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

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ClinicalTrials.gov Identifier: NCT04565509
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
University of Missouri, Kansas City
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jason Newland, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Covid19 Intellectual Disability Developmental Disability Child Development Disorder Behavioral: General Communication Message Behavioral: Focused/Targeted Message Behavioral: Best Message Alone Behavioral: Best Message + Augmented Message or Implementation Strategy Not Applicable

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.

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 6 schools in aim 1 and 4 Kennedy Krieger Institute 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A cluster randomized adaptive trial will be conducted. The first phase will randomize 6 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 21, 2022


Arm Intervention/treatment
Active Comparator: General Message
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
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.

Active Comparator: Focus/Targeted Message
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
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: Best Message Alone
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
The best message will be either the general or focused/targeted message described above.

Active Comparator: Best Message + Augmented Message or Implementation Strategy
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
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.




Primary Outcome Measures :
  1. Adoption of weekly testing by each participant [ Time Frame: 52 weeks ]
    Ratio of the total number test per the number of weeks of analysis (eg. Phase 1 20 weeks)


Secondary Outcome Measures :
  1. Acceptability of Messaging/Implementation Strategy [ Time Frame: 1 year ]
    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.

  2. Feasibility of Messaging/Implementation Strategy [ Time Frame: 1 year ]
    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.

  3. Appropriateness of Messaging/Implementation Strategy [ Time Frame: 1 year ]
    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.

  4. Number of missed school days by students or work days by staff [ Time Frame: 52 weeks ]
    The total number of days missed by students and staff at the special schools during the 52 weeks of the study will be obtained.

  5. Students and staff positive SARS-CoV-2 virus [ Time Frame: 52 weeks ]
    The percentage of students and staff positive for SARS-CoV-2 virus will be determined

  6. School-based SARS-CoV-2 transmission events [ Time Frame: 52 weeks ]
    Number of possible SARS-CoV-2 transmission events occurring between students and staff within the school setting.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Students enrolled in the St. Louis Special School District.
  • Teachers/Staff working at the 6 St. Louis Special Schools 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565509


Contacts
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Contact: Jason G. Newland, MD 314 747-5128 jgnewland@wustl.edu

Locations
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United States, Maryland
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, United States, 21205
Contact: Bradley Schlaggar, MD, PhD         
United States, Missouri
University of Missouri
Kansas City, Missouri, United States, 64110
Contact: George S Grotto, PhD         
Sponsors and Collaborators
Washington University School of Medicine
University of Missouri, Kansas City
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Jason G. Newland, MD Washington University School of Medicine
Additional Information:
Publications:
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.
Jetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66.

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Responsible Party: Jason Newland, Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04565509    
Other Study ID Numbers: 202009060
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intellectual Disability
Developmental Disabilities
Neurologic Manifestations
Nervous System Diseases
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Mental Disorders