Brief Family-involved Treatment for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— B-FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545644
• Other study ID #: R34AA023304
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: May 30, 2019

Study information

• Verified date: April 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	University of Massachusetts, Worcester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Form-90 Timeline Followback Interview	The Timeline Followback (TLFB) Interview is one section of a larger interview designed to measures outcomes of alcohol treatment. An interviewer uses a calendar to elicit information from the participant about the amount of alcohol consumed on each day within the time period of interest (3 months prior to the interview at baseline; 4 months from baseline at the follow-up interview). From the daily drinking data on the calendar, the interviewer counts the number of days abstinent, and divides that by the total number of days covered in the interview to generate a single value - proportion of days abstinent. This value can range from 0-100. A family member also was interviewed to provide the same data at follow-up. If follow-up data were unavailable from the participant, the family member report was used. Proportion of days abstinent is the outcome variable of interest. Higher values reflect a more positive outcome.	120 days
Secondary	Drinker Inventory of Consequences (DrInC-2R)	The DrInC-2R is a 45-item self-report of negative consequences of drinking. Respondents report how often each of 45 different potential negative consequences of drinking has occurred, using a 4-point scale ranging from 0 (never) to 3 (almost daily). Higher scores reflect a higher number and frequency of negative consequences. Total scores can range from 0-135.	4 months
Secondary	Family Environment Scale (FES), Conflict Subscale	The Conflict subscale of the FES is a measure the amount of openly expressed anger and conflict among family members. Respondents answer "true" or "false" to each of the nine items on the scale. After the nine items are totaled, the score is converted to a standard score, which ranges from 33-80, based on the norms in the manual. Higher scores indicate more perceived anger and conflict in the family. The Conflict (and Cohesion) were the only FES subscales administered.	4 months
Secondary	Family Environment Scale (FES) - Cohesion Subscale	The Cohesion subscale of the FES is a measure of the respondent's perception of the degree of commitment, help, and support family members provide for one another. Respondents answer "true" or "false" to each of the nine items on the scale. After the nine items are totaled, the score is converted to a standard score, which ranges from 4-65 based on the norms in the manual. Higher scores indicate more perceived cohesion in the family. The Cohesion (and Conflict) subscales were the only subscales from the FES.	4 months