Clinical trial NCT05545644: Brief Family-involved Treatment for Alcohol Use Disorder
Official title: : Developing a Brief Family-Involved Treatment for Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: alcohol
treatment
brief intervention
family
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2022-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomly assigned, prospectively, to one of two study arms.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria, Patient:

* 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.

Inclusion Criteria, Family:

* 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, Patient:

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

Exclusion Criteria, Family:

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

Primary outcomes:
measure: Form-90 Timeline Followback Interview
timeFrame: 120 days
Secondary outcomes:
measure: Drinker Inventory of Consequences (DrInC-2R)
timeFrame: 4 months
measure: Family Environment Scale (FES), Conflict Subscale
timeFrame: 4 months
measure: Family Environment Scale (FES) - Cohesion Subscale
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico
name: Barbara S McCrady, PhD
role: PRINCIPAL_INVESTIGATOR
References: