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

This study is testing a new therapy toolkit called "Signs of Safety" for Deaf or hard-of-hearing individuals who experience problem drinking (Alcohol Use Disorder or AUD) and trauma (PTSD). This toolkit is designed to be used with an existing therapy called Seeking Safety, which helps with trauma and addiction. The study will compare this new approach to standard care provided by National Deaf Therapy. We are looking for 144 participants who are 18 or older, identify as Deaf or hard-of-hearing, and use American Sign Language (ASL). Success will be measured by changes in binge drinking days and PTSD severity after 12 weeks. The current recruitment status is unclear.

Study design
This study is an interventional trial planning to enroll 144 participants. It compares a new therapy toolkit with standard care.
What's involved
You would participate in therapy sessions and complete online surveys for study assessments. The main treatment period lasts 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured immediately after the 12-week treatment period.

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NCT06278922

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

Recruiting
NAAges 18+InterventionalTreatment
University of Massachusetts, Worcester
~144 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Seeking Safety + Signs of Safety toolkitTreatment as usual

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback
Measured over Change from baseline to immediate post-treatment at 12 weeks
+1 more outcome measured

Conditions

PTSD
Alcohol; Use, Problem

Explore related trials

Alcohol use disorderPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Melissa L Anderson
[email protected]
508-856-5820
Email the study team

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Eligibility criteria

Inclusion

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

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.)

What this trial measures

  • Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline FollowbackChange from baseline to immediate post-treatment at 12 weeks

    Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-treatment or 12 weeks as assessed by the Alcohol Timeline Followback

  • Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5Change from baseline to immediate post-treatment at 12 weeks

    Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.