Brief Family-involved Treatment for Alcohol Use Disorder

NCT05545644 | Completed Results

• 1 other identifier: R34AA023304
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Use Disorder

Keywords

alcohol; treatment; brief intervention; family

Outcome Measures

Primary Outcomes (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.

  120 days

Secondary Outcomes (3)

• Drinker Inventory of Consequences (DrInC-2R)

  4 months

• Family Environment Scale (FES), Conflict Subscale

  4 months

• Family Environment Scale (FES) - Cohesion Subscale

  4 months

Study Arms (2)

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

EXPERIMENTAL

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

Treatment as Usual (TAU

ACTIVE COMPARATOR

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

Interventions

Brief Family-Involved Treatment for Alcohol Use Disorder BEHAVIORAL

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

Also known as: B-FIT

Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_; Treatment as Usual (TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• University of Massachusetts, Worcester: collaborator

Related Publications (1)

• 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.

  PMID: 36931829 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

Difficulties in establishing a site for recruitment, recruitment challenges, scheduling of baseline assessments and treatment sessions with family members, and large numbers of patients at the treatment facility leaving against medical advice, all resulted in a smaller number of participants than planned.

Results Point of Contact

• Title: Dr. Barbara McCrady
• Organization: University of New Mexico

bmccrady@unm.edu

505-925-2388

Study Officials

• Barbara S McCrady, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomly assigned, prospectively, to one of two study arms.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: April 1, 2015
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share