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Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma

NCT06278922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-06-15

No results posted yet for this study

Summary

The U.S. Deaf community - a group of more than one million Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome.

Conditions

  • PTSD
  • Alcohol; Use, Problem

Interventions

BEHAVIORAL

Seeking Safety + Signs of Safety toolkit

Signs of Safety is a Deaf-accessible toolkit to be used with the Seeking Safety treatment protocol. Seeking Safety is a manualized, non-exposure-based, cognitive behavioral therapy for trauma and addiction.

BEHAVIORAL

Treatment as usual

NDT therapists come from a wide variety of training backgrounds, but each works with their clients to build on their existing strengths and provide support as clients develop new strategies and behaviors for overcoming adversity.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06278922 on ClinicalTrials.gov