Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
ConditionViolence, Sexual
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
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 5.
None
Trial design
Design model
Parallel
Treatments tested in this trial
High-intensity implementation strategies (HIS)-Students
BehavioralStudents in the HIS group will receive educational outreach in a pre-implementation 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
BehavioralStudents 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.
High-intensity implementation strategies (HIS) for Faculty
Other intervention* 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
Other interventionPassive access to web-based educational materials
High-intensity implementation strategies (HIS) for Leaders
Other intervention* 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
Other intervention* 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
Other intervention* 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
Other intervention* 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
Treatment groups
3,439 Participants
are divided into 4 treatment groupsGroup A: StudentsExperimental treatment 2 interventions
Group B: FacultyExperimental treatment 2 interventions
Group C: LeadersExperimental treatment 2 interventions
Group D: Implementation Team MembersExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (month 10), every 6 months up to 30 months2
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 every six months for up to 30 months.
Time frame
Baseline (month 10), every 6 months up to 30 monthsSecondary outcomes
1
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 scale ranging from "Totally disagree" to "Totally agree." Surveys will be provided to all groups at different time points as follows: * Students: Baseline (month 10), every 6 months up to 30 months * Faculty: Baseline, 32 months, and 44 months * Leaders: Baseline and 41 months * Implementation Team: Baseline, month 25, month 29, and month 32
Time frame
Baseline (month 10) and up to 49 months2
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).
Time frame
Baseline, month 25, month 29, and month 323
Cultural Exchange Inventory
For implementation team members only: The Cultural Exchange Inventory assesses the teamwork landscape of GlobalConsent implementation teams using 7 items. Respondents give their level of agreement, using a 5-point Likert scale 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.
Time frame
Baseline, month 25, month 29, and month 324
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.
Time frame
Baseline, month 25, month 29, and month 32Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Center for Creative Initiatives in Health and Population
Collaborator
Georgia State University
Collaborator
Source ClinicalTrials.gov