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

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06278922
Status
Recruiting
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Conditions

  • Alcohol; Use, Problem
  • PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 23, 2024
Status verified
Jun 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Seeking Safety + Signs of Safety toolkit
    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.
  • Active Comparator: Treatment as usual
    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.
  • No Intervention: No treatment
    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.

Primary Outcome Measure

Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback [ Time Frame: Change from baseline to immediate post-treatment at 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Medical SchoolWorcesterMassachusetts01655
Melissa L Anderson, PhD
[email protected]
508-856-5820

Find similar trials in Worcester, MA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Massachusetts Medical School· Worcester, MA

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