N/A
Completed N=16
Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
Source: ClinicalTrials.gov NCT03845985 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment — -20.00; -11.11 percent drinking days per month — p=.838
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment |
-20.00; -11.11 | .838 |
| PRIMARY Change From Baseline Percent Drinking Days Per Month at One-month Follow-up |
-26.67; -13.33 | .620 |
| PRIMARY Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment |
17.78; -0.56 | .713 |
| PRIMARY Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up |
-23.33; -0.67 | .509 |
| PRIMARY Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment |
122.67; -9.17 | .491 |
| PRIMARY Change From Baseline Number of Drinks Per Month at One-month Follow-up |
-33.50; -22.90 | .715 |
| PRIMARY Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5 |
-0.30; -0.53 | .665 |
| PRIMARY Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5 |
-0.40; -0.22 | .875 |
| SECONDARY The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA) |
0.38; 0.05; -0.33; 0.00; 0.00; 0.00 | .610 |
| SECONDARY Penn Alcohol Craving Scale (PACS) |
1.33; -4.83 | .407 |
| SECONDARY Trauma Symptom Checklist - 40 (TSC-40) |
-0.22; -0.15 | .893 |
| SECONDARY Behavior and Symptom Identification Scale - 24 (BASIS-24) |
-0.16; .06 | .709 |
Eligibility Criteria
Inclusion Criteria
- Self-identification as a Deaf ASL user
- Age 18 or older
- Past-month alcohol consumption, as measured by the Alcohol Use Disorder Identification Test
- Subthreshold or full PTSD on the PTSD Checklist for DSM-5 (past-month referent time period; "subthreshold" = endorsement of at least two B-E criteria at a severity of "moderate" or higher)
- Ability to attend weekly study sessions at one of three study locations (Eastern, Central, or Western MA)
- Ability to access a videophone (the standard telecommunication device for the Deaf community)
Exclusion Criteria
- Participation in concurrent therapies (Note: Participants in both study conditions will be asked to refrain from concurrent formal psychotherapy; however, aligning with the Seeking Safety model, AA/NA/DRA attendance will be encouraged and attendance will be tracked as a potential outcome mediator).
- Members of the following special populations: Adults unable to consent; Individuals younger than 18; Prisoners; Pregnant women (Note: We will not knowingly include pregnant women as participants; however, we will not assess participants' pregnancy status.)
Exclusion criteria are intentionally minimal to recruit a diverse sample. Other behavioral health comorbidities (e.g., mood/anxiety disorders, substance use disorders other than AUD) will not be excluded, given high rates of comorbidity.
Data sourced from ClinicalTrials.gov (NCT03845985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.