SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,439
- 试验地点
- 12
- 主要终点
- Students' Reported Prosocial Bystander Behavior
研究概览
简要总结
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 seven 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 the best strategies for launching GlobalConsent at scale, addressing a sex-differentiated risk factor in adolescence, and thereby improving a range of health outcomes into adulthood.
详细描述
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 sexes 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 the 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Students:
- •18 and older
- •Men who self-identify as heterosexual or bisexual (who are attracted to women),
- •Enrolled as first-year students in any of the seven participating study universities in North, Central, and South Vietnam.
排除标准
- •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 seven participating study universities will be eligible to participate in the faculty surveys in years 1, 4, and
- •Exclusion Criteria for Faculty:
- •Inclusion Criteria for Leaders:
- •Recommendation of study staff at each participating study university
- •Knowledge about the implementation landscape and implementation of GlobalConsent.
- •Exclusion Criteria for Leaders:
- •Inclusion Criteria for Implementation Teams:
- •Identified by relevant study staff.
- •Exclusion Criteria for Implementation Teams:
研究组 & 干预措施
Faculty
Faculty will receive access to educational material based on the university randomization implementation strategies group.
干预措施: Low-intensity implementation strategies (LIS) for Faculty (Other)
Implementation Team Members
Implementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group.
干预措施: Low-intensity implementation strategies (LIS) Implementation Team Members (Other)
Students
Students in either randomization group will become active consumers of GlobalConsent with an email introduction to the program, process, delivery schedule, data collection procedures, and consent.
干预措施: High-intensity implementation strategies (HIS)-Students (Behavioral)
Students
Students in either randomization group will become active consumers of GlobalConsent with an email introduction to the program, process, delivery schedule, data collection procedures, and consent.
干预措施: Low-intensity implementation strategies (LIS) for Students (Behavioral)
Faculty
Faculty will receive access to educational material based on the university randomization implementation strategies group.
干预措施: High-intensity implementation strategies (HIS) for Faculty (Other)
Leaders
Leaders will receive site-specific (University) invitations and material based on the implementation strategies group.
干预措施: High-intensity implementation strategies (HIS) for Leaders (Other)
Leaders
Leaders will receive site-specific (University) invitations and material based on the implementation strategies group.
干预措施: Low-intensity implementation strategies (LIS) for Leaders (Other)
Implementation Team Members
Implementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group.
干预措施: High-intensity implementation strategies (HIS) for Implementation Team Members (Other)
结局指标
主要结局
Students' Reported Prosocial Bystander Behavior
时间窗: Baseline, every 6 months up to 30 months
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.
Students' reported Sexually Violent Behavior
时间窗: Baseline, every 6 months up to 30 months
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 every six months for up to 30 months.
Students' Reported Prosocial Bystander Behavior
时间窗: Baseline (month 10), every 6 months up to 30 months
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.
Students' reported Sexually Violent Behavior
时间窗: Baseline (month 10), every 6 months up to 30 months
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 every six months for up to 30 months.
次要结局
- Perceptions of Sexual Violence form at their respective university(Baseline and up to 49 months)
- Implementation Team Scale for staff and supervisors(Baseline, month 15, month 18, and month 42)
- Cultural Exchange Inventory(Baseline, month 15, month 18, and month 42)
- College Date Rape Attitudes & Behaviors Scale(Baseline, month 15, month 18, and month 42)
- Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students(Baseline and up to 49 months)
- Acceptability, Feasibility, and Appropriateness of GlobalConsent(Baseline and up to 49 months)
- Sexual Violence Legality and Harm (Information about Sexual Activity)(Baseline and up to 49 months)
- Active Consent (Information about Sexual Consent)(Baseline and up to 49 months)
- Rejection of Rape Myths (Attitudes about Sexual Situations)(Baseline and up to 49 months)
- Perceptions of Campus Attittudes(Baseline and up to 49 months)
- Alcohol Impairment Knowledge/Effects of Alcohol on Cognition(Baseline, every 6 months for up to 30 months.)
- Empathy for Rape Victims(Baseline, every 6 months for up to 30 months.)
- Sexual Communication Attitudes(Baseline, every 6 months for up to 30 months.)
- Bystander Self-Efficacy(Baseline, every 6 months for up to 30 months.)
- Bystander Intention to Intervene (Readiness to Intervene)(Baseline, every 6 months for up to 30 months.)
- Severity Measure for Depression(Baseline)
- Generalized Anxiety Disorder(Baseline)
- Disability Assessment and Schedule(Baseline)
- Diagnostic and Statistical Manual (DSM)-5 Cross Cutting Symptom Measure(Baseline)
- Students' Proactive Bystander Behavior Scale(Baseline, every 6 months up to 30 months)
- Students' Reactive Bystander Action Scale(Baseline, every 6 months up to 30 months)
- Implementation Team Scale for staff and supervisors(Baseline, month 15, month 18, and month 42)
- Perceptions of Sexual Violence form at their respective university(Baseline and up to 49 months)
- Cultural Exchange Inventory(Baseline, month 15, month 18, and month 42)
- College Date Rape Attitudes & Behaviors Scale(Baseline, month 15, month 18, and month 42)
- Severity Measure for Depression(Baseline)
- Generalized Anxiety Disorder(Baseline)
- Disability Assessment and Schedule(Baseline)
- Diagnostic and Statistical Manual (DSM)-5 Cross Cutting Symptom Measure(Baseline)
- Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students(Baseline and up to 49 months)
- Acceptability, Feasibility, and Appropriateness of GlobalConsent(Baseline and up to 49 months)
- Sexual Violence Legality and Harm (Information about Sexual Activity)(Baseline and up to 49 months)
- Active Consent (Information about Sexual Consent)(Baseline and up to 49 months)
- Rejection of Rape Myths (Attitudes about Sexual Situations)(Baseline and up to 49 months)
- Perceptions of Campus Attitudes(Baseline and up to 49 months)
- Perceptions of Sexual Violence form at their respective university(Baseline (month 10) and up to 49 months)
- Implementation Team Scale for staff and supervisors(Baseline, month 25, month 29, and month 32)
- Cultural Exchange Inventory(Baseline, month 25, month 29, and month 32)
- College Date Rape Attitudes & Behaviors Scale(Baseline, month 25, month 29, and month 32)
- Empathy for Rape Victims(Baseline (month 10), every 6 months for up to 30 months.)
- Sexual Communication Attitudes(Baseline (month10), every 6 months for up to 30 months.)
- Bystander Self-Efficacy(Baseline (month 10), every 6 months for up to 30 months.)
- Bystander Intention to Intervene (Readiness to Intervene)(Baseline (month 10), every 6 months for up to 30 months.)
- Severity Measure for Depression(Baseline (month 10), every 6 months for up to 30 months.)
- Generalized Anxiety Disorder(Baseline (month 10), every 6 months for up to 30 months.)
- Students' Proactive Bystander Behavior Scale(Baseline (month 10), every 6 months up to 30 months)
- Students' Reactive Bystander Action Scale(Baseline (month 10), every 6 months up to 30 months)
研究者
Kathryn Yount
Professor of Global Health
Emory University