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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00247182
Other study ID # NIAAABOR015518
Secondary ID NIH Grant R01 AA
Status Completed
Phase Phase 1
First received October 28, 2005
Last updated September 20, 2016
Start date October 2006
Est. completion date June 2011

Study information

Verified date September 2016
Source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This project provides stepped care to college students mandated for alcohol-related offenses. Students are first provided with a minimal intervention, a 15-minute discussion of their alcohol use. Students who continue to drink in a risky manner are provided with a more intensive, hour-long brief motivational interview. By providing more intensive treatment to the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol programs.


Description:

Colleges and universities have seen a large increase in the number of students referred to the administration for the violation of alcohol policies. However, research indicates that the majority of mandated students may not require extensive treatment. Stepped care assigns individuals to different levels of care according to their response to treatment. Encouraging research indicates that minimal interventions and BMIs may reduce heavy drinking in mandated college students. Thus, implementing stepped care using these interventions could maximize treatment efficiency and reduce the demands on campus alcohol programs.

Participants will be students mandated to attend an alcohol program at a northeastern private university. All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later, and those continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments. The three groups will be compared on two outcome measures: frequency of binge drinking episodes and alcohol-related problems in the past 30 days. Predictors of treatment response (readiness to change, alcohol expectancies, age of first drink, sensation seeking, descriptive norms, and reaction to the referral) will also be evaluated for both steps of the intervention. Research findings will assist college alcohol programs in determining the most effective and efficient allocation of their limited resources in treating mandated students. The long-term objectives of this research are to inform preventive intervention research about the utility and cost-effectiveness of stepped-care approaches and to identify individual and situational factors that qualify these effects.


Recruitment information / eligibility

Status Completed
Enrollment 598
Est. completion date June 2011
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male and female students 18 years of age or older.

- Participants will have signed a witnessed informed consent.

- Participants will have been referred for an alcohol-related offense

Exclusion Criteria:

- Participants who meet current DSM-IV criteria for substance use disorder

- Participants who are currently in treatment for substance use.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Step 1: Minimal Intervention
All participants will receive Step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. Participants will be assessed six weeks later. All students will complete 3, 6, and 9 month follow-up assessments
Step 2: Brief Motivational Intervention
Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.
Alcohol Assessment
Participants continuing to exhibit risky alcohol use will receive Step 2, randomization to: (a) a 60-90 minute brief motivational intervention (BMI) or (b) an assessment-only control. All students will complete 3, 6, and 9 month follow-up assessments.

Locations

Country Name City State
United States Roger Williams University Bristol Rhode Island

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (13)

Barnett NP, Borsari B, Hustad JT, Tevyaw TO, Colby SM, Kahler CW, Monti PM. Profiles of college students mandated to alcohol intervention. J Stud Alcohol Drugs. 2008 Sep;69(5):684-94. — View Citation

Barthelmes CK, Borsari B, Hustad JT, Barnett NP. Hostility in mandated students: exploratory analysis and implications for treatment. J Subst Abuse Treat. 2010 Apr;38(3):284-91. doi: 10.1016/j.jsat.2010.01.004. Epub 2010 Feb 8. — View Citation

Borsari B, Boyle KE, Hustad JT, Barnett NP, O'Leary Tevyaw T, Kahler CW. Drinking before drinking: pregaming and drinking games in mandated students. Addict Behav. 2007 Nov;32(11):2694-705. Epub 2007 May 17. — View Citation

Borsari B, Hustad JT, Mastroleo NR, Tevyaw TO, Barnett NP, Kahler CW, Short EE, Monti PM. Addressing alcohol use and problems in mandated college students: a randomized clinical trial using stepped care. J Consult Clin Psychol. 2012 Dec;80(6):1062-74. doi — View Citation

Borsari B, Magill M, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Eaton E, Monti PM. Mandated college students' response to sequentially administered alcohol interventions in a randomized clinical trial using stepped care. J Consult Clin Psy — View Citation

Borsari B, Muellerleile P. Collateral reports in the college setting: a meta-analytic integration. Alcohol Clin Exp Res. 2009 May;33(5):826-38. doi: 10.1111/j.1530-0277.2009.00902.x. Epub 2009 Mar 6. — View Citation

Borsari B, Murphy JG, Barnett NP. Predictors of alcohol use during the first year of college: implications for prevention. Addict Behav. 2007 Oct;32(10):2062-86. Epub 2007 Jan 23. — View Citation

Borsari B, O'Leary Tevyaw T, Barnett NP, Kahler CW, Monti PM. Stepped care for mandated college students: a pilot study. Am J Addict. 2007 Mar-Apr;16(2):131-7. — View Citation

Borsari B, Short EE, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Monti PM. Phone-delivered brief motivational interventions for mandated college students delivered during the summer months. J Subst Abuse Treat. 2014 May-Jun;46(5):592-6. doi — View Citation

Hustad JT, Eaton Short E, Borsari B, Barnett NP, O'Leary Tevyaw T, Kahler CW. College alcohol citations result in modest reductions in student drinking. J Subst Abuse Treat. 2011 Apr;40(3):281-6. doi: 10.1016/j.jsat.2010.11.005. Epub 2010 Dec 28. — View Citation

Kahler CW, Hustad J, Barnett NP, Strong DR, Borsari B. Validation of the 30-day version of the Brief Young Adult Alcohol Consequences Questionnaire for use in longitudinal studies. J Stud Alcohol Drugs. 2008 Jul;69(4):611-5. — View Citation

Teeters JB, Borsari B, Martens MP, Murphy JG. Brief Motivational Interventions Are Associated With Reductions in Alcohol-Impaired Driving Among College Drinkers. J Stud Alcohol Drugs. 2015 Sep;76(5):700-9. — View Citation

Yurasek AM, Borsari B, Magill M, Mastroleo NR, Hustad JT, Tevyaw TO, Barnett NP, Kahler CW, Monti PM. Descriptive norms and expectancies as mediators of a brief motivational intervention for mandated college students receiving stepped care for alcohol use — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol consumption 3, 6, and 9 months No
Primary Alcohol-related consequences 3, 6, and 9 months No
Secondary Predictors of response to treatment 3, 6, and 9 months No
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