Protective Behavioral Strategies and Brief Alcohol Interventions
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protective Behavioral Strategies
Personalized Normative Feedback
Alcohol Education
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Consumption
Eligibility Criteria
Inclusion Criteria:
- At least one binge drinking episode in the preceding month
Exclusion Criteria:
- At-risk for alcohol dependence or major depressive disorder
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Protective Behavioral Strategies
Personalized Normative Feedback
Alcohol Education
Arm Description
Personalized feedback on use of protective behavioral strategies.
Personalized feedback on how one's own drinking compares to relevant norms.
Educational information about harms associated with heavy drinking.
Outcomes
Primary Outcome Measures
Drinks Per Week
Rutgers Alcohol Problems Index (RAPI)
Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.
Secondary Outcome Measures
Drinking Norms Rating Form
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.
Protective Behavioral Strategies Scale.
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).
Full Information
NCT ID
NCT01168726
First Posted
July 20, 2010
Last Updated
June 15, 2017
Sponsor
University of Missouri-Columbia
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT01168726
Brief Title
Protective Behavioral Strategies and Brief Alcohol Interventions
Official Title
Protective Behavioral Strategies and Brief Alcohol Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
365 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protective Behavioral Strategies
Arm Type
Experimental
Arm Description
Personalized feedback on use of protective behavioral strategies.
Arm Title
Personalized Normative Feedback
Arm Type
Experimental
Arm Description
Personalized feedback on how one's own drinking compares to relevant norms.
Arm Title
Alcohol Education
Arm Type
Active Comparator
Arm Description
Educational information about harms associated with heavy drinking.
Intervention Type
Behavioral
Intervention Name(s)
Protective Behavioral Strategies
Intervention Description
Personalized feedback on use of protective behavioral strategies.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Normative Feedback
Intervention Description
Personalized feedback on how one's own drinking compares to relevant norms.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Education
Intervention Description
Educational information about harms associated with heavy drinking.
Primary Outcome Measure Information:
Title
Drinks Per Week
Time Frame
6 Months
Title
Rutgers Alcohol Problems Index (RAPI)
Description
Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Drinking Norms Rating Form
Description
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.
Time Frame
6 months
Title
Protective Behavioral Strategies Scale.
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one binge drinking episode in the preceding month
Exclusion Criteria:
At-risk for alcohol dependence or major depressive disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew P Martens, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Protective Behavioral Strategies and Brief Alcohol Interventions
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