NCT03845985

Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

Completed NA Results posted Last updated 12 March 2024

What this trial tests

NA trial testing Seeking Safety + Signs of Safety toolkit in Alcohol Use Disorder in 16 participants. Completed in 31 July 2022.

Timeline

3 June 2019

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	3 June 2019
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Seeking Safety + Signs of Safety toolkit

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

University of Massachusetts, Worcester

Who can join

18 and older, any sex, with Alcohol Use Disorder or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment Primary · Change from baseline to immediate post-intervention at 12 weeks

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

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-20.00	± 29.06
Assessment-only Waitlist Control	-11.11	± 67.68

Change From Baseline Percent Drinking Days Per Month at One-month Follow-up Primary · Change from baseline to one-month follow-up at 16 weeks

Change from baseline percent drinking days per month (i.e., days with 1+ drink) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-26.67	± 37.71
Assessment-only Waitlist Control	-13.33	± 27.99

Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment Primary · Change from baseline to immediate post-intervention at 12 weeks

Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at immediate post-intervention or 12 weeks as assessed by Alcohol Timeline Followback

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	17.78	± 74.93
Assessment-only Waitlist Control	-0.56	± 1.36

Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up Primary · Change from baseline to one-month follow-up at 16 weeks

Change from baseline percent binge drinking days per month (i.e., days with 5+ drinks for men, 4+ for women) at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-23.33	± 33.00
Assessment-only Waitlist Control	-0.67	± 1.49

Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment Primary · Change from baseline to immediate post-intervention at 12 weeks

Change from baseline number of drinks per month at immediate post-treatment or 12 weeks as assessed by Alcohol Timeline Followback

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	122.67	± 272.56
Assessment-only Waitlist Control	-9.17	± 40.12

Change From Baseline Number of Drinks Per Month at One-month Follow-up Primary · Change from baseline to one-month follow-up at 16 weeks

Change from baseline number of drinks per month at one-month follow-up or 16 weeks as assessed by Alcohol Timeline Followback

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-33.50	± 47.38
Assessment-only Waitlist Control	-22.90	± 28.04

Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5 Primary · Change from baseline to immediate post-intervention at 12 weeks

Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-0.30	± 0.05
Assessment-only Waitlist Control	-0.53	± 0.86

Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5 Primary · Change from baseline to one-month follow-up at 16 weeks

Total Score on the PCL-5 divided by 20 items. Minimum score = 0; Maximum score = 4. Higher values represent more severe symptoms of PTSD.

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-0.40	± NA
Assessment-only Waitlist Control	-0.22	± 0.98

The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA) Secondary · Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up

All four subscales: Min. = 1, Max. = 4. Risk and Aggression/Liquid Courage/Sociability Subscale: Higher values indicate greater outcome expectancies of drinking alcohol on risk-taking, aggression, courage, and sociability. Self-Perception/Cognitive and Behavioral Impairment Subscale: Higher values indicate greater outcome expectancies on distorted self-perception and impaired behavior. Sexuality Subscale: Higher values indicate greater outcome expectancies on sexual behavior. Tension Reduction Subscale: Higher values indicate greater outcome expectancies on tension reduction.

Risk and Aggression/Liquid Courage/Sociability Subscale

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	0.38	± 1.19
Assessment-only Waitlist Control	0.05	± 0.73

Self-Perception/Cognitive and Behavioral Impairment Subscale

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-0.33	± 0.38
Assessment-only Waitlist Control	0.00	± 1.18

Sexuality Subscale

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	0.00	± 0.00
Assessment-only Waitlist Control	0.00	± 0.95

Tension Reduction Subscale

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	1.83	± 0.58
Assessment-only Waitlist Control	-0.17	± 0.82

Penn Alcohol Craving Scale (PACS) Secondary · Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up

Total score = sum of all 5 items. Minimum = 0; Maximum = 30. Higher values indicate higher severity of alcohol craving.

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	1.33	± 14.05
Assessment-only Waitlist Control	-4.83	± 7.62

Trauma Symptom Checklist - 40 (TSC-40) Secondary · Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up

Sum of all items divided by 40 items. Minimum = 0; Maximum = 3. Higher values indicate more severe trauma symptoms.

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-0.22	± 0.31
Assessment-only Waitlist Control	-0.15	± 0.83

Behavior and Symptom Identification Scale - 24 (BASIS-24) Secondary · Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up

Sum of all items divided by 24 items. Minimum = 0; Maximum = 4. Higher values indicate worsening behavior or more severe behavioral health symptoms.

Group	Value	95% CI
Seeking Safety + Signs of Safety Toolkit	-0.16	± 0.65
Assessment-only Waitlist Control	.06	± 0.22

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Psychotherapy research in the deaf community: pilot clinical trial lessons learned.
   Anderson ML, Wilkins AM, Hostovsky S, Pici-D'Ottavio E, et al · · 2025 · PMID 39887011 · DOI 10.1093/jdsade/enaf007