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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01546025
Other study ID # R01AA016000
Secondary ID R01AA016000
Status Completed
Phase N/A
First received February 20, 2012
Last updated March 2, 2012
Start date June 2010
Est. completion date October 2011

Study information

Verified date March 2012
Source Brown University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 17 Years to 20 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Motivational Counseling
One hour session of brief motivational counseling focused on reduction of heavy drinking.
Relaxation training
One hour training in relaxation techniques

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome

Type Measure Description Time frame Safety issue
Primary Timeline Follow Back assessing number of standard drinks This assessment is used to measure average number of drinks per week, frequency of drinking, frequency of binge drinking, average BAC and peak BAC. 3 months No
Secondary Brief Young Adult Alcohol Consequences Questionnaire Measure of problem severity in young adult drinkers. 6 week and 3 month follow ups Yes
Secondary Help Seeking 6 week and 3 month follow ups No
Secondary Drinking Reduction Strategies 6 week and 3 month follow ups No
Secondary Employment Outcomes 6 week and 3 month follow ups No
Secondary Life Satisfaction 6 week and 3 month follow ups No
Secondary Adolescent Reinforcement Survey 6 week and 3 month follow ups No
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