NCT06112249

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

October 26, 2023

Results QC Date

July 1, 2025

Last Update Submit

January 9, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Workplace Health and Safety Assessment

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

  • Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Item Bank

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

  • Vocational Fit Assessment Safety Subscale

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

  • National Institutes of Health (NIH) Toolbox Item Bank/Fixed Form v2.0 - Perceived Stress (Ages 18+).

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

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Anxiety Short Form 8.

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

Study Arms (3)

Control Group

NO INTERVENTION

Does not receive curriculum.

Peer Intervention

EXPERIMENTAL

Receives curriculum taught by Peer Interventionist

Behavioral: SAFE Employment Training

Staff Delivered

EXPERIMENTAL

Receives curriculum taught by staff

Behavioral: SAFE Employment Training

Interventions

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).

Peer InterventionStaff Delivered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

JEVS

Collingswood, New Jersey, 08108, United States

Location

Community Integrated Services

Philadelphia, Pennsylvania, 19123, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample is limited to the Philadelphia area, reducing generalizability. Randomization occurred by classroom, not individual, which may have influenced responses due to differences in support needs. One classroom had higher overall support, possibly affecting how lessons were accessed and surveys completed.

Results Point of Contact

Title
Beth Pfeiffer
Organization
Temple University

Study Officials

  • Beth Pfeiffer, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The statistician will blindly randomize the three arm groups. The only staff with access to the groups will be the research coordinator. The primary investigators are blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Three arm study with a control group, a peer interventionist group and staff delivered group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

October 24, 2023

Primary Completion

April 26, 2024

Study Completion

September 1, 2025

Last Updated

January 28, 2026

Results First Posted

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations