NCT02603978

Brief Summary

The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander and social norms intervention are effective at reducing alcohol use and sexual-related behaviors among college men mandated to receive an alcohol intervention by their university.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Typical duration for phase_2

Status
unknown

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

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

November 6, 2015

Last Update Submit

September 18, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Alcohol Use Disorders Identification Test

    A self-report measure that examines alcohol use and problems. This measure produces one total score that is interpreted as "alcohol use and problems."

    6 months post-intervention

  • Bystander Behavior Scale

    A self-report measure that examines opportunities and engagement in prosocial bystander behavior. A single total score is obtained by calculating the percentage of times individuals engaged in bystander behavior based on the number of opportunities they had for such behavior.

    6 months post-intervention

Study Arms (4)

Wait-list

NO INTERVENTION

This arm will receive no intervention for the first 6 months. At the conclusion of the 6-month period, this group will receive a brief alcohol intervention

Brief Alcohol Intervention

ACTIVE COMPARATOR

This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing

Behavioral: BASICS

Bystander and Social Norms Intervention

ACTIVE COMPARATOR

This arm will receive a brief (2-hour) bystander and social norms intervention designed to increase healthy sexual behaviors

Behavioral: Bystander and Social Norms

Combined Alcohol and Bystander Intervention

ACTIVE COMPARATOR

This arm will receive a combined (4-hour) alcohol and bystander/social norms intervention to target both alcohol and sexual behavior

Behavioral: Combined BASICS and Bystander

Interventions

BASICSBEHAVIORAL

A 2-hour group intervention focused on reducing alcohol use with the use of motivational interviewing

Brief Alcohol Intervention

A 2-hour group intervention focused on increasing healthy sexual behaviors and prosocial bystander behavior

Bystander and Social Norms Intervention

A 2-session, 4-hour group that consists of both BASICS and the Bystander intervention

Combined Alcohol and Bystander Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 or older; must be an ohio university student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University

You may not qualify if:

  • Under the age of 18; not attending the main Ohio University campus (Athens)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 13, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

September 19, 2017

Record last verified: 2017-09