Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma

NCT06278922 | Recruiting DMC

• 2 other identifiers: STUDY00001149R01AA031010
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD; Alcohol; Use, Problem

Outcome Measures

Primary Outcomes (2)

• 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

  Change from baseline to immediate post-treatment at 12 weeks

• 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.

  Change from baseline to immediate post-treatment at 12 weeks

Secondary Outcomes (23)

• Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback

  Change from baseline to immediate post-treatment at 12 weeks

• Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback

  Change from baseline to three-month follow-up at 25 weeks

• Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback

  Change from baseline to six-month follow-up at 38 weeks

• Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback

  Change from baseline to three-month follow-up at 25 weeks

• Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback

  Change from baseline to six-month follow-up at 38 weeks

Study Arms (3)

Seeking Safety + Signs of Safety toolkit

EXPERIMENTAL

Experimental participants will be offered 12 one-hour, weekly individual therapy sessions of Seeking Safety delivered with the Signs of Safety toolkit. Sessions will occur virtually via National Deaf Therapy's (NDT) secure HIPAA-compliant video chat platform. Length of treatment is limited to six months; number of completed sessions will be tracked as a measure of participant adherence.

Behavioral: Seeking Safety + Signs of Safety toolkit

Treatment as usual

ACTIVE COMPARATOR

Participants assigned to the active comparison condition will receive therapy as usual - i.e., general, open-ended, non-manualized supportive counseling provided by an NDT therapist. In the absence of any evidence-based therapies available for Deaf clients, this unstructured therapy approach is the current standard of care in the field of Deaf mental health. All NDT therapists are Deaf, fluent in ASL, and specialize in issues common to Deaf individuals seeking mental health care. Like the experimental condition, participants will receive 12 one-hour, weekly individual therapy sessions via NDT's secure virtual therapy platform. Length of treatment is limited to six months; number of completed sessions will be tracked as a measure of participant adherence.

Behavioral: Treatment as usual

No treatment

NO INTERVENTION

Participants in states with no NDT therapists and who prefer to be placed on NDT's waitlist instead of being referred outside of NDT for therapy will be automatically assigned to the no-treatment control condition. At the time of this submission, there are approximately 200 individuals on the NDT waitlist; individuals remain on the waitlist until a licensed therapist from their state joins the NDT team. Participants in the control condition will be prompted to complete assessments at baseline, week 6, week 12 (to approximate immediate post-treatment), week 25 (to approximate three-month follow-up), and week 38 (to approximate six-month follow-up). Such repeated assessment in the control arm will allow us to quantify and control for participants' natural change over time and any potential assessment reactivity.

Interventions

Seeking Safety + Signs of Safety toolkit BEHAVIORAL

Signs 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.

Seeking Safety + Signs of Safety toolkit

Treatment as usual BEHAVIORAL

NDT 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 as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Access to online survey technology for study assessments
• "Problematic alcohol consumption, drinking behaviors, and alcohol-related problems" on the AUD Identification Test (AUDIT), a 10-item screening measure developed by the World Health Organization that demonstrates good sensitivity and specificity in many populations (past-month referent time period; score ≥ 8 for men or ≥ 6 for women)
• "Subthreshold or full PTSD," on the PTSD Checklist for DSM-5 (PCL-5), a 20-item measure of PTSD symptoms reliably used to monitor symptom change (past-month referent time period; "subthreshold" = meets at least two DSM-5 diagnostic categories (B, C, D, and/or E) at moderate or high severity)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Melissa L Anderson

CONTACT

508-856-5820; melissa.anderson@umassmed.edu

Kayla Meza

CONTACT

kayla.meza@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI will be masked to study condition. All outcome data will be collected via online self-report surveys.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 26, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The investigators will submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award.
• Access Criteria: Can be accessed via the NIAAA Data Archive (NIAAADA)

Locations

US (1)