Sexual ViolenceRealConsentNCT01903876
A Web-based Bystander Education Program
A study testing Bystander & Sexual Violence Prevention and General Health Promotion in people with Sexual Violence, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Bystander & Sexual Violence Prevention and General Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 743 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student matriculated at Georgia State University
- Male
- 18 to 24
- Undergraduate
- Self-identify as heterosexual or bisexual
Who cannot join
- Graduate student
- Self-identify as homosexual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sexual Violence
- Being tested
- Bystander & Sexual Violence Prevention, General Health Promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bystander & Sexual Violence PreventionBehavioural
Also called RealConsent
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 PromotionBehavioural
Also called Stress & Mood Management
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.
| Study group | Role | What they receive |
|---|---|---|
| General Health promotion | Placebo comparator | A 3-hour general mental health web-based program. Receives: Behavioral: General Health Promotion |
| Bystander & Sexual Violence Prevention | Experimental | A 3-hour web-based program designed to teach male college student bystanders to intervene. Receives: Behavioral: Bystander & Sexual Violence Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Laura F Salazar, Emory University
- Investigators
- Laura F Salazar, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903876
- Sponsor's protocol ID
- IRB00000472
- Other IDs
- R49CE000892, EmoryVAW
- Acronym
- RealConsent
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2013
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25198417
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Violence Against Women: A Web-based Approach
- ClinicalTrials.gov ID
- NCT01903876
- Acronym / sponsor ID
- RealConsent / IRB00000472
- Conditions
- Sexual Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 23 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Health promotion | Placebo comparator | Behavioral: General Health PromotionA 3-hour general mental health web-based program. |
| Bystander & Sexual Violence Prevention | Experimental | Behavioral: Bystander & Sexual Violence PreventionA 3-hour web-based program designed to teach male college student bystanders to intervene. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Student matriculated at Georgia State University
- Male
- 18 to 24
- Undergraduate
- Self-identify as heterosexual or bisexual
Key exclusion criteria (2 listed)
- Graduate student
- Self-identify as homosexual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bystander & Sexual Violence PreventionAlso: RealConsentThis 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. | Behavioural | Bystander & Sexual Violence Prevention |
| General Health PromotionAlso: Stress & Mood ManagementThis 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. | Behavioural | General Health promotion |
Primary outcome
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).
1 secondary outcome
Sexual Violence Perpetration
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25198417Salazar 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.
Related trials for Sexual Violence
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Enrolling by invitation
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
Acute Stress Symptoms, Sexual Violence
Recruiting
Centering Gender Affirming Resources in Higher Education
Sexual Violence, Drinking Heavy
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Not yet recruiting
Lakota Family Acceptance Project Pilot RCT
LGBTQ, Racial Disparities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura F Salazar, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bystander & Sexual Violence Prevention and General Health Promotion in people with Sexual Violence, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosocial Intervening Behavior (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01903876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.