Brief Family-involved Treatment for Alcohol Use Disorder

Study Overview
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Brief Summary
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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
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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 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 ASAP 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.

Official Title
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: Developing a Brief Family-Involved Treatment for Alcohol Use Disorders

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Brief Family-Involved Treatment for Alcohol Use Disorder


Participation Criteria
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Eligibility Criteria
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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 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 SCID for DSM-IV 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomly assigned, prospectively, to one of two study arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_<br>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. | Behavioral: Brief Family-Involved Treatment for Alcohol Use Disorder<br>* Up to 3 sessions of counseling involving a patient with alcohol use disorder and a concerned family member<br>* Other names: B-FIT;|
| Active Comparator: Treatment as Usual (TAU<br>Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. | Behavioral: Brief Family-Involved Treatment for Alcohol Use Disorder<br>* Up to 3 sessions of counseling involving a patient with alcohol use disorder and a concerned family member<br>* Other names: B-FIT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Form-90 Timeline Followback Interview | Daily drinking data - proportion days abstinent | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TimeLine FollowBack Interview | Daily drinking data - proportion days heavy drinking | 4 months | 
| TimeLine FollowBack Interview | Daily drinking data - drinks per drinking day | 4 months | 
| Drinker Inventory of Consequences | Negative consequences of drinking | 4 months | 
| Commitment to Sobriety Scale | Patient commitment to maintaining abstinence from alcohol | 4 months | 
| Family Environment Scale, conflict and cohesion subscales | Measure of patient and family member perception of conflict and cohesion in family | 4 months | 
| FACES-IV communication scale | Measure of patient and family member perception of family communication | 4 months | 
| Beck Depression Inventory | Measure of family member depression | 1 week | 
| Beck Anxiety Inventory | Measure of family member anxiety | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, treatment, brief intervention, family