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
Qualifiers
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
Treatments tested in this trial
- Seeking Safety + Signs of Safety toolkit
- Treatment as usual
Treatment groups
144 Participants
are divided into 3 treatment groupsLocations
1University of Massachusetts Medical School01655, WorcesterMassachusetts, United States
Sponsors and collaborators
University of Massachusetts, Worcester
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov