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

September 15, 2021 updated by: Kathryn Yount, Emory University

Preventing Sexual Violence in College Men: Adaptation and Impact Evaluation of RealConsent for Use in Vietnam

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

793

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

      • Hanoi, Vietnam, 100000
        • Thang Long University
      • Hanoi, Vietnam, 116001
        • Hanoi Medical University

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

No

Genders Eligible for Study

Male

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RealConsent
Participants randomized to this study arm will receive an adapted program of 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
ACTIVE_COMPARATOR: Health Education Control Condition
Participants in the control arm will receive a web-based health promotion program.
Participants will view six 30-minute web-based serial drama modules designed to promote health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
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
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
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
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
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
Time Frame: Six months following baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of Legal Definitions of Assault and Rape Scale Score
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Knowledge of the law is assessed with 22 items where respondents indicate if they think the situations described are illegal (scored as 1), legal, but harmful (2), or not sexual violence (3), with example items including "Forcing a person to have oral sex" and "Pressuring someone to have sex." Items were re-coded such that responses indicating an accurate estimate or overestimate of the illegality and harms of sexual violence were coded as "1" and items indicating an underestimation as of the illegality and harms of sexual violence were coded as "0". Total scores range from 0 to 22 with higher scores indicating greater awareness of laws and consequences related to sexual violence.
Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Knowledge of Informed Consent to Have Sex Score
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Knowledge of sexual consent is assessed with 15 items where respondents indicate how much they agree with each statement on a 5-point Likert scale of 1 to 5, where 1 = totally agree and 5 = totally disagree. This scale was adapted from fifteen items of the Sexual Consent Attitudes and Behaviors scale. Example items include "The need to ask for sexual consent DECREASES as the length of a dating relationship INCREASES" and "If your partner initiates sexual contact, it is okay to continue, even if she/he is drunk". Several items were reverse-coded to maintain common valence, and all response options were re-coded to range from 0-4. Total scores range from 0 to 60 where higher scores indicate greater knowledge about sexual consent.
Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Gender Roles Score
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
The Gender Role Attitudes (GRA) scale measures men's gender role attitudes. The fifteen-item scale was adapted from the Gender Equitable Men (GEM) scale, a scale that was adapted for use in Nepal from the GEM scale, the Male Role Norms Inventory (MRNI)-Adolescent-revised scale, the Gender Attitudes Scale, and the International Men and Gender Equality Survey (IMAGES). Example items included: "A woman should obey her husband even when she disagrees with him" and "Men should be the ones to initiate dating relationships". Response options were coded using a 5-point Likert scale ranging from totally agree (1) to totally disagree (5). Two items needed to be reverse coded to maintain common valence, and all items were re-coded to range from 0-4, resulting in a theoretical score range of 0-60, with higher scores indicating more equitable attitudes.
Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Myths and Realities About Sexual Violence Score
Time Frame: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Beliefs about what other men think about myths and realities of sexual violence was to be assessed with 24 items asking respondents to indicate how much they agree with each statement. Responses were to be given on a scale from 1 to 5 where 1 = totally agree and 5 = totally disagree. Total scores range from 24 to 120 with lower scores indicating that the respondent thinks men his age agree more with myths concerning sexual violence.
Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Sexual Coercion Score
Time Frame: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
This 19-item scale was adapted from the Sexual Coercion in Intimate Relationships scale. Examples of items in the scale included: "Saying that a person would have sex with you if they truly love you" and "Asking your dating partner repeatedly to perform a sexual act after they have said that they do not want to". Response options were coded into "No" (0), "Yes" (1) and "Unsure" (2). Three items had to be reverse coded to maintain common valence. For analysis, "No" and "Unsure" were re-coded into one response option. Scores range from 0-19. Higher scores indicate a greater understanding of behaviors that are sexually coercive.
Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Sexual Violence Myths Score
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Rape attitudes were assessed with 28 items presenting myths about rape. Items are scored on a 5-point Likert scale from 1 to 5 where 1 = totally agree and 5 = totally disagree. The Rape Myth Attitudes (RMA) scale measures the extent of men's endorsement (or non-endorsement) of common rape myths. This scale was adapted from fourteen items of the Illinois Rape Myth Scale-Short Form and eleven items of the College Date Rape Attitude and Behavior Survey. Example items included: "When guys rape, it is usually because of their strong desire for sex" and "In most cases when a woman was raped, she was asking for it". Several items were reverse-coded to maintain common valence, and all response options were re-coded 0-4, resulting in a theoretical range of 0-112, with higher scores indicating less endorsement of rape myths.
Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Alcohol and Consent Score
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Beliefs about consent in terms of alcohol use are assessed with 5 items adapted from the College Date Rape Attitudes and Behaviors scale where respondents indicate how much they agree with each statement. Responses are on a scale from 1 = totally agree to 5 = totally disagree. Items were re-coded to be grounded at zero. Total scores range from 0 to 20 where higher scores indicate more understanding of sexual consent under the influence of alcohol.
Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Rape Empathy Score
Time Frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Empathy for rape victims was assessed with a modified version of the Rape Empathy Scale (RES). This assessment includes 17 items where participants were asked to choose between two statements, one of which reflected greater empathy towards rapists ("I understand the helplessness a rapist might feel during a rape, since he cannot control his actions") and one of which reflected greater empathy towards victims ("I understand the helplessness a victim might feel during a rape"). Responses are scored as 1 (more empathy for victim) or 0 (more empathy for perpetrator) and total scores range from 0 to 17 where higher scores indicate more empathy towards rape victims.
Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (ACTUAL)

September 11, 2019

Primary Completion (ACTUAL)

December 2, 2020

Study Completion (ACTUAL)

December 2, 2020

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (ACTUAL)

November 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00099860

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified data will be available for sharing, including data dictionaries, with the exception of potentially sensitive items on sexual violence perpetration.

IPD Sharing Time Frame

Data will be made available for sharing beginning 12 months after the end of the study, with no end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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