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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Massachusetts
University of Massachusetts Medical School
RECRUITING
Worcester
Contact Information
Primary
Melissa L Anderson
melissa.anderson@umassmed.edu
508-856-5820
Backup
Kayla Meza
kayla.meza@umassmed.edu
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 144
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Leads: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov