NCT07269119

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

November 18, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

alcohol use disorderdeaf

Outcome Measures

Primary Outcomes (2)

  • University of Rhode Island Change Assessment

    URICA measures a patient's readiness to change using a self-reported questionnaire that categorizes the patient into one of the 4 following stages: precontemplation, contemplation, action, or maintenance. Potential scores range from -2 to 14. Scores below 8 indicate precontemplation. Scores between 8-11 indicate contemplation. Scores above 11 indicate preparation or action stage.

    From enrollment to end of participation at 3 months

  • Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A)

    The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) is an instrument designed to assess motivation for change in problem drinkers. There are three scales: Recognition (score range 7-35), Ambivalence (score range 4-20), and Taking Steps (score range 8-40). For all scales, a higher score is better in that they 1) recognize they have a drinking problem, 2) are thinking about their drinking's effect on people, and 3) are actively taking steps to change.

    From enrollment to end of treatment at 3 months

Secondary Outcomes (7)

  • Alcohol Use Disorders Identification Test

    From enrollment to end of treatment at 3 months

  • Alcohol Timeline Followback

    From enrollment to end of treatment at 3 months

  • Comprehensive Effects of Alcohol- Brief

    From enrollment to end of treatment at 3 months

  • Penn Alcohol Craving Scale

    From enrollment to end of treatment at 3 months

  • California Psychotherapy Alliance Scale

    From enrollment to end of treatment at 3 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Client Exit Interview

    Upon completion of treatment at 13 weeks

Study Arms (1)

Experimental Arm: Deaf-MET Intervention

EXPERIMENTAL

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.

Behavioral: Deaf-MET

Interventions

Deaf-METBEHAVIORAL

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

Experimental Arm: Deaf-MET Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Incapacity to consent due to guardianship or conservatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Chan

Shrewsbury, Massachusetts, 01545, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alexander Wilkins, PhD, MSCI

    UMass Chan Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Wilkins, PhD, MSCI

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dept of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 8, 2025

Study Start

February 5, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The investigators will submit and share data with the NIAAA Data Archive, a data repository housed within the National Institute on Mental Health (NIMH) Data Archive (NDA), per the requirements set forth in NOT-AA-23-002 (grants.nih.gov/grants/guide/notice-files/NOT-AA-23-002.html). All data will be de-identified before submission to the data archive.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The investigators will submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award.
Access Criteria
Can be accessed via the NIAAA Data Archive (NIAAADA)
More information

Locations