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AzTrials

Alcohol Use DisorderB-FITNCT05545644

Brief Family-involved Treatment for Alcohol Use Disorder

A study testing Brief Family-Involved Treatment for Alcohol Use Disorder in people with Alcohol Use Disorder, run by University of New Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Brief Family-Involved Treatment for Alcohol Use Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
1 Apr 2015to 30 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Brief Family-Involved Treatment for Alcohol Use Disorder
Keywords
alcohol, treatment, brief intervention, family
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Family-Involved Treatment for Alcohol Use DisorderBehavioural

    Also called B-FIT

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

Study groups in NCT05545644
Study groupRoleWhat they receive
Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ExperimentalUp 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.
Receives: Behavioral: Brief Family-Involved Treatment for Alcohol Use Disorder
Treatment as Usual (TAUActive comparatorTreatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities.
Receives: Behavioral: Brief Family-Involved Treatment for Alcohol Use Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 120 days

Secondary outcomes (3)

  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 4 months

  3. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start1 Apr 2015
  3. Primary completion30 May 2019
  4. Study completion30 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients randomly assigned, prospectively, to one of two study arms.
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545644
Sponsor's protocol ID
R34AA023304
Acronym
B-FIT
Status last verified
Apr 2024
First submitted
14 Sep 2022
Last updated
21 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36931829

Questions about this trial

What is this clinical trial studying?

A study testing Brief Family-Involved Treatment for Alcohol Use Disorder in people with Alcohol Use Disorder, run by University of New Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Form-90 Timeline Followback Interview (time frame: 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05545644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.

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