A Deaf-accessible therapy toolkit for treating alcohol use disorder and trauma
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
This study is testing a new therapy toolkit designed for Deaf individuals to see if it helps them better manage alcohol use disorder and trauma compared to standard treatment and no treatment at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06278922 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Deaf or hard-of-hearing individuals aged 18 and older who are proficient in American Sign Language and meet the criteria for problematic alcohol consumption and PTSD.
Not a fit: Patients who do not identify as Deaf or hard-of-hearing, or those who do not meet the specified criteria for alcohol use and PTSD, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a tailored therapeutic approach that significantly improves treatment outcomes for Deaf individuals suffering from AUD and PTSD.
How similar studies have performed: While there have been no previous studies specifically targeting the Deaf community for AUD and PTSD, the approach of developing tailored interventions for underserved populations has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Worcester, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.