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Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

NCT03845985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-12

Study results available
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Summary

The U.S. Deaf community - more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure as compared to the general population. Although there are validated treatments for alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments for any behavioral health condition that have been validated for use with Deaf clients. To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The study team's ongoing aims are to conduct a two-arm pilot RCT of "Signs of Safety" and to collect data on feasibility, preliminary clinical outcomes, and potential mediators and moderators of outcome.

Conditions

Interventions

BEHAVIORAL

Seeking Safety + Signs of Safety toolkit

Seeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., "Coping with Triggers," "Asking for Help"). "Signs of Safety" is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Melissa L Anderson, PhD · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2022-07-31
Completion
2022-07-31

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 NCT03845985 on ClinicalTrials.gov