NCT02834949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
393

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

5.1 years

First QC Date

July 8, 2016

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Alcohol Use from baseline to follow-up (4 timepoints)

    Self-reported drinks consumed in a typical week

    Baseline, 1-month, 6-months, 12-months and 16-months

  • Change in Alcohol-related Problems from baseline to follow-up (4 timepoints)

    Self-reported alcohol-related consequences

    Baseline, 1-month, 6-months, 12-months and 16-months

Study Arms (3)

BMI + SFAS

EXPERIMENTAL

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.

Behavioral: Brief Motivational Intervention (BMI)Behavioral: Substance-Free Activity Session (SFAS)

BMI + Relaxation Session

ACTIVE COMPARATOR

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.

Behavioral: Brief Motivational Intervention (BMI)Behavioral: Relaxation Session

Assessment

NO INTERVENTION

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

Interventions

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.

BMI + Relaxation SessionBMI + SFAS

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.

BMI + SFAS

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.

BMI + Relaxation Session

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Employed more than 20 hours per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Missouri

Columbia, Missouri, 65211, United States

Location

University of Memphis

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • James G Murphy, Ph.D.

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 15, 2016

Study Start

July 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

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.

Locations