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Messaging Strategies for COVID-19 Safety in Children with Developmental Disorders

N/A

Waitlist Available

Led By Jason G. Newland, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will help identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with IDD and their teachers to ensure a safe school environment. Additionally, the trial 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.

Who is the study for?

This trial is for teachers, staff, and parents associated with special schools in St. Louis and Maryland that serve children with intellectual and developmental disabilities (IDD), as well as families connected to University Centers for Excellence in Developmental Disabilities. Research team members are excluded.Check my eligibility

What is being tested?

The study aims to find the most effective messages and strategies to encourage COVID-19 testing among children with IDD and their educators. It will compare different types of communication approaches to see which one leads to higher testing rates.See study design

What are the potential side effects?

Since this trial focuses on messaging strategies rather than medical interventions, there are no direct side effects related to drugs or treatments. The impact studied is on behavior regarding COVID-19 testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adoption of weekly testing by each participant

Secondary outcome measures

Acceptability of Messaging/Implementation Strategy

Appropriateness of Messaging/Implementation Strategy

Feasibility of Messaging/Implementation Strategy

+3 more

Trial Design

4Treatment groups

Active Control

Group I: General MessageActive Control1 Intervention

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.

Group II: Best Message AloneActive Control1 Intervention

Group III: Best Message + Augmented Message or Implementation StrategyActive Control1 Intervention

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.

Group IV: Focus/Targeted MessageActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.OTHER

88 Previous Clinical Trials

21,938 Total Patients Enrolled

1 Trials studying Intellectual Disability

3,000 Patients Enrolled for Intellectual Disability

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,296,709 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,949,588 Total Patients Enrolled

5 Trials studying Intellectual Disability

12,785 Patients Enrolled for Intellectual Disability

Media Library

General Message Clinical Trial Eligibility Overview. Trial Name: NCT04565509 — N/A

Intellectual Disability Research Study Groups: General Message, Best Message Alone, Best Message + Augmented Message or Implementation Strategy, Focus/Targeted Message

Intellectual Disability Clinical Trial 2023: General Message Highlights & Side Effects. Trial Name: NCT04565509 — N/A

General Message 2023 Treatment Timeline for Medical Study. Trial Name: NCT04565509 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for participation in this research program?

"This clinical trial needs 3000 participants, aged between 5 and 90 years old, diagnosed with intellectual disability. Moreover, the enrollees must either be teachers/staff from St Louis Special Schools or Kennedy Krieger Institute/Sheppard Pratt School in Maryland; students enrolled at these educational facilities; parents of such pupils; staff members employed by 67 University Centers for Excellence in Developmental Disabilities (UCEDD) connected to Association of University Centers for Disability (AUCD)."

Answered by AI

Is enrollment still available for this experimental research?

"The details available on clinicaltrials.gov show that this particular medical trial is not open for new participants at the moment, having been initially posted in November 2020 and last updated in August of 2022. Nevertheless, there are 1101 other trials currently recruiting candidates from across the world."

Answered by AI

Does this study accept participants aged seventy and older?

"Patients applying for this trial must fall between 5 and 90 years of age. There are 180 clinical trials specifically designed to accommodate those under 18, while 928 such studies exist for individuals aged 65 or above."

Answered by AI

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