Piloting a Deaf Accessible Pre-Treatment for AUD

NCT ID: NCT07269119

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-08-31

Brief Summary

This pilot study will evaluate the feasibility, acceptability, and preliminary efficacy of an adaptation of Motivational Enhancement Therapy (MET) titled "DeafMET", intended for Deaf adults with high-risk alcohol use. In this single intervention cycle, 10 Deaf participants will receive the DeafMET intervention delivered either in-person or via telehealth. Primary outcomes include change in participants' stage of change regarding alcohol use and measures of recruitment, retention, satisfaction, and adherence. Findings will inform further refinement of the intervention and planning for future research.

Detailed Description

This study will conduct the first clinical pilot of DeafMET, a Deaf-accessible adaptation of Motivational Enhancement Therapy (MET) for alcohol use disorder (AUD) in Deaf adults. The U.S. Deaf community-over one million Americans who use American Sign Language (ASL)-experiences disproportionate rates of high-risk alcohol use and barriers to behavioral health care. Studies indicate that Deaf adults face significantly higher rates of lifetime problem drinking and are less likely to access evidence-based AUD treatment compared to their hearing peers. Unique challenges, such as limited English literacy, lack of available mental health resources in ASL, and low health literacy, contribute to poor health outcomes and marginalization within existing care systems.

While motivational interviewing and enhancement therapies are widely validated for treating substance use disorders in hearing populations, there are currently no evidence-based behavioral health interventions specifically adapted for Deaf individuals. Existing AUD treatments rely heavily on written English materials and verbal processing, limiting their accessibility and effectiveness among ASL users. Research demonstrates that Deaf people's average English reading level is at grade four, and health-related comprehension closely matches that of non-English-speaking immigrants. These disparities underscore the urgent need for linguistically and culturally tailored treatment protocols.

To address these barriers, the study team developed and refined the DeafMET prototype through comprehensive literature review, stakeholder input, and community engagement. The intervention features:

• Deaf-friendly client materials such as visual handouts revised for plain text and created with input from Deaf artists
• Translated ASL educational content
• Interactive components leveraging visual and narrative strategies that are accessible to Deaf clients with varied health literacy

The adaptation was developed in collaboration with Deaf clinicians, persons in recovery, and other stakeholders to maximize relevance, clarity, and engagement. The study design is a single-cycle pilot enrolling 30 Deaf adults who report past-month high-risk alcohol consumption and related problems. Recruitment will utilize networks within Deaf-serving organizations, behavioral health programs, and community outreach to ensure broad reach. Participants will receive the DeafMET intervention delivered by a Deaf therapist fluent in ASL. Sessions may be conducted in-person or remotely.

After meeting with the PI to determine study eligibility and provide informed consent, participants will complete the pre-intervention assessments. The participant will be sent a link to REDCap where they will complete a one-time demographic survey and 9 measures, estimated to take 1.5-2 hours. These measures have been translated into American Sign Language and participants will have access to both the ASL and written English versions of each measure.

Following completion of the pre-intervention measures, the DeafMET intervention will be administered either in-person or via Zoom. In-person sessions will be held in a private room in UMass Chan's Chang Building on the Shrewsbury campus. Choice of in-person or virtual sessions will depend on the potential participants' preference, location of residence, and transportation needs. Ideally, participants will be balanced across session format. In-person sessions will be conducted at the Chang Building on UMass' Shrewsbury campus in a private room designed for research purposes. Virtual sessions will be held either in the PI's office in the Chang Building or in another private room. There will be six sessions, each running for 1 hour, occurring on a biweekly basis. Participation in this trial is expected to last 13 weeks, inclusive of pre-intervention assessment and exit interview. Participants will be provided with an adapted psychotherapy intervention at no cost. The original intervention, MET, has been used successfully in both research and clinical settings with various populations since its inception in the 1990s. Adaptations were made to both the session structure and order as well as materials to better align with the needs of the deaf community. In addition, both the original MET and the current adaptation are designed to be brief interventions to be administered prior to other types of more intensive therapies or treatments, in order to boost internal motivation in recovery from AUD. If participants are interested in immediately starting long-term we will recommend they not participate in the study and instead provide resources to find local therapists who take their insurance. We can also provide the option to participate in the study while providing resources to start seeing a local therapist after they finish study participation.

All sessions will be recorded for consistency of session format. However, only 25% of each participant's sessions will be reviewed. The sessions will be reviewed for PI's fidelity to motivational interviewing principles using the Motivational Interviewing Competency Assessment (MICA) system. The research coordinator will receive training on the MICA coding system via the Motivational Interviewing Network of Trainers.

The first session will be the introductory session. The purpose of this session is to establish rapport, set the schema of MET and our work together, allow the client to share their reasons for coming and past experiences with therapy and/or recovery.

The 2nd session will be where the value card sort activity is completed. The purpose of this session is to complete the value card activity with the clients and answer any follow up questions from the first session. The focus of this session is to increase client's sense of empowerment and understanding of where they stand in life and start them thinking about the role alcohol plays in their life.

The 3rd and 4th sessions will be the assessment/interview sessions. The purpose of these sessions is to administer all of the assessments and interview questions that will be used to complete the personal feedback report.

In between the 3rd and 4th sessions, the participant will complete the mid-intervention assessments. They will again be sent a link to REDCap where they will complete the same 9 measures as the pre-intervention assessment.

The 5th session is where the personal feedback report will be reviewed. The purpose of this session is to review progress, share the Personal Feedback Report (PFR) based on prior assessments, and begin transitioning into Phase 2 of MET: strengthening commitment to change. If the client is interested, a partner or support person may join to provide their perspective and support.

The 6th and final session is to deepen the conversation. This session serves to deepen exploration of motivation, especially if the client is still ambivalent or has not yet committed to change. It offers space to continue reflecting on feedback, life goals, and the role of alcohol. For clients already engaging in change, the session can support ongoing commitment and planning.

After completing the 6th session, the participant will again be sent a link to REDCap where they will complete the same 9 measures as the pre- and mid-intervention assessment. In addition, the research coordinator will complete a semi-structured qualitative interview with each participant to elicit their feedback on all parts of the DeafMET intervention.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm: Deaf-MET Intervention

Participants in the experimental arm will receive Deaf-MET, a culturally and linguistically accessible adaptation of Motivational Enhancement Therapy (MET) for Deaf adults with high-risk alcohol use. MET is a client-centered counseling approach that enhances motivation for change by exploring and resolving ambivalence, using reflective listening, feedback, and collaborative goal-setting. Deaf-MET will be delivered in American Sign Language and incorporates visual handouts, plain language materials, and filmed educational content adapted from the original MET protocol into ASL teaching stories. Sessions are offered in-person or via telehealth.

Group Type: EXPERIMENTAL

Deaf-MET

Intervention Type: BEHAVIORAL

Deaf-MET is a culturally and linguistically accessible adaptation of Motivational Enhancement Therapy (MET) for Deaf adults with high-risk alcohol use

Interventions

Deaf-MET

Deaf-MET is a culturally and linguistically accessible adaptation of Motivational Enhancement Therapy (MET) for Deaf adults with high-risk alcohol use

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• self-identification as a Deaf ASL user
• age 18+
• ability to access Zoom for screening, intervention delivery, and repeated assessment procedures
• problematic alcohol consumption, drinking behaviors, and alcohol-related problems" as identified by the AUD Identification Test (AUDIT), past-month referent time period: score at least 8 for men or at least 6 for women

Exclusion Criteria

• Incapacity to consent due to guardianship or conservatorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Alexander Wilkins

Assistant Professor, Dept of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Wilkins, PhD, MSCI

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Central Contacts

Alexander Wilkins, PhD, MSCI

Role: CONTACT

alexander.wilkins@umassmed.edu

508-556-6261

Other Identifiers

K23AA029466

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002259

Identifier Type: -

Identifier Source: org_study_id