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

NCT03845985 | Completed Results DMC

• 2 other identifiers: H00016364R34AA026929
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Post Traumatic Stress Disorder

Keywords

psychotherapy; trauma; addiction; Deaf

Outcome Measures

Primary Outcomes (8)

• Change From Baseline Percent Drinking Days Per Month at Immediate Post-Treatment

  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

  Change from baseline to immediate post-intervention at 12 weeks

• Change From Baseline Percent Drinking Days Per Month at One-month Follow-up

  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

  Change from baseline to one-month follow-up at 16 weeks

• Change From Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment

  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

  Change from baseline to immediate post-intervention at 12 weeks

• Change From Baseline Percent Binge Drinking Days Per Month at One-month Follow-up

  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

  Change from baseline to one-month follow-up at 16 weeks

• Change From Baseline Number of Drinks Per Month at Immediate Post-Treatment

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

  Change from baseline to immediate post-intervention at 12 weeks

• Change From Baseline Number of Drinks Per Month at One-month Follow-up

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

  Change from baseline to one-month follow-up at 16 weeks

• Change From Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Assessed by PCL-5

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

  Change from baseline to immediate post-intervention at 12 weeks

• Change From Baseline Past 30-day PTSD Severity at One-month Follow-up as Assessed by PCL-5

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

  Change from baseline to one-month follow-up at 16 weeks

Secondary Outcomes (4)

• The Brief Comprehensive Effects of Alcohol Questionnaire (B-CEOA)

  Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up

• Penn Alcohol Craving Scale (PACS)

  Baseline/Pre-intervention, Week 4, Week 8, Week 12/Post-intervention, and Week 16/One-month Follow-up

• Trauma Symptom Checklist - 40 (TSC-40)

  Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up

• Behavior and Symptom Identification Scale - 24 (BASIS-24)

  Baseline/Pre-Intervention, Week 12/Post-Intervention, Week 16/One-month Follow-up

Study Arms (2)

Seeking Safety + Signs of Safety toolkit

EXPERIMENTAL

Participants randomized to receive the intervention will be provided 12 one-hour weekly individual treatment sessions with one of four ASL-fluent study clinicians in Massachusetts. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16.

Behavioral: Seeking Safety + Signs of Safety toolkit

Assessment-only Waitlist Control

NO INTERVENTION

Participants randomized to the waitlist control condition will be offered the opportunity to receive the 12-session Seeking Safety + Signs of Safety toolkit intervention after an approximate 16 week waiting period. This 16 week waiting period is equivalent to the current waitlist to receive psychotherapy services through the PI's outpatient clinic. Assessments will occur at baseline, week 4, week 8, immediate post-treatment/week 12, and one-month follow-up/week 16.

Interventions

Seeking Safety + Signs of Safety toolkit BEHAVIORAL

Seeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., "Coping with Triggers," "Asking for Help"). "Signs of Safety" is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters.

Seeking Safety + Signs of Safety toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identification as a Deaf ASL user
• Age 18 or older
• Past-month alcohol consumption, as measured by the Alcohol Use Disorder Identification Test
• Subthreshold or full PTSD on the PTSD Checklist for DSM-5 (past-month referent time period; "subthreshold" = endorsement of at least two B-E criteria at a severity of "moderate" or higher)
• Ability to attend weekly study sessions at one of three study locations (Eastern, Central, or Western MA)
• Ability to access a videophone (the standard telecommunication device for the Deaf community)

You may not qualify if:

• Participation in concurrent therapies (Note: Participants in both study conditions will be asked to refrain from concurrent formal psychotherapy; however, aligning with the Seeking Safety model, AA/NA/DRA attendance will be encouraged and attendance will be tracked as a potential outcome mediator).
• Members of the following special populations: Adults unable to consent; Individuals younger than 18; Prisoners; Pregnant women (Note: We will not knowingly include pregnant women as participants; however, we will not assess participants' pregnancy status.)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• Heffernan K. Seeking Safety: A Treatment Manual for PTSD and Substance Abuse. Psychother Res. 2003 Mar;13(1):125-6. doi: 10.1080/713869629. No abstract available.

  PMID: 22475169 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic; Wounds and Injuries; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Limitations and Caveats

This trial began recruiting in mid-2019. Just as enrollment ramped up, our trial was disrupted by the onset of the COVID-19 pandemic. We paused the study to overhaul our in-person research methods and learn how to implement a virtual clinical trial - an acceleration of the inevitable development needed to scale to a national level. Due to these disruptions, our sample size was small and resulting analyses were significantly underpowered.

Results Point of Contact

• Title: Melissa L. Anderson, Associate Professor of Psychiatry
• Organization: UMass Chan Medical School

melissa.anderson@umassmed.edu

508-856-5820

Study Officials

• Melissa L Anderson, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to one of two conditions: (1) Seeking Safety + Signs of Safety toolkit, or (2) assessment-only waitlist control. Randomization will occur within each study site and stratified by gender. The Biostatistician will generate a computerized random number series and place numbers in individual sealed opaque envelopes. The RC will open an envelope to randomly assign a treatment condition to the participant. Both the PI and Co-I/Outcomes Assessor will be blind to study condition. (Note: the Co-I/Outcomes Assessor will remain blind to study condition until the end of the post-treatment assessment, at which point she will administer a client satisfaction measure that will unblind the Co-I to which subjects are in the waitlist control group.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 19, 2019
• Study Start: June 3, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 12, 2024
• Results First Posted: September 29, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee may use the data for individual participant data meta-analysis.

Locations

US (1)