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NCT03845985 · ClinicalTrials.gov registry record · NA
Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma
A NA study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03845985: Completed NA study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by University of Massachusetts, Worcester.
NCT03845985 is a NA study of Post Traumatic Stress Disorder and Alcohol Use Disorder that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 16 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845985, a NA study of Post Traumatic Stress Disorder and Alcohol Use Disorder, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Seeking Safety + Signs of Safety toolkit
Study Locations (1)
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2022-07-31 |
| Phase | NA |
What the finished NCT03845985 record still lists
NCT03845985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Seeking Safety + Signs of Safety toolkit is the first listed.
NCT03845985 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03845985 about?
NCT03845985 is a clinical study titled "Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma". 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 ...
What is the current status of trial NCT03845985?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2019-06-03. Estimated completion is 2022-07-31.
What conditions does trial NCT03845985 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Alcohol Use Disorder.
What interventions are being tested in trial NCT03845985?
The interventions under investigation include: Seeking Safety + Signs of Safety toolkit (BEHAVIORAL).
Who is sponsoring clinical trial NCT03845985?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03845985 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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16 245th of 262 higher than 16 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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