Clinical trial NCT04147455: Preventing Sexual Violence in College Men: RealConsent for Use in Vietnam
Official title: Preventing Sexual Violence in College Men: Adaptation and Impact Evaluation of RealConsent for Use in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Violence
Keywords: Behavioral intervention
Violent behavior
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Center for Creative Initiatives in Health and Population
First posted: 2019-11-01
Enrollment: 793
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial using a web-based adaptation of the RealConsent program among eligible college men in Hanoi, Vietnam. This study will test the impact of the program on promoting prosocial bystander behavior and preventing sexual violence perpetration, through improvements in the seven knowledge, attitudinal, and emotional mediators over a seven month study period, with a baseline survey and two follow-up surveys.

Detailed description: Sexual violence is any sexual act committed against a person without freely given consent. Men and women may experience sexual violence, but most victims are women. Women's first experiences of sexual violence often occur in adolescence. In Asia and the Pacific, about 14% of sexually experienced adolescent girls report forced sexual debut. Thus, early prevention with men is critical; yet, young men often are difficult to reach and may resist programs that target sexual violence, not seeing themselves as potential perpetrators. Prevention with men that integrates a bystander framework, which treats men as "allies" of women, is one way to target attitudes and behaviors while decreasing resistance to participation. In this study, the researchers will adapt an existing program for use with men attending one of two universities in Hanoi, Vietnam. This study will test the impact of the adapted program on knowledge/attitudinal/emotional mediators, and in turn, on sexual violence perpetration and prosocial bystander behavior in this target group. The adapted program is a novel, six-session, web-based serial drama and educational program designed to prevent sexual violence perpetration and to enhance prosocial bystander behavior in young men. The program has reduced the incidence of sexual violence among men attending an urban, public university in the Southeastern United States.

After conducting interviews with men and women, and focus group discussions with college men and university stakeholders the researchers will produce a web-based adaptation of the RealConsent program in Vietnam. The researchers will then conduct a randomized controlled trial to test the impact of the adapted program, relative to a health-education control condition, on knowledge/attitudinal/emotional mediators, and in turn, on sexually violent behaviors, and prosocial bystander behavior in freshmen men attending two universities in Hanoi. This project will be the first to adapt and to test the impact of a novel, theoretically grounded, web-based intervention to prevent sexual violence perpetration and to promote prosocial bystander behavior among young men for use in a middle-income country. If this study shows that the adapted program is effective cross-culturally, it will have exceptional potential for scale-up to prevent men's perpetration of sexual violence against women globally.

Eligibility criteria: Inclusion Criteria:

* Identifying as heterosexual or bisexual
* Enrolled as a freshman at Hanoi Medical University or Thang Long University on 9/1/2019

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Reporting Contact Sexual Violence Via Physical Tactics
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Number of Participants Reporting Non-contact Sexual Violence
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Number of Participants Reporting Prosocial Bystander Behavior
timeFrame: Six months following baseline
Secondary outcomes:
measure: Knowledge of Legal Definitions of Assault and Rape Scale Score
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Knowledge of Informed Consent to Have Sex Score
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Gender Roles Score
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Myths and Realities About Sexual Violence Score
timeFrame: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
measure: Sexual Coercion Score
timeFrame: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
measure: Sexual Violence Myths Score
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Alcohol and Consent Score
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
measure: Rape Empathy Score
timeFrame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Thang Long University
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
affiliation: Emory University
name: Kathryn Yount, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yount KM, Minh TH, Trang QT, Cheong YF, Bergenfeld I, Sales JM. Preventing sexual violence in college men: a randomized-controlled trial of GlobalConsent. BMC Public Health. 2020 Sep 1;20(1):1331. doi: 10.1186/s12889-020-09454-2.