- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00289965
Substance Use Risk Education (SURE) Project
July 25, 2011 updated by: Syracuse University
Brief Alcohol Interventions by Counselor vs Computer
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
703
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13244
- Syracuse University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Freshman, sophomore, and junior college students
- Students sanctioned for an alcohol-related violation on campus
Exclusion Criteria:
- Year in college: senior
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
in-person brief motivational intervention
|
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.
|
|
Active Comparator: 2
Alcohol 101plus
|
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.
|
|
Active Comparator: 3
AlcoholEdu (a Web-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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
mean number of drinks per week
Time Frame: 12 months
|
12 months
|
|
drinks per drinking day
Time Frame: 12 months
|
12 months
|
|
frequency of heavy drinking episodes
Time Frame: 12 months
|
12 months
|
|
peak blood alcohol concentration (BAC)
Time Frame: 12 months
|
12 months
|
|
Rutgers Alcohol Problems Index (RAPI) score
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
readiness to change
Time Frame: 12 months
|
12 months
|
|
decisional balance
Time Frame: 12 months
|
12 months
|
|
client satisfaction
Time Frame: 12 months
|
12 months
|
|
norms perception
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kate B. Carey, PhD, Syracuse University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
February 8, 2006
First Submitted That Met QC Criteria
February 8, 2006
First Posted (Estimate)
February 10, 2006
Study Record Updates
Last Update Posted (Estimate)
July 26, 2011
Last Update Submitted That Met QC Criteria
July 25, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAACAR012518-06
- R01AA012518 (U.S. NIH Grant/Contract)
- NIH Grant 2R01AA012518-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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