Protective Behavioral Strategies and Brief Alcohol Interventions

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Matthew P. Martens, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01168726
First received: July 20, 2010
Last updated: June 9, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Alcohol Consumption
Behavioral: Protective Behavioral Strategies Feedback
Behavioral: Personalized Normative Feedback
Behavioral: Alcohol Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Protective Behavioral Strategies and Brief Alcohol Interventions

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Drinks Per Week [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Rutgers Alcohol Problems Index (RAPI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 365
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protective Behavioral Strategies Behavioral: Protective Behavioral Strategies Feedback
Personalized feedback on use of protective behavioral strategies.
Experimental: Personalized Normative Feedback Behavioral: Personalized Normative Feedback
Personalized feedback on how one's own drinking compares to relevant norms.
Active Comparator: Alcohol Education Behavioral: Alcohol Education
Educational information about harms associated with heavy drinking.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one binge drinking episode in the preceding month

Exclusion Criteria:

  • At-risk for alcohol dependence or major depressive disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168726

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Responsible Party: Matthew P. Martens, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01168726     History of Changes
Other Study ID Numbers: Protective Behaviors  1R21AA016779-01A2 
Study First Received: July 20, 2010
Results First Received: May 26, 2015
Last Updated: June 9, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016