Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

Violence, Sexual Clinical Trial

— SCALE  

Official title:

SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443541
• Other study ID #: STUDY00006481
• Secondary ID: 1R01MH133259
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: February 2028

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: Kathryn Yount, PhD
• Phone: 404-727-8511
• Email: kathryn.yount[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project, SCALE, will be the first to compare lower-intensity (standard) and higher-intensity implementation strategies to deliver GlobalConsent-an efficacious web-based sexual violence prevention program-to men attending six universities across Vietnam. Following a rigorous, mixed-methods, comparative interrupted-time-series design, researchers will collect novel data to compare implementation fidelity, drivers and outcomes, effectiveness, and cost-effectiveness across implementation strategy groups. This partnership includes universities also engaged in a violence-prevention training grant (D43TW012188), offering an unparalleled opportunity for capacity strengthening and evidence generation to guide national leaders on best strategies for launching GlobalConsent at scale, to address a gendered risk factor in adolescence, and thereby, improve an array of health outcomes into adulthood.

Description:

Sexual violence is prevalent in adolescence and heightens the risk of harmful long-term health effects. Sexual violence includes any sexual act committed against a person without freely given consent. All genders may experience sexual violence, but sexual violence more often burdens women than men globally, and men most often perpetrate such violence. Adolescence is a period of vulnerability to sexual violence, with about one in five college women in the US experiencing a campus sexual assault and 91% of victims being women. Less is known about rates of sexual violence on college campuses. Still, estimates from large, multi-country surveys confirm that young men's reported sexually violent behavior and young women's reported sexual violence victimization are high, including in Asia/Pacific. In Vietnam, from 2010 to 2019, women's reports of lifetime sexual violence by a partner increased (10% to 13%), especially in women 18-24 years (5% to 14%). Such trends may reflect changing exposure and more openness to discuss sex and sexual violence. Also, nearly one in ten women (9%) report non-partner sexual violence since age 15, mostly perpetrated by non-family male acquaintances, co-workers, or strangers. Young women who are victims of sexual violence are at heightened risk of acute and chronic mental and physical health conditions. The researchers will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Proctor et al. frameworks and a mixed-methods, comparative interrupted time series (CITS) design to compare implementation; implementation drivers and outcomes; implementation effectiveness; and cost-effectiveness of lower-intensity vs higher-intensity (LIS; HIS) implementation strategies to deliver GlobalConsent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3439
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Students:

• 18-24 years old,
• Men who self-identify as heterosexual or bisexual (who are attracted to women),
• Enrolled as first-year students in any of the six participating study universities in North, Central, and South Vietnam.

Exclusion Criteria for Students:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)

Inclusion Criteria for Faculty:

• All registered lecturers at each of the six participating study universities will be eligible to participate in the climate surveys in years 1, 3, and 5.

Exclusion Criteria for Faculty:

• None

Inclusion Criteria for Leaders:

• Recommendation of study staff at each participating study university
• Knowledge about the implementation environment and implementation of GlobalConsent.

Exclusion Criteria for Leaders:

• None

Inclusion Criteria for Implementation Teams:

• Identified by relevant study staff.

Exclusion Criteria for Implementation Teams:

• None

Related Conditions & MeSH terms

• Violence, Sexual

Intervention

Behavioral:
• High-intensity implementation strategies (HIS)-Students
Students in the HIS group will receive educational outreach in a pre-implementation in-person orientation to GlobalConsent, covering similar topics and three monthly one-hour learning sessions during implementation in which technical questions about program access or progression can be addressed; more intensive intervention to enhance adherence with more frequent email/Short Message Service (SMS), completion reminders; and demand generation encouraging program completion.
• Low-intensity implementation strategies (LIS) for Students
Students in the LIS group will receive basic implementation strategies of the GlobalConsent often used to deliver online programs at US universities with email/SMS completion reminders with a predetermined frequency for 12 weeks.

Other:
• High-intensity implementation strategies (HIS) for Faculty
Passive access to web-based educational materials Town halls (3) with general faculty to define sexual violence; rates in young people; acute/chronic effects over the life course; primary-prevention evidence-based interventions (EBIs)
• Low-intensity implementation strategies (LIS) for Faculty
Passive access to web-based educational materials
• High-intensity implementation strategies (HIS) for Leaders
Site-specific invitation to participate Passive access to web-based educational materials One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials Monthly emails from trained internal facilitators to university leaders with updates on implementation progress One post-implementation webinar to share anonymized findings (by IS group); discuss plan for sustainment (including guidance on how to handle reporting of sexual violence in existing university counseling centers)
• Low-intensity implementation strategies (LIS) for Leaders
Site-specific invitation to participate Passive access to web-based educational materials One pre-implementation webinar to define sexual violence; rates among young people in Vietnam; acute/chronic effects over life course; primary-prevention EBIs; recap of project description and collaboration; share GlobalConsent website for passive access to educational materials
• High-intensity implementation strategies (HIS) for Implementation Team Members
Passive access to web-based educational materials In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual In-person leadership training to champion GlobalConsent with internal stakeholders (leaders, implementation teams, faculty, students); leadership styles; managing teams; influence without authority; managing conflict; emotional intelligence; negotiation; leading change Biweekly (six) 1-hr recorded quality-improvement team webinars to provide refresher training; assess implementation progress; assess modifications; build peer-network; provide anonymized data on implementation progress for discussion
• Low-intensity implementation strategies (LIS) Implementation Team Members
Passive access to web-based educational materials In-person technical training on campus-wide implementation of GlobalConsent; discussion and demonstration of GlobalConsent program; standardized implementation manual

Locations

Country	Name	City	State
Vietnam	Can Tho University of Medicine and Pharmacy (CTUMP)	C?n Tho
Vietnam	Da Nang University of Medical Technology & Pharmacy (DUMTP)	Da Nang
Vietnam	Hai Phong University of Medicine and Pharmacy	H?i Phòng
Vietnam	Hanoi Medical University	Hanoi
Vietnam	Ho Chi Minh City Medicine and Pharmacy University	Ho Chi Minh City
Vietnam	Hue University of Medicine and Pharmacy	Hu?

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Center for Creative Initiatives in Health and Population (CCIHP), Georgia State University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Students' Reported Prosocial Bystander Behavior	Students will be asked if they had engaged in any of seven prosocial bystander behaviors in the past 3 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 seven prosocial bystander behaviors at least once are presented here.	Baseline, quarterly up to 28 months
Primary	Students' reported Sexually Violent Behavior	The Sexual Experiences Survey (SES) is an assessment tool used to measure the prevalence of sexual aggression. It is designed to measure the frequency and severity of sexual aggression acts committed by an individual. The SES is a self-report questionnaire developed by researchers at the University of Michigan. The Sexual Experiences Survey - Short Form Victimization is a multi-item measure to assess unwanted sexual victimization. Surveys will be provided quarterly for up to 28 months.	Baseline, quarterly up to 28 months
Secondary	Perceptions of Sexual Violence form at their respective university	Perceptions of sexual violence will be assessed by respondents rating their level of agreement with 3 statements regarding the frequency and impact of sexual violence at their university using a 5-point Likert ranging from "Totally disagree" to "Totally agree."; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Implementation Team Scale for staff and supervisors	Leadership in implementation teams is assessed using two scales, one for implementation team supervisors, and one for implementation team staff. Each scale has 13 items and uses a 5-point Likert ranging from "Totally disagree" to "Totally agree" to assess respondent's agreement on statements about their team supervisor (for staff) or themselves (for supervisors).	Baseline, month 15, month 18, and month 42
Secondary	Cultural Exchange Inventory	For implementation team members only: The cultural exchange inventory assesses the teamwork environment of GlobalConsent implementation teams using 7 items. Respondents give their level of agreement, using a 5-point Likert ranging from "Totally disagree" to "Totally agree," on statements such as "The implementation team is working well together to implement GlobalConsent" and "My colleagues are devoting a lot of time and energy to maintain the collaboration of the implementation team.	Baseline, month 15, month 18, and month 42
Secondary	College Date Rape Attitudes & Behaviors Scale	For implementation team members only: The College Date Rape Attitude Survey (CDRAS), a measure intended to assess attitudes related to the risk of committing rape in adolescents and young adults, the CDRAS measures four rape-related attitudes: Entitlement, Blame Shifting, Traditional Roles, and Overwhelming Sexual Arousal. The CDRAS contains 20 items measuring attitudes toward date rape. All items require responses on a 5-point Likert scale. The responses for the attitude scale are strongly agree, agree, neutral, disagree, and strongly disagree. Scoring is reversed for appropriate items; so that high scores (5) always correspond to the most desirable (rape-related) responses.	Baseline, month 15, month 18, and month 42
Secondary	Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students	This scale assesses respondents' attitudes towards sexual violence prevention programming by asking them to rate their level of agreement with 10 statements, such as "Implementing sexual violence prevention programming with students at our university is something I support," "...addresses a relevant problem among our students," "…would be easy for students to participate in." These statements will be rated using a 5-point Likert ranging from "Totally disagree" to "Totally agree."; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Acceptability, Feasibility, and Appropriateness of GlobalConsent	This scale assesses respondents' attitudes towards the GlobalConsent program specifically by asking them to rate their level of agreement or disagreement with 10 statements, such as "Implementing GlobalConsent with students at our university is something I support," "...addresses a relevant problem among our students," "…would be easy for students to participate in." these statements will be rated using a 5-point Likert ranging from "Totally disagree" to "Totally agree."; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Sexual Violence Legality and Harm (Information about Sexual Activity)	Knowledge of the law is assessed with 12 items where respondents indicate if they think the situations described are illegal (scored as 1), legal, but harmful (2), or legal and not harmful (3), with example items including "Forcing a person to have oral sex" and "Pressuring someone to have sex." Items will be 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 of the illegality and harms of sexual violence were coded as "0".; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Active Consent (Information about Sexual Consent)	This form adapted the Sexual Consent Scale to ask respondents to rate their level of agreement with 12 statements about sexual consent using a 5-point Likert ranging from "totally disagree" to "totally agree". It includes statements such as "If a person consents for sex, one can continue sexual contact even if the person changes their mind," and "Obtaining consent for sex is just as necessary in a long-term relationship as in a new relationship."; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Rejection of Rape Myths (Attitudes about Sexual Situations)	This form is a combination of the Illinois Rape Myth Acceptance Scale and the College Date Rape Attitudes & Behaviors Scale. This assesses attitudes towards sexual assault and rape by asking respondents to rate their level of agreement or disagreement with 15 statements using a 5-point Likert ranging from "totally disagree" to "totally agree". Statements include "If a woman dresses in a sexy dress, she is asking for sex," and "When guys rape, it is usually because of their strong desire for sex."; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Perceptions of Campus Climate	This form assesses the perceptions of respondents in their university's faculty and leaders' potential response to sexual violence on their university campus. Questions ask about behaviors of abuse, sexual assault, and stalking, and their level of agreement or disagreement with whether faculty and leaders would believe a student reporting experiencing these behaviors, respect a student who reported experiencing these behaviors or admire a student intervening in these behaviors. Agreement is assessed using a 5-point Likert ranging from "totally disagree" to "totally agree"; Surveys will be provided to all groups at different time points as below: Students: quarterly for up to 28 months.; Faculty: Baseline, 24 months, and 49 months; Leaders: Baseline and 36 months; Implementation Team: Baseline, month 15, month 18, and month 42	Baseline and up to 49 months
Secondary	Alcohol Impairment Knowledge/Effects of Alcohol on Cognition	Students only: This form asks respondents' agreement or disagreement on 5 alcohol-related questions focusing on decision-making, behavior, and sexual violence. It assesses agreement or disagreement using a 5-point Likert ranging from "totally disagree" to "totally agree".	Baseline, quarterly up to 28 months
Secondary	Empathy for Rape Victims	Students only: Empathy for rape victims will be assessed with a modified version of the Rape Empathy Scale (RES). This assessment includes 10 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 10 where higher scores indicate more empathy towards rape victims.	Baseline, quarterly up to 28 months
Secondary	Sexual Communication Attitudes	Students only: This is a 7-item scale measuring agreement or disagreement with statements focusing on sexual communication. Agreement and disagreement is assessed using a 5-point Likert ranging from "totally disagree" to "totally agree."	Baseline, quarterly up to 28 months
Secondary	Bystander Self-Efficacy	Students only: Bystander Self-Efficacy will be measured using the Bystander Efficacy Scale, which was developed for a project that evaluated the effectiveness of a sexual violence prevention program based on preventing antecedents to sexual violence by increasing prosocial bystander behavior. On this measure, participants are asked to indicate their confidence, on a 3-point scale, in performing each of 10 bystander behaviors (e.g., "Speak up to a guy who is making excuses for using physical force in a sexual relationship."). Scores are created by subtracting the mean of the 10 items from 100 to create a scale of perceived ineffectiveness; thus, higher scores indicate lesser effectiveness.	Baseline, quarterly up to 28 months
Secondary	Bystander Intention to Intervene (Readiness to Intervene)	Students only: Readiness to Intervene will be measured using three intent-to-help subscales.; Intent to Help Friend Scale: Sexual Abuse; Intent to Help Friend Scale: Intimate Partner Violence Intent to help is an attitude that is related to bystander action. Participants will be asked how likely they are to take different bystander actions.; The second Intent to Help subscale focuses on participants' intent to help strangers in both sexual abuse and intimate partner abuse situations.; Responses range from 1 (not at all likely) to 5 (extremely likely). The average is calculated from the answers across the items to score this measure.	Baseline, quarterly up to 28 months
Secondary	Severity Measure for Depression	Students only: Depression will be measured using the Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 is completed by the participant in minutes and is rapidly scored by a clinician. The PHQ-9 can also be administered repeatedly, which can reflect the improvement or the worsening of depression in response to treatment. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression.	Baseline
Secondary	Generalized Anxiety Disorder	Students will complete the Generalized Anxiety Disorder 7-item (GAD-7), which is a quick and easy tool to help identify patients with anxiety and monitor treatment response. The GAD-7 has been validated as a diagnostic tool and a severity assessment scale. The scale consists of 7 items. The total score can range from 0 to 21, and it indicates the severity of anxiety as follows: 0 to 4: Minimal anxiety 5 to 9: Mild anxiety 10 to 14: Moderate anxiety 15 to 21: Severe anxiety	Baseline
Secondary	Disability Assessment and Schedule	Students only: The Disability Assessment will be assessed by using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), which is a generic assessment instrument for health and disability used across all diseases, including mental, neurological and addictive disorders, applicable in both clinical and general population settings. It is a tool to measure the level of disability and functioning in six domains. The answers rate each question on a scale from 0 (none) to 4 (extreme or cannot do).; There are three scoring methods: simple score, complex score, or average score. The simple score is the sum of the ratings for each question. The complex score is the sum of the ratings multiplied by a weight factor. The average score is the mean of the ratings for each domain.	Baseline
Secondary	Diagnostic and Statistical Manual (DSM)-5 Cross Cutting Symptom Measure	Students only: The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult is a tool designed to assess mental health domains that are important across various psychiatric diagnoses. It consists of 23 questions that evaluate 13 psychiatric domains, such as depression, anxiety, somatic symptoms, and more. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). A mild (i.e., 2) or greater rating on any item within a domain may guide additional inquiry and follow-up to determine if a more detailed assessment for that domain is necessary. Consistently high scores on a particular domain may indicate significant and problematic symptoms for the individual that might warrant further assessment, treatment, and follow-up	Baseline