Preventing Sexual Violence in College Men: RealConsent for Use in Vietnam

NCT ID: NCT04147455

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 793 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2020-12-02

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.

Conditions

Sexual Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

RealConsent

Participants randomized to this study arm will receive an adapted program of RealConsent.

Group Type: EXPERIMENTAL

Adapted RealConsent

Intervention Type: BEHAVIORAL

The program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants will view six 30-minute modules designed to prevent sexual violence in young men

Health Education Control Condition

Participants in the control arm will receive a web-based health promotion program.

Group Type: ACTIVE_COMPARATOR

Health Education Control Condition

Intervention Type: BEHAVIORAL

Participants will view six 30-minute web-based serial drama modules designed to promote health.

Interventions

Adapted RealConsent

The program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants will view six 30-minute modules designed to prevent sexual violence in young men

Intervention Type: BEHAVIORAL

Health Education Control Condition

Participants will view six 30-minute web-based serial drama modules designed to promote health.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Center for Creative Initiatives in Health and Population

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Yount

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Yount, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Thang Long University

Hanoi, , Vietnam

Hanoi Medical University

Hanoi, , Vietnam

Countries

Vietnam

References

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.

Reference Type: BACKGROUND

PMID: 32873262 (View on PubMed)

Yount KM, Cheong YF, Bergenfeld I, Trang QT, Sales JM, Li Y, Minh TH. Impacts of GlobalConsent, a Web-Based Social Norms Edutainment Program, on Sexually Violent Behavior and Bystander Behavior Among University Men in Vietnam: Randomized Controlled Trial. JMIR Public Health Surveill. 2023 Jan 27;9:e35116. doi: 10.2196/35116.

Reference Type: DERIVED

PMID: 36705965 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00099860

Identifier Type: -

Identifier Source: org_study_id