NCT01903876

Brief Summary

This is a study to determine whether a theoretically-driven web-based 3-hour intervention designed for male college students called RealConsent is effective in increasing prosocial intervening behaviors and in preventing sexual violence perpetration. Sexual violence programs for this population have been implemented for decades in the United States, but a program that is web-based and incorporates the bystander education model has never been implemented or tested. In this study, male college students will be recruited online, enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the intervention, investigators will ask questions about their intervening and sexually coercive behaviors and other theoretical and empirical factors related to the study outcomes. Investigators will survey the young men again at post-intervention, and at 6-months follow-up to determine whether young men in the RealConsent program intervened more often and engaged in less sexual violence compared to young men in the comparison condition. The main hypotheses are: (1) college men in the RealConsent program will report more instances of prosocial intervening; and (2) college men in the RealConsent program will report less sexual violence against women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 23, 2014

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

July 17, 2013

Results QC Date

April 29, 2014

Last Update Submit

July 22, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prosocial Intervening Behavior

    This scale is the Reactions to Offensive Language and Behavior (ROLB) index that measures whether or not men confronted inappropriate behaviors of other men. We used the 7-item self-behavior subscale plus an additional 8 items, which directly reflected the content of RealConsent. A series of 15 potential intervening situations were presented and participants were asked to indicate whether they had experienced this situation in past 6 months (yes/no), and whether they had intervened (yes/no). The scale ranged from 0% (did not intervene anytime) to 100% (intervened every time).

    6 months

Secondary Outcomes (1)

  • Sexual Violence Perpetration

    6 months

Study Arms (2)

General Health promotion

PLACEBO COMPARATOR

A 3-hour general mental health web-based program.

Behavioral: General Health Promotion

Bystander & Sexual Violence Prevention

EXPERIMENTAL

A 3-hour web-based program designed to teach male college student bystanders to intervene.

Behavioral: Bystander & Sexual Violence Prevention

Interventions

This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place.

Also known as: RealConsent
Bystander & Sexual Violence Prevention

This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise.

Also known as: Stress & Mood Management
General Health promotion

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Student matriculated at Georgia State University
  • Male
  • to 24
  • Undergraduate
  • Self-identify as heterosexual or bisexual

You may not qualify if:

  • Graduate student
  • Self-identify as homosexual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

  • Salazar LF, Vivolo-Kantor A, Hardin J, Berkowitz A. A web-based sexual violence bystander intervention for male college students: randomized controlled trial. J Med Internet Res. 2014 Sep 5;16(9):e203. doi: 10.2196/jmir.3426.

Results Point of Contact

Title
Dr. Laura Salazar
Organization
Georgia State University

Study Officials

  • Laura F Salazar, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 19, 2013

Study Start

February 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 23, 2014

Results First Posted

July 23, 2014

Record last verified: 2014-07

Locations