Evaluating "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

The U.S. Deaf community - 500,000+ Americans who communicate using American Sign Language
(ASL) - experiences nearly triple the rate of lifetime problem drinking compared to the
general population and twice the rate of trauma exposure. Although there are validated
treatments for comorbid alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD)
in hearing populations, there are no evidence-based treatments to treat any behavioral health
condition with Deaf clients. Current treatments fail to meet Deaf clients' unique linguistic
and cultural needs. Deaf people's median English reading level falls at the fourth grade, and
many have low health literacy due to reduced incidental learning (e.g., inability to
communicate with hearing parents, overhear family conversations, or understand spoken health
information on TV/radio/public service announcements). Written treatment materials,
therefore, require plain text revisions, ASL translations, or ASL narrative storytelling.
Equally important are materials that incorporate Deaf values and social norms, increasing
clinicians' cultural competence and enhancing client engagement.

To address these barriers, the Principal Investigator conducted a pilot study to develop a
prototype of "Signs of Safety": a Deaf-accessible toolkit to be used alongside a
widely-disseminated protocol for addiction/PTSD - Seeking Safety. Seeking Safety has
demonstrated efficacy for reduction of AUD and PTSD symptoms in hearing populations. Among
available evidence-based protocols, "Seeking Safety" is the optimal choice to adapt for Deaf
clients - its focus on simple coping skills that simultaneously target AUD and PTSD (or
either alone) is an ideal match for Deaf people's language and learning deficits, which
prohibit use of verbal problem-solving and cognitive processing strategies that other
psychotherapies require. Yet, Seeking Safety's client materials rely on written English and
are not well understood by Deaf clients. As such, the "Signs of Safety" toolkit includes a
therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching
stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing
clinicians working with ASL interpreters.

Data from the Principal Investigator's "Signs of Safety" single-arm pilot study (n = 13) show
significant reductions in alcohol use frequency and PTSD severity from baseline to immediate
post-treatment follow-up. Participants also reported high levels of satisfaction with the
model, and provided detailed feedback about how to further improve "Signs of Safety" for a
professional-quality, second iteration. The proposed study builds upon the Principal
Investigator's pilot work by generating a final, professional iteration of Signs of Safety to
be used in future efficacy work. Based on pilot results, the study team created a second
iteration of the "Signs of Safety" toolkit, including re-filming ASL teaching stories,
re-designing visual handouts, and revising the therapist companion guide. The study team will
then develop a training program for "Signs of Safety" and certify four study clinicians.

The study team proposes to conduct a two-arm pilot RCT of "Signs of Safety". The study team
aims to enroll 60 Deaf adults with past-month PTSD and high-risk alcohol consumption,
drinking behaviors, and alcohol-related problems to participate in 12 weekly individual
treatment sessions. The pilot RCT will compare the 12-session protocol of Seeking Safety +
"Signs of Safety" toolkit with an assessment-only waitlist control. Across conditions,
assessment will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and
one-month follow-up/week 16. The study team will analyze key aspects of feasibility for both
study arms (e.g., recruitment, retention, assessment process). Primary clinical outcomes at
immediate post-treatment and one-month follow-up are past 30-day alcohol use
frequency/quantity and past 30-day PTSD severity. Exploratory analyses will be conducted to
examine potential moderators and mediators of change (e.g., motivation for treatment,
provider cultural competency, coping skills, self-compassion, understanding of health
information) leading to positive outcome. Results from this study will produce feasibility
and preliminary efficacy data to support for a full-scale RCT to evaluate "Signs of Safety",
and a community-engaged model for conducting RCTs with Deaf participants.

Inclusion Criteria:

- Self-identification as a Deaf ASL user

- Age 18 or older

- Problematic alcohol consumption, drinking behaviors, and alcohol-related problems
(past-month referent time period; Alcohol Use Disorder Identification Test score ≥ 8
for men or ≥ 6 for women)

- 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.