An interventional study of Brief Motivational Counseling and Relaxation training in Binge Drinking, sponsored by Brown University. Completed. Open to participants aged 17 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 168 is above the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
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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
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
One hour session of brief motivational counseling focused on reduction of heavy drinking.
Also known as: Brief Motivational Intervention, BMI
One hour training in relaxation techniques
Also known as: REL
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
Time frame: 3 months
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.
Time frame: 6 week and 3 month follow ups
Help Seeking
Count of participants reporting receiving any type of counseling for alcohol in the prior 6 weeks
Time frame: 6 week and 3 month follow ups
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
Time frame: 6 week and 3 month follow ups
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.
Time frame: 6 week and 3 month follow ups
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.
Time frame: 6 week and 3 month follow ups
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.
Time frame: 6 week and 3 month follow ups
The study was promoted via posted flyers in the community; advertisements on buses, websites, and in newspapers; and recruitment events at high schools, community colleges, vocational/technical programs, social service agencies, and GED classes. Research staff described the study to groups/classes or at information booths set up in a lobby or cafeteria. Data collection took place in Rhode Island and Southeastern Massachusetts from June 2010 to October 2011.
| Milestone | Relaxation Training | Brief Motivational Counseling |
|---|---|---|
| Started | 84 | 83 |
| Completed treatment | 84 | 83 |
| 6-week follow up | 82 | 80 |
| 3-month follow up | 81 | 80 |
| Completed | 84 | 82 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
This is a calculation of the number of standard alcohol drinks consumed per week, based on data collected via the timeline follow back interview
| standard drinks/week | Relaxation Training | Brief Motivational Counseling |
|---|---|---|
| Timeline Follow Back Assessing Number of Standard Drinks | 8.93 ± 10.00 | 5.56 ± 5.91 |
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.
| units on a scale | Relaxation Training | Brief Motivational Counseling |
|---|---|---|
| Brief Young Adult Alcohol Consequences Questionnaire 6 weeks | 6.43 ± 0.50 | 5.47 ± 0.49 |
| Brief Young Adult Alcohol Consequences Questionnaire 3 months | 6.01 ± 0.52 | 4.85 ± 0.51 |
Count of participants reporting receiving any type of counseling for alcohol in the prior 6 weeks
| Participants | Relaxation Training (REL) | Brief Motivational Intervention (BMI) |
|---|---|---|
| Number reporting alcohol counseling, 6 week follow up | 10 | 9 |
| Number reporting alcohol counseling, 3 month follow up | 6 | 8 |
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
| units on a scale | Relaxation Training (REL) | Brief Motivational Intervention (BMI) |
|---|---|---|
| Drinking reduction score, 6 week follow up | 94.6 ± 27.7 | 99.6 ± 27.4 |
| Drinking reduction score, 3 month follow up | 89.9 ± 29.8 | 98.6 ± 31.1 |
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.
| units on a scale | Relaxation Training (REL) | Brief Motivational Intervention (BMI) |
|---|---|---|
| Negative alcohol effects at work, 6 week follow up | 0.16 ± 0.44 | 0.13 ± 0.31 |
| Negative alcohol effects at work, 3 month follow up | 0.14 ± 0.51 | 0.12 ± 0.28 |
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.
| units on a scale | Relaxation Training (REL) | Brief Motivational Intervention (BMI) |
|---|---|---|
| General life satisfaction, 6 week follow up | 4.80 ± 1.43 | 4.72 ± 1.25 |
| General life satisfaction, 3 monnth follow up | 4.96 ± 1.41 | 4.95 ± 1.20 |
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.
| percentage of enjoyment due to alcohol | Relaxation Training (REL) | Brief Motivational Intervention (BMI) |
|---|---|---|
| Enjoyment attributed to alcohol, 6 week follow up | 33.7 ± 18.9 | 32.7 ± 19.3 |
| Enjoyment attributed to alcohol, 3 month follow up | 29.4 ± 21.0 | 30.0 ± 18.7 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relaxation Training | 0/84 (0%) | 0/84 (0%) | 0/84 (0%) |
| Brief Motivational Counseling | 0/83 (0%) | 0/83 (0%) | 0/83 (0%) |
| Age, Customized(Participants) | Relaxation Training | Brief Motivational Counseling | Total |
|---|---|---|---|
| age 17 | 22 | 24 | 46 |
| age 18 | 30 | 29 | 59 |
| age 19 | 24 | 19 | 43 |
| age 20 | 8 | 11 | 19 |
| Sex: Female, Male(Participants) | Relaxation Training | Brief Motivational Counseling | Total |
|---|---|---|---|
| Female | 36 | 34 | 70 |
| Male | 48 | 49 | 97 |
| Race/Ethnicity, Customized(Participants) | Relaxation Training | Brief Motivational Counseling | Total |
|---|---|---|---|
| Hispanic/Latino | 8 | 10 | 18 |
| Non-Hispanic White | 51 | 48 | 99 |
| Non-Hispanic Black/African American | 7 | 9 | 16 |
| American Indian/Native American | 0 | 1 | 1 |
| Asian/Pacific Islander | 6 | 1 | 7 |
| More than 1 race | 12 | 11 | 23 |
| missing | 0 | 3 | 3 |
| Avg Number of Standard Drinks per week(standard drinks per week) | Relaxation Training | Brief Motivational Counseling | Total |
|---|---|---|---|
| Mean | 12.14 ± 8.85 | 14.85 ± 14.41 | 13.49 ± 12.36 |
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