- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168726
Protective Behavioral Strategies and Brief Alcohol Interventions
June 15, 2017 updated by: Matthew P. Martens, University of Missouri-Columbia
Excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact.
The objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall public health benefit.
Subjects in the study will be randomized to one of two brief intervention conditions or an education-only control condition.
It is hypothesized that those in the intervention conditions will report greater reductions in alcohol use and alcohol-related problems than those in the control condition.
Study Overview
Status
Completed
Conditions
Detailed Description
The primary objective of this project is to examine factors that are associated with the effectiveness of intervention programs designed to reduce high-risk drinking among heavy drinking college students.
Previous research has found similar effect sizes for different types of multi-component, brief interventions among college students, but little research has assessed the degree to which specific components of such interventions are associated with intervention outcomes.
One common component of motivational enhancing interventions among college students involves providing cognitive-behavioral self-control strategies designed to reduce one's use of alcohol, which we term "protective behavioral strategies" (PBS).
However, there are two important factors that limit our understanding of the effects of PBS on client outcomes.
First, the use of these strategies in motivational enhancing programs has generally not been assessed in a systematic manner, due in part to the fact that until recently a standardized measure of such strategies did not exist.
Second, researchers have yet to conduct studies that dismantle the specific effects associated with the PBS component on client outcomes.
That is, studies have not tested interventions with and without assessment and feedback regarding a client's use of PBS.
Participants in this project will be "at-risk" college student drinkers who will be assigned to one of three conditions: a brief intervention that includes a focus on PBS, a brief intervention that does not include this focus, and an education-only control condition.
Participant will complete self-report measures of alcohol-related variables at baseline, 30-day, and 6-month follow-ups.
Mixed-model analyses will be used to determine the effectiveness of the intervention programs, and structural equation modeling will be used to determine if increases in PBS result in reductions in alcohol use/alcohol-related problems.
Study Type
Interventional
Enrollment (Actual)
365
Phase
- Not Applicable
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
-
-
Missouri
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Columbia, Missouri, United States, 65211
- University of Missouri
-
-
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 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least one binge drinking episode in the preceding month
Exclusion Criteria:
- At-risk for alcohol dependence or major depressive disorder
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protective Behavioral Strategies
Personalized feedback on use of protective behavioral strategies.
|
Personalized feedback on use of protective behavioral strategies.
|
|
Experimental: Personalized Normative Feedback
Personalized feedback on how one's own drinking compares to relevant norms.
|
Personalized feedback on how one's own drinking compares to relevant norms.
|
|
Active Comparator: Alcohol Education
Educational information about harms associated with heavy drinking.
|
Educational information about harms associated with heavy drinking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinks Per Week
Time Frame: 6 Months
|
6 Months
|
|
|
Rutgers Alcohol Problems Index (RAPI)
Time Frame: 6 months
|
Total scores on an alcohol problems scale.
Possible score range = 0-92.
Higher scores are indicative of more alcohol-related problems.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinking Norms Rating Form
Time Frame: 6 months
|
Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form.
Higher values indicate that the individual perceives higher levels of drinking among other students.
Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.
|
6 months
|
|
Protective Behavioral Strategies Scale.
Time Frame: 6 months
|
Use of protective behavioral strategies related to alcohol use.
Higher scores indicate more use of the strategies.
A total score was calculated by summing the three subscale scores on the measure (range = 3-18).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthew P Martens, PhD, University of Missouri-Columbia
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
January 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
July 20, 2010
First Submitted That Met QC Criteria
July 21, 2010
First Posted (Estimate)
July 23, 2010
Study Record Updates
Last Update Posted (Actual)
July 13, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protective Behaviors
- 1R21AA016779-01A2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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