Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05545644 |
Other study ID # |
R34AA023304 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2015 |
Est. completion date |
May 30, 2019 |
Study information
Verified date |
September 2022 |
Source |
University of New Mexico |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
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
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.