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

Sexual Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147455
• Other study ID #: IRB00099860
• Status: Completed
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: September 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Violence

Intervention

Behavioral:
• 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
• Health Education Control Condition
Participants will view six 30-minute web-based serial drama modules designed to promote health.

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University	Hanoi
Vietnam	Thang Long University	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Center for Creative Initiatives in Health and Population

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Knowledge of Legal Definitions of Assault and Rape Scale Score	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
Secondary	Knowledge of Informed Consent to Have Sex Score	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
Secondary	Gender Roles Score	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
Secondary	Myths and Realities About Sexual Violence Score	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
Secondary	Sexual Coercion Score	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
Secondary	Sexual Violence Myths Score	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
Secondary	Alcohol and Consent Score	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
Secondary	Rape Empathy Score	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