SAFE Workplace Intervention for People With IDD

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112249
• Other study ID #: 27789
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Temple University
• Contact: Beth Pfeiffer, PHD
• Phone: 2152040828
• Email: elizabeth.pfeiffer[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

It is hypothesized that the SAFE program will have a positive effect on perceived well-being and knowledge of the actionable behaviors for the prevention of COVID-19 and other airborne diseases. The program will have a larger effect on outcomes when provided using peer support compared to staff training. Individuals with IDD will demonstrate increased knowledge and safe behaviors after completing the SAFE program. Peer-interventionists will report perceived benefits and limitations of participating in training and providing peer-mediated travel training interventions to identify potential outcomes for future research.

The research intends to answer these questions:

Does participation in the SAFE program increase perceived safety and well-being in the workplace for people with Autism Spectrum Disorder (ASD) and/or Intellectual or Developmental Disabilities (IDD)? Does participation in the SAFE program increase knowledge of actionable behaviors to prevent transmission of airborne diseases (i.e. COVID-19) in the workplace for people with IDD? When implemented through peer support, does the SAFE program have a larger increase in perceived well-being and knowledge of actionable behaviors to prevent transmission of airborne diseases (i.e. COVID-19) than when implemented through staff training and supports?

The research further intends to:

Develop health communication messages related to safe interactions and the prevention of COVID-19 and other infectious airborne diseases for autistic adults

Refine and expand the SAFE program based on stakeholder priorities and input

Evaluate the SAFE program training with Autistic adults Procedures.

The researchers will leverage current relationships with community organizations to recruit 100 participants with ASD and or IDD who are employed 10 hours or more a week and receiving employment services or supports. Organizational administrators will provide information on the study to individuals that meet the inclusion criteria. Interested individuals will contact the project research coordinator to determine inclusion. Eligible participants will be randomized into one of the 3 arms of the study, Control, Peer Interventionist Led, Staff Led.

If the participant is assigned to the staff intervention support staff will be contacted with an email or phone call. Staff members will be required to complete human subjects training. Researchers will obtain informed consent for all participants. During the first contact made with participants, written information will be provided remotely using Zoom/FaceTime or in person to all participants explaining the following in simple terms: 1) the criteria for participation, 2) the purpose of the research and the procedures involved, 3) the subject's right to withdraw at any time without penalty of any sort, 4) potential benefits to the subject, 5) potential risks, 6) assurance of anonymity, and 7) terms of remuneration. All research staff will complete training about the informed consent process prior to consenting subjects. The information described above will be reviewed and any questions answered. Participants will be obtained signed or a printed signature box used for signature when electronic signatures are unable to be obtained for consent either in person or virtually.

The researchers will collect data from young adults or transitional aged-youth with ASD or IDD to determine the efficacy and feasibility of the intervention. Recruitment occurs through the sites identified in the participant recruitment section of this proposal. Participants interested in the study will contact the primary investigator or research staff who will schedule an initial physical or virtual meeting at a place and time convenient for the participant to determine inclusion and obtain consent/assent. Participants are randomly assigned to either peer-support intervention, staff intervention or a control group. The researchers will randomize in blocks of 12 (4 to each group) until the investigators reach the targeted number of 120 or 40 participants in each group. Pre-test and post-test measures will be administered by researcher staff prior to the start of the intervention (Pre-test) and at the end of the intervention 4 weeks (Post-test ). Key stakeholders, including the participants and interventionists (occupational therapists and peer mediators), will complete qualitative interviews at the end of the intervention period for each participant. The information gathered will determine acceptability and feasibility of intervention. Participants will be asked to discuss their experiences during the intervention specific to their assigned intervention group.

A member from the research team will then contact interested individuals to set up a convenient meeting time and place for the SAFE program training. These meetings will occur remotely or in a private location convenient to the participant. The SAFE program course training will occur in small group settings or individually. The course trainings will occur 2-3 times per week for between 45-60 minutes. An appropriate curriculum has been developed by Temple University Researchers and Occupational therapy students based on many qualitative interviews, research of proper education methods, and COVID-19 practices. The curriculum is based on a series of classes designed to create an understanding of best practices and behaviors to prevent the spread of COVID-19 in the workplace. The curriculum will be adapted to meet the needs of this project and study population. The course will provides instruction in the following areas: 1) COVID-19 and how it spreads 2) Personal Protective Equipment (PPE) and How to use it properly 3) Social Distancing 4) Community Participation 5) Employment 6) Self Efficacy.

Participants will complete the SAFE program sessions remotely or in person in a private, quiet and convenient setting.. Participants will be randomized into two treatment arms and a control group. The first treatment arm will receive the SAFE program implemented through a staff training model. The second group will receive the program using a peer support model. The control group will continue to receive their standard vocational rehabilitation supports.

Training of the SAFE program will occur remotely or in person by staff who are trained within our research team or will be implement it in collaboration with staff or a peer specialist remotely as part of their current services. If it is in person it will be implemented at their vocational rehabilitation centers or places of employment. Research staff will be available to support the process after the training is complete.

The researchers will use a questionnaire to assess knowledge of actionable behaviors to prevent COVID-19, which reflect the core components of the SAFE program (social distancing, proper use of PPE, personal hygiene practices, and self-advocacy in the workplace). The researchers will also administer measures to determine the degree of self-advocacy and self-efficacy in the work place reported by staff and self-reported by participants. The researchers will determine how well a participant follows workplace procedures. Data will be collected either in person or virtually both at pre-test and post-test for all outcome measures. Finally, the investigators will assess perceived anxiety.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Prevention

Intervention

Behavioral:
• SAFE Employment Training
The SAFE program includes lessons in the following areas: 1) Overview of What COVID-19 is and how it spreads 2) What is PPE and How to properly use 3) Social Distancing 4) Community Participation 5) Employment 6) Self Efficacy. We would also like to know if you learn more when the SAFE program is taught by a peer (person who also has an intellectual developmental disability).

Locations

Country	Name	City	State
United States	JEVS	Collingswood	New Jersey
United States	Community Integrated Services	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

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)