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Improving Brief Alcohol Interventions With a Behavioral Economic Supplement

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Intervention (BMI)
Substance-Free Activity Session (SFAS)
Relaxation Session
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - 27 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female University of Memphis and University of Missouri
  • College freshman or sophomore
  • Full time student status
  • Report 2 or more heavy drinking episodes (5/4 drinks for men/women) in the past month

Exclusion Criteria:

  • Employed more than 20 hours per week

Sites / Locations

  • University of Missouri
  • University of Memphis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

BMI + SFAS

BMI + Relaxation Session

Assessment

Arm Description

Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities. The SFAS will be described to participants as the "College Adjustment Session" and the session will be conducted using an MI plus personalized feedback approach.

Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive a relaxation training session. In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, participants will be asked about their reaction to the relaxation techniques and provided with relaxation training handouts.

Participants will fill out a battery of measures and receive no intervention.

Outcomes

Primary Outcome Measures

Change in Alcohol Use from baseline to follow-up (4 timepoints)
Self-reported drinks consumed in a typical week
Change in Alcohol-related Problems from baseline to follow-up (4 timepoints)
Self-reported alcohol-related consequences

Secondary Outcome Measures

Full Information

First Posted
July 8, 2016
Last Updated
October 24, 2017
Sponsor
University of Memphis
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1. Study Identification

Unique Protocol Identification Number
NCT02834949
Brief Title
Improving Brief Alcohol Interventions With a Behavioral Economic Supplement
Official Title
Improving Brief Alcohol Interventions With a Behavioral Economic Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing alcohol use and alcohol-related consequences in college students.
Detailed Description
BMIs are associated with reductions in alcohol consumption and related problems, but effect sizes are generally small. One BMI trial indicated that behavioral economic variables such as low levels of proportionate substance-free reinforcement and inelastic demand for alcohol predicted poor intervention response, and that participants who successfully reduced their drinking increased their participation in academic and other substance-free activities. A subsequent NIAAA R21 developed a substance-free activity session (SFAS) supplement to traditional alcohol BMIs that attempted to increase engagement in constructive alternatives to drinking by enhancing the salience of delayed rewards (academic and career success) and the patterns of behavior (academic engagement) leading to these outcomes. This study indicated that a two session (alcohol BMI + SFAS) preventive intervention resulted in significantly greater reductions in alcohol problems relative to a two session (alcohol BMI + Relaxation) active control condition. The BMI+ SFAS was also associated with significantly greater reductions in heavy drinking for participants with lower levels of substance-free reinforcement at baseline. This was the first controlled study to demonstrate that a supplement to traditional BMIs can improve outcomes. The current study will extend these promising pilot results by (a) increasing the efficacy of the behavioral economic SFAS by including booster contact, (b) increasing power and generalizability by recruiting 425 students from two universities and including a no-treatment control group, (c) measuring drinking, as well as behavioral economic mechanisms as mediators and moderators of intervention outcomes (delay discounting, alcohol reinforcing efficacy, substance-free reinforcement) at 5 time points over a sixteen month period, and (d) evaluating the economic costs and benefits associated with the SFAS. The goals of the SFAS - increasing student engagement in academic, campus, and career-related activities- are consistent with the priorities of most colleges.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMI + SFAS
Arm Type
Experimental
Arm Description
Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities. The SFAS will be described to participants as the "College Adjustment Session" and the session will be conducted using an MI plus personalized feedback approach.
Arm Title
BMI + Relaxation Session
Arm Type
Active Comparator
Arm Description
Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive a relaxation training session. In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, participants will be asked about their reaction to the relaxation techniques and provided with relaxation training handouts.
Arm Title
Assessment
Arm Type
No Intervention
Arm Description
Participants will fill out a battery of measures and receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention (BMI)
Intervention Description
This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the student's perception of how much college students drink and actual student norms, (b) a comparison of the student's alcohol consumption vs. norms, (c) an estimate of the student's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.
Intervention Type
Behavioral
Intervention Name(s)
Substance-Free Activity Session (SFAS)
Intervention Description
The clinician initiates a discussion of the student's college and career goals. Students discuss the values that motivate them as well as how alcohol use may interfere with their ability to accomplish these goals. Students then receive information on graduation rates and income benefits for those who attend and excel in college. They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Session
Intervention Description
The session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, participants will be asked about their reaction to the relaxation techniques and provided with relaxation training handouts.
Primary Outcome Measure Information:
Title
Change in Alcohol Use from baseline to follow-up (4 timepoints)
Description
Self-reported drinks consumed in a typical week
Time Frame
Baseline, 1-month, 6-months, 12-months and 16-months
Title
Change in Alcohol-related Problems from baseline to follow-up (4 timepoints)
Description
Self-reported alcohol-related consequences
Time Frame
Baseline, 1-month, 6-months, 12-months and 16-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female University of Memphis and University of Missouri College freshman or sophomore Full time student status Report 2 or more heavy drinking episodes (5/4 drinks for men/women) in the past month Exclusion Criteria: Employed more than 20 hours per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Murphy, Ph.D.
Organizational Affiliation
University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
University of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will maintain a de-identified database and after they publish the primary outcomes, they will make an individual level data available to researchers who are conducting integrated analyses.

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Improving Brief Alcohol Interventions With a Behavioral Economic Supplement

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