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Communicable DiseasesNCT06112249

SAFE Workplace Intervention for People With IDD

A study testing SAFE Employment Training in people with Communicable Diseases and Prevention, run by Temple University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAFE Employment Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
2 sitesUnited States
Study dates
24 Oct 2023to 1 Sep 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • JEVS

    Collingswood, New Jersey, 08108

  • Community Integrated Services

    Philadelphia, Pennsylvania, 19123

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
SAFE Employment Training
Medical subject headings
Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAFE Employment TrainingBehavioural

    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).

Study groups in NCT06112249
Study groupRoleWhat they receive
Control GroupNo interventionDoes not receive curriculum.
Peer InterventionExperimentalReceives curriculum taught by Peer Interventionist
Receives: Behavioral: SAFE Employment Training
Staff DeliveredExperimentalReceives curriculum taught by staff
Receives: Behavioral: SAFE Employment Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)

Secondary outcomes (5)
  1. 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.

    Measured: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)

  2. 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 "never" (1) to "very often" (5) with higher scores reflecting greater general self-efficacy. The scale (average across 10 questions) ranges from 1 to 5.

    Measured: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)

  3. Vocational Fit Assessment Safety Subscale

    The Vocfit is an assessment tool used to measure the best fit for a worker with a job. The tool was specifically developed for individuals with developmental disabilities and has strong psychometric properties for this population. Participants will complete the 10-question tool which is designed for people 18 years and older. The responses are on a 3 point scale from "Low = you can do it but you need someone else to help you the whole time" (0) to "High = you can do it by yourself" (2) with higher scores reflecting better fit for a worker with a job. The scale (average across 10 questions) ranges from 0 to 2.

    Measured: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)

  4. 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 10 items with a response range from "Never" (1) to "Very Often" (5). Higher scores reflect greater levels of perceived stress. The scale (average across 10 questions) ranges from 1 to 5.

    Measured: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)

  5. 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 "Always" (5). Higher scores reflect greater levels of anxiety. It has established acceptable psychometrics and is sensitive to change. The scale (average across 8 questions) ranges from 1 to 5.

    Measured: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start24 Oct 2023
  3. Primary completion26 Apr 2024
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three arm study with a control group, a peer interventionist group and staff delivered group.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112249
Sponsor's protocol ID
27789
Status last verified
Jan 2026
First submitted
26 Oct 2023
Last updated
28 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pfeiffer, B., Davidson, A., Kelly, P. J., Luck, C., Singley, K., & Bass, S. (2024). Infectious Airborne Disease Knowledge, Training Preferences, and Peer Support Acceptance among Young Working Autistic Adults: A Qualitative Inquiry. Journal of Vocational Rehabilitation, 10522263251337562.

Questions about this trial

What is this clinical trial studying?

A study testing SAFE Employment Training in people with Communicable Diseases and Prevention, run by Temple University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infectious Airborne Disease Knowledge and Preventative Behaviors Outcomes (time frame: Pre Data (before intervention), Post1 (immediately following), Post2 (1 month after)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06112249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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