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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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 past-month alcohol consumption 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.

Official Title
-----------------
Piloting Signs of Safety: A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

Conditions
-----------------
Alcohol Use Disorder, Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Seeking Safety + Signs of Safety toolkit


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seeking Safety + Signs of Safety toolkit<br>Participants randomized to receive the intervention will be provided 12 one-hour weekly individual treatment sessions with one of four ASL-fluent study clinicians in Massachusetts. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. | Behavioral: Seeking Safety + Signs of Safety toolkit<br>* Seeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., Coping with Triggers, Asking for Help). Signs of Safety is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The 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.<br>|
| No Intervention: Assessment-only Waitlist Control<br>Participants randomized to the waitlist control condition will be offered the opportunity to receive the 12-session Seeking Safety + Signs of Safety toolkit intervention after an approximate 16 week waiting period. This 16 week waiting period is equivalent to the current waitlist to receive psychotherapy services through the PI's outpatient clinic. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment | Change from baseline percent drinking days per month (i.e., days with 1+ drink) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback | Change from baseline to immediate post-intervention at 12 weeks | 
| Change From Baseline Percent Drinking Days Per Month at One-month Follow-up | Change from baseline percent drinking days per month (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback | Change from baseline to one-month follow-up at 16 weeks | 
| Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment | Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback | Change from baseline to immediate post-intervention at 12 weeks | 
| Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up | Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback | Change from baseline to one-month follow-up at 16 weeks | 
| Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment | Change from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback | Change from baseline to immediate post-intervention at 12 weeks | 
| Change From Baseline Number of Drinks Per Month at One-month Follow-up | Change from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback | Change from baseline to one-month follow-up at 16 weeks | 
| Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by 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. | Change from baseline to immediate post-intervention at 12 weeks | 
| Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by 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. | Change from baseline to one-month follow-up at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA) | All four subscales: Min. = 1, Max. = 4. Risk and Aggression/Liquid Courage/Sociability Subscale: Higher values indicate greater outcome expectancies of drinking alcohol on risk-taking, aggression, courage, and sociability. Self-Perception/Cognitive and Behavioral Impairment Subscale: Higher values indicate greater outcome expectancies on distorted self-perception and impaired behavior. Sexuality Subscale: Higher values indicate greater outcome expectancies on sexual behavior. Tension Reduction Subscale: Higher values indicate greater outcome expectancies on tension reduction. | Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up | 
| Penn Alcohol Craving Scale (PACS) | Total score = sum of all 5 items. Minimum = 0; Maximum = 30. Higher values indicate higher severity of alcohol craving. | Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up | 
| Trauma Symptom Checklist - 40 (TSC-40) | Sum of all items divided by 40 items. Minimum = 0; Maximum = 3. Higher values indicate more severe trauma symptoms. | Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up | 
| Behavior and Symptom Identification Scale - 24 (BASIS-24) | Sum of all items divided by 24 items. Minimum = 0; Maximum = 4. Higher values indicate worsening behavior or more severe behavioral health symptoms. | Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychotherapy, trauma, addiction, Deaf