Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic

Covid19 Clinical Trial

Official title:

Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565509
• Other study ID #: 202009060
• Secondary ID: 3P50HD103525-01S
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: March 29, 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This research study will occur at six schools dedicated to children with IDD that are a part of the Special School Districts in St. Louis, MO. 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Child Development Disorder
• COVID-19
• Covid19
• Developmental Disabilities
• Developmental Disability
• Intellectual Disability

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

Outcome

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

External Links

•   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