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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Intellectual Disability, Developmental Disability, Child Development Disorder

Intervention / Treatment
-----------------
* Behavioral: General Communication Message
* Behavioral: Focused/Targeted Message
* Behavioral: Best Message Alone
* Behavioral: Best Message + Augmented Message or Implementation Strategy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Message<br>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. | Behavioral: General Communication Message<br>* A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.<br>|
| Active Comparator: Focus/Targeted Message<br>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. | Behavioral: Focused/Targeted Message<br>* 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.<br>|
| Active Comparator: Best Message Alone<br>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. | Behavioral: Best Message Alone<br>* The best message will be either the general or focused/targeted message described above.<br>|
| Active Comparator: Best Message + Augmented Message or Implementation Strategy<br>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. | Behavioral: Best Message + Augmented Message or Implementation Strategy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |