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

The Washington University

Status: Completed

Conditions: Covid19; Developmental Disability; Child Development Disorder; Intellectual Disability

Treatments: Behavioral: Best Message + Augmented Message or Implementation Strategy; Behavioral: General Communication Message; Behavioral: Focused/Targeted Message; Behavioral: Best Message Alone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04565509

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

202009060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 patients

Sex: All

Ages: 5 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 4 patient groups

General Message

Active Comparator group

Description:

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.

Treatment:

Behavioral: General Communication Message

Focus/Targeted Message

Active Comparator group

Description:

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.

Treatment:

Behavioral: Focused/Targeted Message

Best Message Alone

Active Comparator group

Description:

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.

Treatment:

Behavioral: Best Message Alone

Best Message + Augmented Message or Implementation Strategy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Best Message + Augmented Message or Implementation Strategy