Interventions for Sanctioned Ohio University Students

Examining the Efficacy of Interventions for Sexual Assault: A Preliminary Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: BASICS; Behavioral: Bystander and Social Norms; Behavioral: Combined BASICS and Bystander

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait-list; 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
Active Comparator: Brief Alcohol Intervention; This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing	Behavioral: BASICS; A 2-hour group intervention focused on reducing alcohol use with the use of motivational interviewing
Active Comparator: Bystander and Social Norms Intervention; This arm will receive a brief (2-hour) bystander and social norms intervention designed to increase healthy sexual behaviors	Behavioral: Bystander and Social Norms; A 2-hour group intervention focused on increasing healthy sexual behaviors and prosocial bystander behavior
Active Comparator: Combined Alcohol and Bystander Intervention; 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; A 2-session, 4-hour group that consists of both BASICS and the Bystander intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: American Psychological Foundation

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 15F018