Trial Outcomes & Findings for Brief Family-involved Treatment for Alcohol Use Disorder (NCT NCT05545644)

Last Updated: 2024-05-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

120 days

Results posted on

2024-05-21

Participant Flow

Participants were recruited from a publicly funded inpatient substance use disorder treatment program.

Participant milestones

Participant milestones
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ 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. 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	Treatment as Usual (TAU Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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
Overall Study STARTED	18	17
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ 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. 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	Treatment as Usual (TAU Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

Brief Family-involved Treatment for Alcohol Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ n=18 Participants 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. 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	Treatment as Usual (TAU n=17 Participants Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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	Total n=35 Participants Total of all reporting groups
Age, Continuous	42.06 years STANDARD_DEVIATION 10.14 • n=5 Participants	44.65 years STANDARD_DEVIATION 9.49 • n=7 Participants	43.31 years STANDARD_DEVIATION 9.77 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants
Alcohol Use Disorders Identification Test (AUDIT)	33.88 units on a scale STANDARD_DEVIATION 5.12 • n=5 Participants	33.53 units on a scale STANDARD_DEVIATION 5.69 • n=7 Participants	33.71 units on a scale STANDARD_DEVIATION 5.33 • n=5 Participants
Timeline Followback Interview	.35 Proportion of days abstinent STANDARD_DEVIATION .33 • n=5 Participants	.19 Proportion of days abstinent STANDARD_DEVIATION .31 • n=7 Participants	.27 Proportion of days abstinent STANDARD_DEVIATION .33 • n=5 Participants
Family Environment Scale - conflict subscale	5.56 Units on a scale STANDARD_DEVIATION 8.00 • n=5 Participants	5.18 Units on a scale STANDARD_DEVIATION 2.16 • n=7 Participants	5.37 Units on a scale STANDARD_DEVIATION 1.73 • n=5 Participants
Family Environment Scale - cohesion subscale	3.61 units on a scale STANDARD_DEVIATION 1.29 • n=5 Participants	3.18 units on a scale STANDARD_DEVIATION 1.16 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 1.22 • n=5 Participants

PRIMARY outcome

Timeframe: 120 days

Population: Report of proportion days abstinent based on combined reports of patients and a significant other. Data were not available for 4 participants in the B-FIT condition, and 5 participants in the TAU condition, resulting in a follow-up sample of 14 in B-FIT and 12 in TAU.

Outcome measures

Outcome measures
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ n=14 Participants 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. 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	Treatment as Usual (TAU n=12 Participants Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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
Form-90 Timeline Followback Interview	.78 proportion of days abstinent Standard Deviation .06	.64 proportion of days abstinent Standard Deviation .10

SECONDARY outcome

Timeframe: 4 months

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.

Outcome measures

Outcome measures
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ n=11 Participants 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. 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	Treatment as Usual (TAU n=11 Participants Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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
Drinker Inventory of Consequences (DrInC-2R)	18.82 units on a scale Standard Deviation 4.76	12.71 units on a scale Standard Deviation 4.52

SECONDARY outcome

Timeframe: 4 months

Population: Participants who completed the measure (11/18 in B-FIT) (11/17 in TAU)

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.

Outcome measures

Outcome measures
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ n=11 Participants 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. 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	Treatment as Usual (TAU n=11 Participants Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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
Family Environment Scale (FES), Conflict Subscale	5.45 units on a scale Standard Deviation .47	5.64 units on a scale Standard Deviation .35

SECONDARY outcome

Timeframe: 4 months

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.

Outcome measures

Outcome measures
Measure	Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT_ n=11 Participants 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. 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	Treatment as Usual (TAU n=11 Participants Treatment as usual in inpatient AUD rehabilitation program, including daily therapy groups, individual counseling, and health and recreational activities. 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
Family Environment Scale (FES) - Cohesion Subscale	2.91 units on a scale Standard Deviation .37	3.45 units on a scale Standard Deviation .37

Adverse Events

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual (TAU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barbara McCrady

University of New Mexico

Phone: 505-925-2388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place