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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Start date: Dec 2, 2024 to Dec 23, 2024v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v5
  4. Notable Primary endpoints: 12 to 2
    • Secondary endpoints: 13 to 23
    • Study description expanded, about 5 words
    v4
  5. Minor Start date: Nov 18, 2024 to Dec 2, 2024v3
  6. Notable Start date: Sep 30, 2024 to Nov 18, 2024
    • Primary and study completion dates: Sep 30, 2028 to Nov 30, 2028
    • Eligibility criteria expanded, about 2 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06278922
Lead Sponsor University of Massachusetts, Worcester
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)
PTSD, Alcohol; Use, Problem
Related terms Alcoholism, Stress Disorders, Post-Traumatic
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov