Clinical trial NCT04565509: Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Official title: Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Intellectual Disability
Developmental Disability
Child Development Disorder
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-09-25
Enrollment: 3000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adoption of weekly testing by each participant
timeFrame: 52 weeks
Secondary outcomes:
measure: Acceptability of Messaging/Implementation Strategy
timeFrame: 1 year
measure: Feasibility of Messaging/Implementation Strategy
timeFrame: 1 year
measure: Appropriateness of Messaging/Implementation Strategy
timeFrame: 1 year
measure: Number of missed school days by students or work days by staff
timeFrame: 52 weeks
measure: Students and staff positive SARS-CoV-2 virus
timeFrame: 52 weeks
measure: School-based SARS-CoV-2 transmission events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
state: Maryland
city: Kansas City
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Special School District
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jason G. Newland, MD
role: PRINCIPAL_INVESTIGATOR
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