A Web-based Bystander Education Program

Sexual Violence Clinical Trial

— RealConsent  

Official title:

Preventing Violence Against Women: A Web-based Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903876
• Other study ID #: IRB00000472
• Secondary ID: R49CE000892Emory
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 22, 2014
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Student matriculated at Georgia State University

• Male

• 18 to 24

• Undergraduate

• Self-identify as heterosexual or bisexual

Exclusion Criteria:

• Graduate student

• Self-identify as homosexual

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexual Violence

Intervention

Behavioral:
• Bystander & Sexual Violence Prevention
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.
• General Health Promotion
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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sexual Violence Perpetration	This scale is the Conflict Tactics Scale revised, Sexual Coercion Subscale and assessed the number of sexually coercive/violent behaviors engaged in during the past 6 months. The index ranges from 0 (no engagement in any sexual violence) to 7 (engaged in all 7 sexually violent behaviors).	6 months	No