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

NCT04147455 | Completed Results

• 1 other identifier: IRB00099860
• Study Type: interventional
• Target: 793
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexual Violence

Keywords

Behavioral intervention; Violent behavior

Outcome Measures

Primary Outcomes (4)

• Number of Participants Reporting Contact Sexual Violence Via Physical Tactics

  Acts of contact sexual violence using physical tactics (force or threat of harm) were assessed using 7 items from the Sexual Experiences Survey. The 7 items are scored on a scale from 0 (zero acts) to 3 (multiple acts), indicating how many times the participant reported engaging in a specific tactic in order to engage in contact sexual violence, including unwanted touching, rape, and attempted rape. The numbers of participants indicating they used physical tactics at least once (scores of 1 or 2) to perpetrate any of seven acts of contact physical violence (in the past twelve months, for the baseline assessment, or since last completing the questionnaire) are presented here.

  Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

• Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics

  Acts of contact sexual violence using non-physical tactics (verbal coercion, lying, or intoxication) were assessed using 7 items from the Sexual Experiences Survey. The 7 items are scored on a scale from 0 (zero tactics) to 3 (multiple tactics), indicating how many times the participant reported engaging in a specific tactic in order to engage in contact sexual violence, including unwanted touching, rape, and attempted rape. The numbers of participants indicating they used non-physical tactics at least once (scores of 1 or 2) to perpetrate any of seven acts of contact physical violence (in the past twelve months, for the baseline assessment, or since last completing the questionnaire) are presented here.

  Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

• Number of Participants Reporting Non-contact Sexual Violence

  Acts of non-contact sexual violence were assessed using 10 items from the Sexual Experiences Survey. The 10 items are scored on a scale from 0 (zero acts) to 3 (multiple acts), indicating how many times the participant reported engaging in an act. The numbers of participants indicating they engaged in at least one act of non-contact sexually violent behavior (scores of 1 or 2) in the past twelve months, for the baseline assessment, or since last completing the questionnaire are presented here.

  Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

• Number of Participants Reporting Prosocial Bystander Behavior

  Participants were asked if they had engaged in any of four prosocial bystander behaviors in the past 12 months (or since the last time completing the questionnaire). Items are scored as 0 = never performed, 1 = performed once, 2 = performed more than once. The numbers of participants who report engaging in at least one of four prosocial bystander behaviors at least once are presented here.

  Six months following baseline

Secondary Outcomes (8)

• Knowledge of Legal Definitions of Assault and Rape Scale Score

  Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

• Knowledge of Informed Consent to Have Sex Score

  Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

• Gender Roles Score

  Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

• Myths and Realities About Sexual Violence Score

  Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention

• Sexual Coercion Score

  Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention

Study Arms (2)

RealConsent

EXPERIMENTAL

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

Behavioral: Adapted RealConsent

Health Education Control Condition

ACTIVE COMPARATOR

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

Behavioral: Health Education Control Condition

Interventions

Adapted RealConsent 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

RealConsent

Health Education Control Condition BEHAVIORAL

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

Health Education Control Condition

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead
• Center for Creative Initiatives in Health and Population: collaborator

Study Sites (2)

Thang Long University

Hanoi, 100000, Vietnam

Location

Hanoi Medical University

Hanoi, 116001, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 32873262 BACKGROUND

• 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.

  PMID: 36705965 DERIVED

Limitations and Caveats

The 12-month follow-up period allowed for a short-term impact assessment of the intervention. Longer-term follow-up of participants is needed to assess the impact of the intervention on behavioral outcomes throughout men's time at university, and beyond.

Results Point of Contact

• Title: Dr. Kathryn Yount
• Organization: Emory University

kyount@emory.edu

404-727-8511

Study Officials

• Kathryn Yount, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: September 11, 2019
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: October 8, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available for sharing beginning 12 months after the end of the study, with no end date.
• Access Criteria: Data are available for sharing with researchers requesting data from the Principal Investigator and study steam, providing the analysis plan and study aims are approved. Data will be shared via a secure link through Emory Box as STATA, Excel, and SAS files.

Locations

VN (2)