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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Missouri
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protective Behavioral Strategies
Personalized feedback on use of protective behavioral strategies.
Behavioral: 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.
Behavioral: Personalized Normative Feedback
Personalized feedback on how one's own drinking compares to relevant norms.
Active Comparator: Alcohol Education
Educational information about harms associated with heavy drinking.
Behavioral: Alcohol Education
Educational information about harms associated with heavy drinking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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