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

January 30, 2026 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    • Missouri
      • Kansas City, Missouri, United States, 64110
        • University of Missouri
      • St Louis, Missouri, United States, 63131
        • Special School District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SSD: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
Behavioral: Standard Messaging
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Diagnostic test: COVID-19 Testing
Weekly surveillance COVID-19 testing.
Active Comparator: SSD: Standard Messaging - Enhanced Messaging
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
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Diagnostic test: COVID-19 Testing
Weekly surveillance COVID-19 testing.
Behavioral: Enhanced Messaging
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.
Active Comparator: KKI: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.
Behavioral: Standard Messaging
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Diagnostic test: COVID-19 Testing
Weekly surveillance COVID-19 testing.
Active Comparator: KKI: Standard Messaging - Enhanced Messaging
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
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Diagnostic test: COVID-19 Testing
Weekly surveillance COVID-19 testing.
Behavioral: Enhanced Messaging
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.
Experimental: Focus Groups
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
Focus groups to develop enhanced messaging.
Experimental: Fuzzy Cognitive Mapping
FCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing.
Behavioral: Fuzzy Cognitive Mapping
FCMs to assess facilitators and barriers to COVID-19 testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Into Weekly Testing by Each Participant - Special School District
Time Frame: 22 months
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
Time Frame: 22 months
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
Time Frame: 22 months
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
Time Frame: 22 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Time Frame: 2 months
Key themes and subthemes of participants' perceptions of returning to in-person learning
2 months
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Time Frame: 2 months
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
2 months
Key Themes and Subthemes: Communication (Messages)
Time Frame: 2 months
Key Themes and Subthemes: Communication (messages)
2 months
Key Themes and Subthemes: Communication (Messengers)
Time Frame: 2 month
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
Time Frame: up to 52 weeks

Structural equation modeling (SEM) was used to confirm the results of the FCM analyses. SEM is a combination of confirmatory factor analysis (CFA) and multiple regression that identifies the relationships among latent constructs. For the purpose of the current study, SEM analyses examined the effects of facilitators and barriers related to a Successful SARS-COV-2 Test.

The factor loadings in the tables can be interpreted on the following scale:

0.70+ -> Strong 0.50 -> Moderate 0.30 -> Weak but acceptable
up to 52 weeks
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Time Frame: up to 52 weeks

In the one-factor model, Structural equation modeling (SEM) was used for pinpointing key items that loaded onto Successful SARS-COV-2 Test

The factor loadings in the tables can be interpreted on the following scale:

0.70+ -> Strong 0.50 -> Moderate 0.30 -> Weak but acceptable
up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Jason G. Newland, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

March 29, 2024

Study Completion (Actual)

March 29, 2024

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202009060
  • 3P50HD103525-01S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Standard Messaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe