Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
NCT ID: NCT04565509
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3000 participants
INTERVENTIONAL
2020-11-20
2024-03-29
Brief Summary
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Detailed Description
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Additionally, surveys, focus groups, and fuzzy cognitive mapping sessions will be conducted at these six schools and at schools within the Kennedy Krieger School Programs in Baltimore, MD. Finally, a national survey will be administered to 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).
The first aim will involve focus groups of parents/guardians, teachers, and school staff to identify the barriers and facilitators to frequent SARS-CoV-2 testing, impressions of COVID-19, and best messages and implementation strategies to promote increase testing and vaccination. A formal process for developing two types of messages (general versus focused) will be performed using focus group data and involving key stakeholders to test the messages. A cluster randomized adaptive clinical trial will then occur at the six special school district schools. In phase 1, the schools will be randomized initially to either the general or focused message to promote the adoption of weekly SARS-CoV-2 testing by the students and teachers. After 5 months, data analysis will be conducted to determine which strategy led to the highest percentage of testing. Phase 2 will begin at 7 months after the schools are randomized to either the best message determined from phase 1 or best message plus an augmented implementation strategy.
Beginning in April 2021 the first aim was expanded to include weekly testing and message development at the Kennedy Krieger Institutes and Sheppard Pratt Schools in Baltimore, MD. In phase 1, these schools will be randomized initially to either the general or focused message to promote the adoption of weekly SARS-CoV-2 testing by the students and teachers. After 5 months, data analysis will be conducted to determine which strategy led to the highest percentage of testing. Phase 2 will begin at 7 months after these schools are randomized to either the best message determined from phase 1 or best message plus an augmented implementation strategy.
The second aim will assess the national perspectives among parents of children with IDD and school staff regarding the impact of COVID-19 and importance of SARS-CoV-2 testing. Fuzzy cognitive mapping (FCM) and the administration of local and national surveys will be used to accomplish this aim. FCM will involve in-person sessions with parents from the schools in aim 1 and Kennedy Krieger Institute/Sheppard Pratt schools in Baltimore, MD for children with IDD. These sessions will help identify the facilitators and barriers SARS-CoV-2 testing and other mitigation strategies including COVID-19 vaccine. Since no accepted measures have been developed for understanding parent and school staff concerns for children with IDD around COVID-19, local (St. Louis and Baltimore) and national surveys will be conducted. Custom surveys will be deployed across two stakeholder groups: parent/guardians and school staff. We will administer the survey at baseline and during the trial across school settings (St. Louis and Baltimore).
A national survey will also be administered across the UCEDDs. Psychometric analysis will be performed to help identify the questions for a national survey at the end of the study period. In addition to the custom surveys, NIH recommended parent-report surveys from the PhenX Toolkit will be used. The surveys to be used include the Psychological Stress Associated with the COVID-19 Crisis Scale and COVID-19 impact questionnaires.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
The same process will take place independently at the Kennedy Krieger Institutes/Sheppard Pratt Schools.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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General Message
In phase 1, three schools will be randomized to a messaging strategy that is developed from focus groups that generally describes COVID-19 and the importance of testing.
General Communication Message
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Focus/Targeted Message
In phase 1, three schools will be randomized to 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 FG input.
Focused/Targeted Message
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.
Best Message Alone
In phase 2, the schools will be randomized a second time after data analysis at 5 months to determine which communication strategy is determined to provide the best uptake of testing by students and staff. Three schools will be randomized to receive the best messaging strategy alone to begin at 7 months after testing starts.
Best Message Alone
The best message will be either the general or focused/targeted message described above.
Best Message + Augmented Message or Implementation Strategy
In phase 2, the schools will be randomized a second time after data analysis at 5 months to determine which communication strategy is determined to provide the best uptake of testing by students and staff. Three schools will be randomized to receive the best messaging strategy plus an augmented messaging or implementation strategy. The augmented messaging and implementation strategies will be informed by the barriers and facilitators identified based on the CFIR domains and results of focus groups and surveys in Aim 2.
Best Message + Augmented Message or Implementation Strategy
The augmented messaging and implementation strategies will be informed by the barriers and facilitators identified based on the CFIR domains and results of focus groups and surveys in Aim 2.
Interventions
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General Communication Message
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Focused/Targeted Message
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.
Best Message Alone
The best message will be either the general or focused/targeted message described above.
Best Message + Augmented Message or Implementation Strategy
The augmented messaging and implementation strategies will be informed by the barriers and facilitators identified based on the CFIR domains and results of focus groups and surveys in Aim 2.
Eligibility Criteria
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Inclusion Criteria
* 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
5 Years
90 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jason G. Newland, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, United States
University of Missouri
Kansas City, Missouri, United States
Special School District
St Louis, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Jetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66.
Vestal LE, Schmidt AM, Dougherty NL, Rolf L, Newland JG, Mueller NB; COMPASS-T Study Group. COVID-19 Related Facilitators and Barriers to In-Person Learning for Children With Intellectual and Development Disabilities: A Follow-Up. J Sch Health. 2024 Feb;94(2):105-116. doi: 10.1111/josh.13404. Epub 2023 Oct 18.
Gemmell M, Walsh T, Sherby M, Imbeah A, Bono K, Baldenweck M, Gurnett C, Newland JG. Clusters of SARS-CoV-2 Infection Across Six Schools for Students with Intellectual and Developmental Disabilities. Infect Dis Ther. 2023 Sep;12(9):2289-2294. doi: 10.1007/s40121-023-00855-5. Epub 2023 Sep 13.
Vestal LE, Schmidt AM, Dougherty NL, Sherby MR, Newland JG, Mueller NB; COMPASS-T Study Group. COVID-19-Related Facilitators and Barriers to In-Person Learning for Children With Intellectual and Development Disabilities. J Sch Health. 2023 Mar;93(3):176-185. doi: 10.1111/josh.13262. Epub 2022 Nov 20.
Sherby MR, Walsh TJ, Lai AM, Neidich JA, Balls-Berry JE, Morris SM, Head R, Prener CG, Newland JG, Gurnett CA; COMPASS-T Study Group. SARS-CoV-2 screening testing in schools for children with intellectual and developmental disabilities. J Neurodev Disord. 2021 Sep 1;13(1):31. doi: 10.1186/s11689-021-09376-z.
Sherby MR, Walsh T, Lai AM, Neidich JA, Balls-Berry JE, Morris SM, Head R, Prener C, Newland JG, Gurnett CA; COMPASS-T Study Group. SARS-CoV-2 Screening Testing in Schools for Children with Intellectual and Developmental Disabilities. Res Sq [Preprint]. 2021 Jul 20:rs.3.rs-700296. doi: 10.21203/rs.3.rs-700296/v1.
Related Links
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Brown School Evaluation Center at Washington University in St. Louis
Health Communication Research Laboratory at Washington University in St. Louis
Intellectual and Developmental Disabilities Research Center at Washington University in St. Louis
Kennedy Krieger Institute Intellectual and Developmental Disabilities Research Center
Other Identifiers
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202009060
Identifier Type: -
Identifier Source: org_study_id