Brief Family-involved Treatment for Alcohol Use Disorder

NCT ID: NCT05545644

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2019-05-30

Brief Summary

Family-involved treatments for alcohol use disorders (AUDs) hold considerable promise to improve engagement and compliance with treatment and improve treatment outcomes. Currently, however, these treatments are time-intensive and difficult to learn and to integrate with on-going clinical treatment. Consistent with the general trend toward briefer treatments, we propose to develop a brief, 3-session, family-involved treatment that can be incorporated into a variety of other AUD treatment modalities. If successful, the treatment may increase the efficiency and effectiveness of AUD treatment.

Detailed Description

The overall aim of this treatment development study is to develop an efficacious, brief, family-involved treatment that can be used flexibly in on-going alcohol treatment settings to advance the dissemination of evidence-based treatment. The treatment to be developed and tested in this grant, "B-FIT" (Brief Family-Involved Treatment), builds on the PI's earlier National Institute on Alcohol Abuse and Alcoholism (NIAAA)-supported efficacy trials and studies of mechanisms of change in Alcohol Behavioral Couple Therapy (ABCT) and is designed as an add-on to community-based substance abuse treatment-as-usual (TAU). B-FIT uses family involvement to enhance patient treatment adherence and outcomes by improving family functioning and increasing family-provided incentives for treatment adherence and abstinence. Study aims are carefully sequenced to develop the B-FIT approach and to judge its merits through a rigorous set of fidelity analyses, a small-scale clinical trial, and prospective tests of potential active ingredients, mediators, and moderators of treatment response. Specific are to: (1) modify ABCT to make it (a) appropriate for any concerned family member, (b) shorter, (c) focused on key mechanisms of change, (d) appropriate for use as part of an on-going alcohol treatment program, and (e) more efficacious by incorporating behavioral contracting procedures; (2) conduct a small-scale clinical trial of B-FIT; and (3) finalize materials for a larger-scale RCT. To accomplish study aims, a stage 1A successive cohort treatment development approach followed by a stage 1B small randomized clinical trial (RCT) will be completed. In the 1A stage, key interventions in B-FIT will be identified and integrated into the preliminary version of the treatment manual. Then, in the 1B stage B-FIT will be tested in an RCT to determine feasibility and preliminary efficacy. The project includes six phases: (1) focus groups with service providers, patients, and concerned family members (CFMs) of patients to obtain feedback about the B-FIT content and materials; (2) modification of the B-FIT protocol in response to the focus group feedback; (3) clinician training in the B-FIT protocol followed by pilot testing with six patients and their CFMs. Each clinician, patient, and CFM will be debriefed after the treatment to assess the B-FIT intervention. (4) Further modifications to the B-FIT materials in response to feedback from the pilot study as well as a second set of focus groups used to obtain feedback on the B-FIT written materials in terms of readability, relevance, and ease of use. (5) Structured didactic and experiential training for clinicians on the B-FIT treatment. (6) A small-scale, randomized clinical trial of TAU versus B-FIT + TAU will be conducted with 60 patients and their CFMs to (a) test the feasibility of B-FIT and impact on patient treatment retention, (b) obtain effect size estimates for pre-post changes in drinking, CFM, and family functioning; (c) assess therapist fidelity; (d) measure hypothesized active ingredients in the treatment; and (e) conduct initial moderator analyses. In parallel with phases 1-5 all measures and study procedures will be finalized. Three-month follow-up data will be collected as part of the clinical trial.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_

Up to 3 sessions of family-involved treatment for patients with alcohol use disorder (AUD) and a family member: Session 1; psychoeducation; increasing supportive behaviors, enhancing positive activities. Session 2: Improving communication; recovery contracts. Session 3: Review of session1 \& 2 interventions; continue with communication skills.

Group Type: EXPERIMENTAL

Brief Family-Involved Treatment for Alcohol Use Disorder

Intervention Type: BEHAVIORAL

Up to 3 sessions of counseling involving a patient with alcohol use disorder and a concerned family member

Treatment as Usual (TAU

Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities.

Group Type: ACTIVE_COMPARATOR

Brief Family-Involved Treatment for Alcohol Use Disorder

Intervention Type: BEHAVIORAL

Up to 3 sessions of counseling involving a patient with alcohol use disorder and a concerned family member

Interventions

Brief Family-Involved Treatment for Alcohol Use Disorder

Up to 3 sessions of counseling involving a patient with alcohol use disorder and a concerned family member

Intervention Type: BEHAVIORAL

Other Intervention Names

B-FIT

Eligibility Criteria

Inclusion Criteria

• Having a family member rated as important, very important or extremely important
• Score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
• Negative responses to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) psychotic screener (no to all questions or if any positive symptoms occurred only in the context of substance use)
• Negative responses to a two-question domestic violence screener.

• Willing to participate in the study
• AUDIT < 8
• Negative responses to the Structured Clinical Interview for DSM-IV (SCID) psychotic screener
• Negative on a domestic violence screener

Exclusion Criteria

• No available important family member
• Score < 8 on AUDIT
• Current psychotic features
• Current domestic violence

• Unwilling to participate
• Score of 8 or higher on AUDIT
• Current psychotic features
• Current domestic violence

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

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara S McCrady, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

References

McCrady BS, Tonigan JS, Fink BC, Chavez R, Martinez AD, Borders A, Fokas K, Epstein EE. A randomized pilot trial of brief family-involved treatment for alcohol use disorder: Treatment engagement and outcomes. Psychol Addict Behav. 2023 Nov;37(7):853-862. doi: 10.1037/adb0000912. Epub 2023 Mar 16.

Reference Type: DERIVED

PMID: 36931829 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34AA023304

Identifier Type: NIH

Identifier Source: org_study_id

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