Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
The U.S. Deaf community - a group of more than one million Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Seeking Safety + Signs of Safety toolkit
BehavioralSigns of Safety is a Deaf-accessible toolkit to be used with the Seeking Safety treatment protocol. Seeking Safety is a manualized, non-exposure-based, cognitive behavioral therapy for trauma and addiction.
Treatment as usual
BehavioralNDT therapists come from a wide variety of training backgrounds, but each works with their clients to build on their existing strengths and provide support as clients develop new strategies and behaviors for overcoming adversity.
Treatment groups
144 Participants
are divided into 3 treatment groupsGroup A: Seeking Safety + Signs of Safety toolkitExperimental treatment 1 intervention
Group B: Treatment as usualActive comparator 1 intervention
Group C: No treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback
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
Time frame
Change from baseline to immediate post-treatment at 12 weeks2
Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5
Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.
Time frame
Change from baseline to immediate post-treatment at 12 weeksSecondary outcomes
1
Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at immediate post-treatment or 12 weeks as assessed by the Alcohol Timeline Followback
Time frame
Change from baseline to immediate post-treatment at 12 weeks2
Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at three-month follow-up or 25 weeks as assessed by the Alcohol Timeline Followback
Time frame
Change from baseline to three-month follow-up at 25 weeks3
Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback
Change from baseline percent drinking days per month (i.e., days with 1+ drink) at six-month follow-up or 38 weeks as assessed by the Alcohol Timeline Followback
Time frame
Change from baseline to six-month follow-up at 38 weeks4
Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback
Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at three-month follow-up or 25 weeks as assessed by the Alcohol Timeline Followback
Time frame
Change from baseline to three-month follow-up at 25 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov