions for a human subjects protection program for community-engaged research: points to consider. J Empir Res Hum Res Ethics. 2010 Mar;5(1):33-47. doi: 10.1525/jer.2010.5.1.33. — View Citation
Silliman Cohen RI, Bosk EA. Vulnerable Youth and the COVID-19 Pandemic. Pediatrics. 2020 Jul;146(1):e20201306. doi: 10.1542/peds.2020-1306. Epub 2020 Apr 28. No abstract available. — View Citation
Steiner JF. Using stories to disseminate research: the attributes of representative stories. J Gen Intern Med. 2007 Nov;22(11):1603-7. doi: 10.1007/s11606-007-0335-9. Epub 2007 Sep 1. — View Citation
Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4. — View Citation
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. — View Citation
Wylie AL, Fourneir J, Casanovas-Massana A, et al. Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. medRxiv. 2020.
Zhou G, Lee MC, Atieli HE, Githure JI, Githeko AK, Kazura JW, Yan G. Adaptive interventions for optimizing malaria control: an implementation study protocol for a block-cluster randomized, sequential multiple assignment trial. Trials. 2020 Jul 20;21(1):665. doi: 10.1186/s13063-020-04573-y. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |