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

NCT04565509 | Completed Results DMC

• 2 other identifiers: 2020090603P50HD103525-01S1
• Study Type: interventional
• Target: 1,143
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Covid19; Intellectual Disability; Developmental Disability; Child Development Disorder

Outcome Measures

Primary Outcomes (4)

• Enrollment Into Weekly Testing by Each Participant - Special School District

  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 interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The reported values reflect the percentage of participants enrolled per week.

  22 months

• Overall Testing Rate - Special School District

  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 interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants tested per week.

  22 months

• Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute

  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 interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants enrolled per week.

  22 months

• Overall Testing Rate - Kennedy Krieger Institute

  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 interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants tested per week.

  22 months

Secondary Outcomes (6)

• Key Themes and Subthemes: Perceptions of Returning to In-person Learning

  2 months

• Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing

  2 months

• Key Themes and Subthemes: Communication (Messages)

  2 months

• Key Themes and Subthemes: Communication (Messengers)

  2 month

• Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test

  up to 52 weeks

Study Arms (6)

SSD: Standard Messaging - Standard Messaging

ACTIVE COMPARATOR

In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.

Behavioral: Standard Messaging; Diagnostic Test: COVID-19 Testing

SSD: Standard Messaging - Enhanced Messaging

ACTIVE COMPARATOR

In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.

Behavioral: Standard Messaging; Behavioral: Enhanced Messaging; Diagnostic Test: COVID-19 Testing

KKI: Standard Messaging - Standard Messaging

ACTIVE COMPARATOR

In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.

Behavioral: Standard Messaging; Diagnostic Test: COVID-19 Testing

KKI: Standard Messaging - Enhanced Messaging

ACTIVE COMPARATOR

In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.

Behavioral: Standard Messaging; Behavioral: Enhanced Messaging; Diagnostic Test: COVID-19 Testing

Focus Groups

EXPERIMENTAL

Focus group were completed in Phase 1 to develop enhanced messaging. Focus group participants were not required to be enrolled in testing.

Behavioral: Focus Groups

Fuzzy Cognitive Mapping

EXPERIMENTAL

FCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing.

Behavioral: Fuzzy Cognitive Mapping

Interventions

Standard Messaging BEHAVIORAL

A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.

KKI: Standard Messaging - Enhanced Messaging; KKI: Standard Messaging - Standard Messaging; SSD: Standard Messaging - Enhanced Messaging; SSD: Standard Messaging - Standard Messaging

Enhanced Messaging BEHAVIORAL

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.

KKI: Standard Messaging - Enhanced Messaging; SSD: Standard Messaging - Enhanced Messaging

COVID-19 Testing DIAGNOSTIC_TEST

Weekly surveillance COVID-19 testing.

KKI: Standard Messaging - Enhanced Messaging; KKI: Standard Messaging - Standard Messaging; SSD: Standard Messaging - Enhanced Messaging; SSD: Standard Messaging - Standard Messaging

Focus Groups BEHAVIORAL

Focus groups to develop enhanced messaging.

Focus Groups

Fuzzy Cognitive Mapping BEHAVIORAL

FCMs to assess facilitators and barriers to COVID-19 testing.

Fuzzy Cognitive Mapping

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• Members of the research team will not be eligible to participate in the focus groups.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Washington University School of Medicine: lead

Study Sites (3)

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Baltimore, Maryland, 21205, United States

Location

University of Missouri

Kansas City, Missouri, 64110, United States

Location

Special School District

St Louis, Missouri, 63131, United States

Location

Related Publications (17)

• 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.

  PMID: 32600948 BACKGROUND

• 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.

  PMID: 19664226 BACKGROUND

• 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.

  PMID: 32690063 BACKGROUND

• 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.

  PMID: 20235862 BACKGROUND

• 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.

  PMID: 31036028 BACKGROUND

• 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.

  PMID: 32412064 BACKGROUND

• 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.

  PMID: 33098427 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32345686 BACKGROUND

• 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.

  PMID: 17763914 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• Jetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66.

  BACKGROUND

• 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.

  PMID: 37853427 DERIVED

• 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.

  PMID: 37704799 DERIVED

• 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.

  PMID: 36404403 DERIVED

• 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.

  PMID: 34465306 DERIVED

• 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.

  PMID: 34312616 DERIVED

Related 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

MeSH Terms

Conditions

COVID-19; Intellectual Disability; Developmental Disabilities

Interventions

COVID-19 Testing; Focus Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Jason Newland, MD
• Organization: Nationwide Children's Hospital

Jason.Newland@nationwidechildrens.org

614-722-3416

Study Officials

• Jason G. Newland, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster randomized adaptive trial will be conducted. The first phase will randomize the 6 Special School District schools to either a general message or focus/targeted message. Data analysis will occur and then the schools will be randomized to the best message strategy from phase 1 alone or best message plus and augmented message or implementation strategy. The same process will take place independently at the Kennedy Krieger Institutes/Sheppard Pratt Schools.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 25, 2020
• Study Start: November 20, 2020
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)