- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903876
A Web-based Bystander Education Program (RealConsent)
July 22, 2014 updated by: Laura F Salazar, Emory University
Preventing Violence Against Women: A Web-based Approach
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
743
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Georgia State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: General Health promotion
A 3-hour general mental health web-based program.
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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.
Other Names:
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Experimental: Bystander & Sexual Violence Prevention
A 3-hour web-based program designed to teach male college student bystanders to intervene.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosocial Intervening Behavior
Time Frame: 6 months
|
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).
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Violence Perpetration
Time Frame: 6 months
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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).
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura F Salazar, PhD, Emory University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
July 17, 2013
First Posted (Estimate)
July 19, 2013
Study Record Updates
Last Update Posted (Estimate)
July 23, 2014
Last Update Submitted That Met QC Criteria
July 22, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- IRB00000472
- R49CE000892 (U.S. NIH Grant/Contract)
- EmoryVAW (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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