NCT02983864

Brief Summary

The objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

December 1, 2016

Last Update Submit

March 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexual Experiences Survey

    A self-report measure that examines potential sexual assault behaviors

    6 months post-intervention

Secondary Outcomes (5)

  • Bystander Behavior Scale

    6 months post-intervention

  • Illinois Rape Myth Acceptance Scale

    6 months post-intervention

  • Sexual Social Norms Inventory

    6 months post-intervention

  • Alcohol use Disorders Identification Test

    6 months post-intervention

  • Comprehensive Effects of Alcohol

    6 months post-intervention

Study Arms (2)

Alcohol and Relaxation

ACTIVE COMPARATOR

This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing termed BASICS and a brief (1.5 hour) relaxation intervention

Behavioral: BASICSBehavioral: Relaxation

Alcohol and Relationships

ACTIVE COMPARATOR

This arm will receive a brief (4-hour), two session, integrated alcohol and relationship intervention based on motivational interviewing designed to increase healthy alcohol use and sexual behavior. The interventions are based on an integrated BASICS and integrated Bystander protocols

Behavioral: Integrated BASICSBehavioral: Integrated Bystander

Interventions

BASICSBEHAVIORAL

A one session intervention focused on reducing drinking with motivational interviewing

Alcohol and Relaxation

A one session intervention focused on reducing drinking and sexual behavior while drinking

Alcohol and Relationships
RelaxationBEHAVIORAL

A one session intervention focused on increasing relaxation skills

Alcohol and Relaxation

A one session intervention focused on reducing sexual assault with a focus on the role of alcohol

Alcohol and Relationships

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcohol DrinkingSexual Behavior

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Brian T Wymbs, PhD

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 6, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share