A Deaf-accessible therapy toolkit for treating alcohol use disorder and trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Signs of Safety therapy toolkit, specifically designed for the Deaf community, in treating alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The study will compare the Signs of Safety intervention with standard treatment and a no-treatment control group, utilizing a nationwide virtual format. Participants will include Deaf individuals who are proficient in American Sign Language and meet specific criteria for problematic alcohol consumption and PTSD symptoms. The trial seeks to gather data on clinical outcomes and understand factors that may influence treatment effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Self-identification as Deaf or hard-of-hearing
* Proficiency in American Sign Language (ASL)
* Age 18 years or older
* Access to videoconferencing technology for informed consent and, if applicable, study therapy sessions
* Access to online survey technology for study assessments
* "Problematic alcohol consumption, drinking behaviors, and alcohol-related problems" on the AUD Identification Test (AUDIT), a 10-item screening measure developed by the World Health Organization that demonstrates good sensitivity and specificity in many populations (past-month referent time period; score ≥ 8 for men or ≥ 6 for women)
* "Subthreshold or full PTSD," on the PTSD Checklist for DSM-5 (PCL-5), a 20-item measure of PTSD symptoms reliably used to monitor symptom change (past-month referent time period; "subthreshold" = meets at least two DSM-5 diagnostic categories (B, C, D, and/or E) at moderate or high severity)

Exclusion Criteria:

* Participation in concurrent formal psychotherapy (Note: Participants in all study conditions will be asked to refrain from concurrent formal psychotherapy. Participants who engage in formal psychotherapy outside of the research will be removed from the study at the point of treatment initiation. Outside treatment engagement will be queried at each assessment timepoint. If endorsed, the participant will be removed from the study at that timepoint, but data collected prior to treatment initiation will remain in the dataset. Aligning with the Seeking Safety model, Alcoholics Anonymous/Narcotics Anonymous/Dual Recovery Anonymous attendance will be encouraged; attendance will be tracked as a potential outcome mediator.)
* Members of the following special populations: Adults unable to consent; Individuals younger than 18 years; Prisoners; Pregnant women (Note: The investigators will not knowingly include pregnant women as participants; however, the investigators will not assess participants' pregnancy status.)

Where it's running

• University of Massachusetts Medical School
  Worcester, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Melissa L Anderson
• Email: melissa.anderson@umassmed.edu
• Phone: 508-856-5820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.