NCT01546025

Brief Summary

This is a 2-year research project to test the efficacy of brief motivational intervention for reducing heavy alcohol use in young adults transitioning out of high school. Participation occurs within 3 months prior to graduation or within 1 year following graduation or dropout from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session of BMI or one session of relaxation training. All participants complete identical assessments at baseline and immediately post-intervention (during session 1). Participants also complete in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators (person-level predictors) of intervention response; and c) identifying mediators (mechanisms) of intervention effects, that is, how BMI exerts its effect on outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
13 years until next milestone

Results Posted

Study results publicly available

March 5, 2025

Completed
Last Updated

June 12, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

February 20, 2012

Results QC Date

February 12, 2025

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timeline Follow Back Assessing Number of Standard Drinks

    This is a calculation of the number of standard alcohol drinks consumed per week, based on data collected via the timeline follow back interview

    3 months

Secondary Outcomes (6)

  • Brief Young Adult Alcohol Consequences Questionnaire

    6 week and 3 month follow ups

  • Help Seeking

    6 week and 3 month follow ups

  • Drinking Reduction Strategies

    6 week and 3 month follow ups

  • Employment Outcomes

    6 week and 3 month follow ups

  • Satisfaction With Life

    6 week and 3 month follow ups

  • +1 more secondary outcomes

Study Arms (2)

Relaxation training (REL)

PLACEBO COMPARATOR

This was a 1-hr behavioral counseling session designed to control for nonspecific therapeutic effects by providing equivalent levels of attention from and rapport with a counselor. It began with an introduction and rapport building. The counselor asked about the participant's daily stress level and strategies used to cope. Experience with meditation and relaxation were explored. The counselor presented a rationale for the use of REL for alcohol reduction, namely: the transition to adulthood can be stressful, and stress can lead to increased alcohol use; meditation and relaxation can reduce stress and thereby prevent excessive alcohol use. Didactic information about mental and physical stress and coping was provided. Two strategies were practiced: a simple, guided breathing meditation and a full-body progressive muscle relaxation. The session concluded with a review of the participant's experiences during the 2 exercises and a recommendation to practice the techniques regularly.

Behavioral: Relaxation training

Brief Motivational Intervention (BMI)

ACTIVE COMPARATOR

This is a 1-hr motivational intervention session. The counselor built rapport while eliciting information about the participant's drinking, discussing current experiences, goals and plans in different domains (education, work, financial independence, social transitions, relationships). The counselor explored how drinking fit into the participant's life and explored risk and protective factors. The session involved: Assessing motivation; Enhancing motivation; Personalized feedback; Envisioning the future with/without change; Counselor summary; and Optional personalized change plan. Participant strengths, protective factors, and autonomy/ability to make changes were elicited and supported. Counselors used MI principles and techniques, including using open-ended questions, reflective listening, eliciting change talk, and supporting self-efficacy statements.

Behavioral: Brief Motivational Counseling

Interventions

One hour session of brief motivational counseling focused on reduction of heavy drinking.

Also known as: Brief Motivational Intervention, BMI
Brief Motivational Intervention (BMI)

One hour training in relaxation techniques

Also known as: REL
Relaxation training (REL)

Eligibility Criteria

Age17 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • high school students anticipating graduation within 3 months, drop outs or graduates
  • males must report at least one day drinking 5 or more standard drinks in past month
  • females must report at least one day drinking 4 or more standard drinks in past month

You may not qualify if:

  • plans to enroll at traditional 4-year college within 12 months
  • plans to enter military within next 12 months
  • plans to move more than 1 hour from current location in within 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Colby SM, Orchowski L, Magill M, Murphy JG, Brazil LA, Apodaca TR, Kahler CW, Barnett NP. Brief Motivational Intervention for Underage Young Adult Drinkers: Results from a Randomized Clinical Trial. Alcohol Clin Exp Res. 2018 Jul;42(7):1342-1351. doi: 10.1111/acer.13770. Epub 2018 Jun 6.

MeSH Terms

Conditions

Binge Drinking

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Suzanne Colby
Organization
Brown University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Research

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 7, 2012

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 12, 2025

Results First Posted

March 5, 2025

Record last verified: 2025-05