Trial Outcomes & Findings for Preventing Sexual Violence in College Men: RealConsent for Use in Vietnam (NCT NCT04147455)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

793 participants

Primary outcome timeframe

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

Results posted on

2021-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Health Education Control Condition Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Overall Study STARTED	397	396
Overall Study COMPLETED	375	364
Overall Study NOT COMPLETED	22	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.	Total n=793 Participants Total of all reporting groups
Age, Continuous	18.06 years STANDARD_DEVIATION 0.32 • n=5 Participants	18.07 years STANDARD_DEVIATION 0.44 • n=7 Participants	18.06 years STANDARD_DEVIATION 0.45 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	397 Participants n=5 Participants	396 Participants n=7 Participants	793 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	397 Participants n=5 Participants	396 Participants n=7 Participants	793 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Vietnam	397 participants n=5 Participants	396 participants n=7 Participants	793 participants n=5 Participants

PRIMARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics Baseline	23 Participants	32 Participants
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics Immediately post-intervention	46 Participants	35 Participants
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics 6 months post-intervention	39 Participants	31 Participants

PRIMARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics Baseline	41 Participants	48 Participants
Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics Immediately post-intervention	65 Participants	47 Participants
Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics 6 months post-intervention	64 Participants	51 Participants

PRIMARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Number of Participants Reporting Non-contact Sexual Violence Baseline	90 Participants	99 Participants
Number of Participants Reporting Non-contact Sexual Violence Immediately post-intervention	70 Participants	56 Participants
Number of Participants Reporting Non-contact Sexual Violence 6 months post-intervention	65 Participants	55 Participants

PRIMARY outcome

Timeframe: Six months following baseline

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Number of Participants Reporting Prosocial Bystander Behavior Baseline	258 Participants	258 Participants
Number of Participants Reporting Prosocial Bystander Behavior 6 months post-intervention	170 Participants	203 Participants

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Knowledge of Legal Definitions of Assault and Rape Scale Score Baseline	16.94 score on a scale Standard Deviation 3.72	17.02 score on a scale Standard Deviation 3.52
Knowledge of Legal Definitions of Assault and Rape Scale Score Immediately post-intervention	18.01 score on a scale Standard Deviation 4.31	18.86 score on a scale Standard Deviation 4.02
Knowledge of Legal Definitions of Assault and Rape Scale Score 6 months post-intervention	18.43 score on a scale Standard Deviation 4.51	18.58 score on a scale Standard Deviation 5.05

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Knowledge of Informed Consent to Have Sex Score Baseline	34.33 score on a scale Standard Deviation 5.31	35.05 score on a scale Standard Deviation 5.83
Knowledge of Informed Consent to Have Sex Score Immediately post-intervention	33.94 score on a scale Standard Deviation 6.06	35.81 score on a scale Standard Deviation 7.68
Knowledge of Informed Consent to Have Sex Score 6 months post-intervention	33.64 score on a scale Standard Deviation 6.51	35.54 score on a scale Standard Deviation 7.50

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Gender Roles Score Baseline	38.34 score on a scale Standard Deviation 7.14	38.82 score on a scale Standard Deviation 7.53
Gender Roles Score Immediately post-intervention	36.15 score on a scale Standard Deviation 8.08	37.21 score on a scale Standard Deviation 9.10
Gender Roles Score 6 months post-intervention	35.43 score on a scale Standard Deviation 8.72	36.77 score on a scale Standard Deviation 9.61

SECONDARY outcome

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

Population: Data for this outcome were not collected as the items performed poorly during pilot testing and this questionnaire was not administered to study participants.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Sexual Coercion Score Baseline	5.74 score on a scale Standard Deviation 5.59	5.76 score on a scale Standard Deviation 5.69
Sexual Coercion Score Immediately post-intervention	5.61 score on a scale Standard Deviation 5.71	6.45 score on a scale Standard Deviation 6.39
Sexual Coercion Score 6 months post-intervention	5.54 score on a scale Standard Deviation 5.74	5.90 score on a scale Standard Deviation 6.18

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Sexual Violence Myths Score Baseline	40.38 score on a scale Standard Deviation 7.83	40.89 score on a scale Standard Deviation 8.47
Sexual Violence Myths Score Immediately post-intervention	39.95 score on a scale Standard Deviation 9.02	43.01 score on a scale Standard Deviation 11.37
Sexual Violence Myths Score 6 months post-intervention	41.61 score on a scale Standard Deviation 10.13	44.34 score on a scale Standard Deviation 12.68

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Alcohol and Consent Score Baseline	14.57 score on a scale Standard Deviation 2.88	15.04 score on a scale Standard Deviation 2.95
Alcohol and Consent Score Immediately post-intervention	14.18 score on a scale Standard Deviation 2.77	15.45 score on a scale Standard Deviation 3.38
Alcohol and Consent Score 6 months post-intervention	14.30 score on a scale Standard Deviation 2.91	15.06 score on a scale Standard Deviation 3.52

SECONDARY outcome

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

Population: This analysis includes participants who completed the assessments at the indicated time point.

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.

Outcome measures

Outcome measures
Measure	Health Education Control Condition n=397 Participants Participants in the control arm received a health promotion program where they watched six 30-minute web-based serial drama modules designed to promote health.	RealConsent n=396 Participants Participants randomized to this study arm received the adapted program of RealConsent. The RealConsent 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 viewed six 30-minute modules designed to prevent sexual violence in young men.
Rape Empathy Score Baseline	11.61 score on a scale Standard Deviation 2.66	11.46 score on a scale Standard Deviation 2.73
Rape Empathy Score Immediately post-intervention	11.41 score on a scale Standard Deviation 2.99	12.01 score on a scale Standard Deviation 3.27
Rape Empathy Score 6 months post-intervention	11.64 score on a scale Standard Deviation 3.17	11.97 score on a scale Standard Deviation 3.47

Adverse Events

Health Education Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RealConsent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kathryn Yount

Emory University

Phone: 404-727-8511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place