Prevention Clinical Trial
Official title:
Efficacy of the SAFE Program to Promote Preventative Behaviors of Airborne Diseases (COVID-19) and Improve Well-Being for People With Intellectual and Developmental Disabilities in the Workplace
NCT number | NCT06112249 |
Other study ID # | 27789 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2021 |
Est. completion date | September 2024 |
The purpose of this study is to examine the feasibility and efficacy of a systematic training approach targeting behaviors to increase safety and prevention of airborne diseases such as COVID-19 in the workplace for individuals with Intellectual and Developmental Disabilities (IDD). This project is designed to determine proof of concept and proof of product for a peer support intervention, the SAFE program, to increase knowledge and safe workplace practices. There is an identified immediate need for individuals with IDD to receive training in an accessible format. The SAFE program has been developed in an accessible format for those with IDD. It focuses on education regarding actionable behaviors that reduce the risk of acquiring and transmitting COVID-19 and other airborne diseases. The study will implement a peer-mediated and occupational therapy lead program, SAFE, to identify and address potential implementation issues and further refine the program curriculum. Additionally, the efficacy of the program on perceived safety and well-being, observable preventative behaviors and self-advocacy will be examined.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | September 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The researchers anticipate recruiting young adults 18years old and over with ASD or IDD who are currently employed or actively looking for employment to participate in the study. Participants will have a diagnosis of ASD or IDD. Participants will self-report their ASD or IDD diagnosis. Additionally, the community agencies have access to documentation that identifies their consumer's diagnoses. Based on this, the researchers will ask them to only provide information to those individuals who have a diagnosis of IDD. Potentially eligible participants with documented intellectual and developmental disabilities will be recruited through large vocational rehabilitation organizations (Community Integrated Services [CIS] and Project Search) that together serve over 1200 adults with IDD. Participants must be working a minimum of 10 hours a week outside the home and/or receive vocational rehabilitation services. Exclusion Criteria: - under 18 years, do not have a minimum of 10 hours/week of work experience, do not have Autism Spectrum Disorder and/or Intellectual Disability |
Country | Name | City | State |
---|---|---|---|
United States | JEVS | Collingswood | New Jersey |
United States | Community Integrated Services | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | National Institute on Disability, Independent Living, and Rehabilitation Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes | The Infectious Airborne Disease Knowledge and Prevention of Behavior Outcomes is an assessment to see the knowledge of infectious airborne disease preventative behaviors gained through the SAFE curriculum. The assessment is completed through true and false questions, multiple choice questions, open ended questions, and behavior observations. Score: 1 - 67. Higher scores mean better outcomes. | PRE Data (before intervention), POST1 (immediately following), POST2 (1 month after) | |
Secondary | Workplace Health and Safety Assessment | This measure was adapted from employment-centered items on the Self-Determination and Self-Advocacy Questionnaire, which assess the degree of self-advocacy in the workplace as reported by staff and self-reported by participants. Score: 1 - 25. Higher scores mean better outcomes. | PRE Data (before intervention), POST1 (immediately following), POST2 (1 month after) | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank | This measure assesses a person's belief in their capacity to manage daily stressors and have control over meaningful events. Participants will complete the 10-question tool which is designed for people 18 years and older. It has established acceptable reliability and validity.81 The responses are on a 5 point scale from "I am a little confident" (1) to "I am very confident" (5) with higher scores reflecting greater general self-efficacy. | PRE Data (before intervention), POST1 (immediately following), POST2 (1 month after) | |
Secondary | Vocational Fit Assessment Safety Subscale | The VocFit is an assessment tool used to measure the best fit for a worker with a job.8 The tool was specifically developed for individuals with developmental disabilities and has strong psychometric properties for this population. | PRE Data (before intervention), POST1 (immediately following), POST2 (1 month after) | |
Secondary | National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+). | This measure assesses "perceptions about the nature of events and their relationship to the values and perceived coping resources of an individual" for adults 18 years and older. This self-report measure has 14 items with a response range from "Never" (1) to "Very Often" (5). Higher scores reflect greater levels of perceived stress. | PRE Data (before intervention), POST1 (immediately following), POST2 (1 month after) | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8. | This measure assesses anxiety for adults 18 years and older. This self-report measure has 8 items with a response range from "Never" (1) to "Very Often" (5). Higher scores reflect greater levels of anxiety. It has established acceptable psychometrics and is sensitive to change. | PRE Data (before intervention), POST1 (immediately following), POST2 (1 month after) |
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