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Brief Family-involved Treatment for Alcohol Use Disorder (B-FIT)

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief Family-Involved Treatment for Alcohol Use Disorder
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol, treatment, brief intervention, family

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

    Treatment as Usual (TAU

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Form-90 Timeline Followback Interview
    Daily drinking data - proportion days abstinent

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 27, 2022
    Sponsor
    University of New Mexico
    Collaborators
    University of Massachusetts, Worcester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05545644
    Brief Title
    Brief Family-involved Treatment for Alcohol Use Disorder
    Acronym
    B-FIT
    Official Title
    : Developing a Brief Family-Involved Treatment for Alcohol Use Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    May 30, 2019 (Actual)
    Study Completion Date
    May 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of New Mexico
    Collaborators
    University of Massachusetts, Worcester

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    alcohol, treatment, brief intervention, family

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients randomly assigned, prospectively, to one of two study arms.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treatment as Usual (TAU
    Arm Type
    Active Comparator
    Arm Description
    Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief Family-Involved Treatment for Alcohol Use Disorder
    Other Intervention Name(s)
    B-FIT
    Intervention Description
    Up to 3 sessions of counseling involving a patient with alcohol use disorder and a concerned family member
    Primary Outcome Measure Information:
    Title
    Form-90 Timeline Followback Interview
    Description
    Daily drinking data - proportion days abstinent
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    TimeLine FollowBack Interview
    Description
    Daily drinking data - proportion days heavy drinking
    Time Frame
    4 months
    Title
    TimeLine FollowBack Interview
    Description
    Daily drinking data - drinks per drinking day
    Time Frame
    4 months
    Title
    Drinker Inventory of Consequences
    Description
    Negative consequences of drinking
    Time Frame
    4 months
    Title
    Commitment to Sobriety Scale
    Description
    Patient commitment to maintaining abstinence from alcohol
    Time Frame
    4 months
    Title
    Family Environment Scale, conflict and cohesion subscales
    Description
    Measure of patient and family member perception of conflict and cohesion in family
    Time Frame
    4 months
    Title
    FACES-IV communication scale
    Description
    Measure of patient and family member perception of family communication
    Time Frame
    4 months
    Title
    Beck Depression Inventory
    Description
    Measure of family member depression
    Time Frame
    1 week
    Title
    Beck Anxiety Inventory
    Description
    Measure of family member anxiety
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Brief Family-involved Treatment for Alcohol Use Disorder

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