Substance Use Risk Education (SURE) Project

Alcohol Drinking Clinical Trial

Official title:

Brief Alcohol Interventions by Counselor vs Computer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289965
• Other study ID #: NIAAACAR012518-06
• Secondary ID: R01AA012518NIH G
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2006
• Last updated: July 25, 2011
• Start date: September 2005
• Est. completion date: June 2009

Study information

• Verified date: July 2011
• Source: Syracuse University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This project is designed to compare college drinking interventions on outcomes and cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. We will also explore which participants might respond better to one intervention vs the others.

Description:

Many college students engage in heavy episodic drinking, a pattern that increases risks of undesired academic, social, health, and legal consequences. Fortunately, brief motivational interventions - when administered during face-to-face sessions by a trained counselor - can help students to reduce their heavy drinking and related consequences. However, use of such counselor-administered interventions on college campuses remains infrequent; instead, administrators rely on computerized brief interventions because they can be administered with fewer staff at lower cost. Two computer-administered interventions (AlcoholEdu and Alcohol 101 Plus) are used by more than 1,000 colleges and universities nationwide, even though these interventions have not been evaluated in controlled studies. Despite the magnitude of the college-drinking problem, no data have addressed the differential efficacy (or cost-effectiveness) of the computer-administered versus counselor-administered brief motivational interventions. Thus, the primary purpose of the proposed research is to address gaps in the scientific literature by evaluating outcomes of three types of brief motivational interventions: a theoretically-based and empirically-tested counselor-administered intervention and the two most popular computerized interventions. A secondary purpose of the proposed research is to identify predictors of outcomes, and moderators associated with differential intervention response. A tertiary purpose is to assess the cost-effectiveness of three types of brief motivational interventions. The proposed research will be a randomized controlled trial with four treatment conditions and four assessment occasions. We will recruit at-risk student drinkers who have been sanctioned to receive an alcohol education intervention because they violated a residence hall policy. These referred students will be randomized to one of the three interventions, or to a delayed intervention control; and assessed at baseline and again 1, 6, and 12 months later on key drinking and drinking consequences outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Freshman, sophomore, and junior college students

• Students sanctioned for an alcohol-related violation on campus

Exclusion Criteria:

• Year in college: senior

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking

Intervention

Behavioral:
• Counselor-administered Brief Motivational Intervention (BMI)
Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
• Alcohol 101 Plus (interactive CD-ROM)
Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.
• AlcoholEdu (Internet-based tutorial)
Students participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems.

Locations

Country	Name	City	State
United States	Syracuse University	Syracuse	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean number of drinks per week		12 months	No
Primary	drinks per drinking day		12 months	No
Primary	frequency of heavy drinking episodes		12 months	No
Primary	peak blood alcohol concentration (BAC)		12 months	No
Primary	Rutgers Alcohol Problems Index (RAPI) score		12 months	No
Secondary	readiness to change		12 months	No
Secondary	decisional balance		12 months	No
Secondary	client satisfaction		12 months	No
Secondary	norms perception		12 months	No

External Links

•   College Drinking: Changing the Culture - includes research, statistics, approaches to prevention, and interactive tools for students and educators.