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Binge DrinkingNCT01546025

Brief Alcohol Intervention for School-to-Work Transitions

A study testing Brief Motivational Counseling and Relaxation training in people with Binge Drinking, run by Brown University.

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

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. Read more about this study

Who is it for?
Ages 17 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Binge Drinking
What is being tested?
Brief Motivational Counseling and Relaxation training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
No sites listed yet
Study dates
Jun 2010to Oct 2011
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 17 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the detailed description

This study tested the efficacy of a single session of BMI for reducing heavy drinking and related adverse consequences among underage young adult drinkers not attending a 4-year college or university. We designed the intervention to be delivered proximal to the transition out of high school (with or without graduation), because such periods of transition and discontinuity in the life course present opportunities to positively alter developmental paths (Masten et al., 2009). Thus, interventions timed to co-occur with naturalistic transition points may have great potential for decreasing drinking trajectories or preventing harmful escalations in trajectories going forward. To increase the applicability of our findings to the heterogeneous population of community-dwelling young adults, our recruitment targeted a purposefully inclusive "non-4-year-college" population. We hypothesized that, compared to a time and attention-matched control condition (i.e., relaxation training [REL]), BMI would result in significantly reduced heavy drinking and reduced adverse consequences of alcohol use at 6-week and 3-month follow-up.

Conditions
Binge Drinking
Being tested
Brief Motivational Counseling, Relaxation training
Medical subject headings
Binge Drinking

What participants receive

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

  • Brief Motivational CounselingBehavioural

    Also called Brief Motivational Intervention, BMI

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

  • Relaxation trainingBehavioural

    Also called REL

    One hour training in relaxation techniques

Study groups in NCT01546025
Study groupRoleWhat they receive
Relaxation training (REL)Placebo comparatorThis 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.
Receives: Behavioral: Relaxation training
Brief Motivational Intervention (BMI)Active comparatorThis 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.
Receives: Behavioral: Brief Motivational Counseling

What is being measured

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

  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

    Measured: 3 months

Secondary outcomes (6)

  1. Brief Young Adult Alcohol Consequences Questionnaire

    Measure of problem severity in young adult drinkers. Respondents indicated on the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Kahler et al., 2005) whether they had experienced each of 24 adverse alcohol-related consequences in the prior 6 weeks; items are summed for a total score (Cronbach's α = 0.81 at BL), with a minimum score of 0 and a maximum score of 24. Higher scores indicate worse outcome.

    Measured: 6 week and 3 month follow ups

  2. Help Seeking

    Count of participants reporting receiving any type of counseling for alcohol in the prior 6 weeks

    Measured: 6 week and 3 month follow ups

  3. Drinking Reduction Strategies

    Total score on the Strategies to Limit Drinking 31-item scale. Likert response for each item ranges from 1 = never to 5 = always; range = 31 to 155; higher scores indicate better outcomes: higher scores reflect greater frequency of using various strategies to deliberately limit one's drinking over the past 6 weeks

    Measured: 6 week and 3 month follow ups

  4. Employment Outcomes

    Mean score on the "Your Workplace" questionnaire: Negative Effects on Work Performance subscale.

    Range = 0 to 5. Response options for each item on the subscale are 0 = never; 1 = once or twice, 2 = about once every 2 weeks, 3 = about once a week, 4 = 2-4 times a week, 5 = about daily.

    Higher scores indicate worse outcomes: Higher scores reflect more frequent negative effects of alcohol use on work performance in the past 6 weeks.

    Measured: 6 week and 3 month follow ups

  5. Satisfaction With Life

    This is a mean score on the Satisfaction With Life Scale (SWLS), a 5-item instrument designed to measure global cognitive judgments of life satisfaction, using a 7-point Likert scale (1=strongly disagree to 7=strongly agree), with higher scores indicating better outcomes, i.e., higher scores indicate greater life satisfaction at the time of assessment. Range = 1 to 7.

    Measured: 6 week and 3 month follow ups

  6. Adolescent Reinforcement Survey Schedule (ARSS)

    The ARSS contains a list of 45 rewarding activities. Participants rate the frequency with which they participate in each activity WITH and then WITHOUT alcohol/drug use, and then rate their enjoyment of each activity WITH and WITHOUT alcohol/drug use. The outcome measure represents the percentage of reinforcement participants get (i.e., the cross product of frequency X enjoyment) from activities involving alcohol/drug use divided by the total reinforcement they get from all activities with or without alcohol/drug use. Range = 0 to 100; higher scores indicate worse outcomes, i.e., higher scores reflect a greater percentage of enjoyable activities involving alcohol and/or use.

    Measured: 6 week and 3 month follow ups

Timeline

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

  1. First posted7 Mar 2012 (estimated)
  2. Study startJun 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

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
Masking
Single blind
Who is masked
Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546025
Sponsor's protocol ID
R01AA016000
Other IDs
R01AA016000
Status last verified
May 2025
First submitted
20 Feb 2012
Last updated
12 Jun 2025

Publications

  • 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.

    PubMed 29750362

Questions about this trial

What is this clinical trial studying?

A study testing Brief Motivational Counseling and Relaxation training in people with Binge Drinking, run by Brown University.

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 3 inclusion and 3 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 12 Jun 2025. 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. Some participants in this study may receive a placebo. 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 5 Mar 2025). 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?

Timeline Follow Back Assessing Number of Standard Drinks (time frame: 3 months). 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 NCT01546025, 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 12 Jun 2025.

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Clinical Trial NCT01546025 | AzTrials