Violence, SexualSCALENCT06443541
Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
A study testing High-intensity implementation strategies (HIS)-Students, Low-intensity implementation strategies (LIS) for Students and High-intensity implementation strategies (HIS) for Faculty in people with Violence, Sexual, run by Emory University at 7 sites in Vietnam.
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 seven universities across Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Violence, Sexual
- What is being tested?
- High-intensity implementation strategies (HIS)-Students, Low-intensity implementation strategies (LIS) for Students and High-intensity implementation strategies (HIS) for Faculty
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,439 participants
- Where
- 7 sitesVietnam
- Study dates
- 27 Mar 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Recommendation of study staff at each participating study university
- Knowledge about the implementation landscape and implementation of GlobalConsent.
- Identified by relevant study staff.
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- None
- None
- None
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Vietnam7 sites, 7 recruiting
- Recruiting
Can Tho University of Medicine and Pharmacy (CTUMP)
Can Tho
- Recruiting
Da Nang University of Medical Technology & Pharmacy (DUMTP)
Da Nang
- Recruiting
Hai Phong University of Medicine and Pharmacy
Haiphong
- Recruiting
Hanoi Medical University
Hanoi, 116001
Tran Hung Minh, MD, MSc, 0243 5770261
- Recruiting
Ho Chi Minh City Medicine and Pharmacy University
Ho Chi Minh City
- Recruiting
Hong Bang University
Ho Chi Minh City
- Recruiting
Hue University of Medicine and Pharmacy
Huế, 470000
About this study
Official title: SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
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.
Read the detailed 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 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.
- Conditions
- Violence, Sexual
- Being tested
- High-intensity implementation strategies (HIS)-Students, Low-intensity implementation strategies (LIS) for Students, High-intensity implementation strategies (HIS) for Faculty, Low-intensity implementation strategies (LIS) for Faculty, High-intensity implementation strategies (HIS) for Leaders
- Keywords
- Behavioral Intervention, GlobalConsent, Sexual Violence
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity implementation strategies (HIS)-StudentsBehavioural
Also called HIS-Students
Students 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 StudentsBehavioural
Also called LIS-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.
High-intensity implementation strategies (HIS) for FacultyOther
Also called HIS-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 FacultyOther
Also called LIS-Faculty
Passive access to web-based educational materials
High-intensity implementation strategies (HIS) for LeadersOther
Also called HIS-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 LeadersOther
Also called LIS-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 MembersOther
Also called HIS-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 MembersOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Students | Experimental | 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. Receives: Behavioral: High-intensity implementation strategies (HIS)-Students; Behavioral: Low-intensity implementation strategies (LIS) for Students |
| Faculty | Experimental | Faculty will receive access to educational material based on the university randomization implementation strategies group. Receives: Other: High-intensity implementation strategies (HIS) for Faculty; Other: Low-intensity implementation strategies (LIS) for Faculty |
| Leaders | Experimental | Leaders will receive site-specific (University) invitations and material based on the implementation strategies group. Receives: Other: High-intensity implementation strategies (HIS) for Leaders; Other: Low-intensity implementation strategies (LIS) for Leaders |
| Implementation Team Members | Experimental | Implementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group. Receives: Other: High-intensity implementation strategies (HIS) for Implementation Team Members; Other: Low-intensity implementation strategies (LIS) Implementation Team Members |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (month 10), every 6 months up to 30 months
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.
Measured: Baseline (month 10), every 6 months up to 30 months
Secondary outcomes (21)
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
Measured: Baseline (month 10) and up to 49 months
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).
Measured: Baseline, month 25, month 29, and month 32
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.
Measured: Baseline, month 25, month 29, and month 32
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.
Measured: Baseline, month 25, month 29, and month 32
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 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
Measured: Baseline and up to 49 months
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 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
Measured: Baseline and up to 49 months
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 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
Measured: Baseline and up to 49 months
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 scale ranging from "totally disagree" to "totally agree". It includes statements such as "If a person consents to 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 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
Measured: Baseline and up to 49 months
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 scale 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 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
Measured: Baseline and up to 49 months
Perceptions of Campus Attitudes
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 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, 34 months, and 49 months
- Leaders: Baseline and 41 months
- Implementation Team: Baseline, month 25, month 29, and month 32
Measured: Baseline and up to 49 months
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".
Measured: Baseline, every 6 months for up to 30 months.
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.
Measured: Baseline (month 10), every 6 months for up to 30 months.
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."
Measured: Baseline (month10), every 6 months for up to 30 months.
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.
Measured: Baseline (month 10), every 6 months for up to 30 months.
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.
Measured: Baseline (month 10), every 6 months for up to 30 months.
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.
Measured: Baseline (month 10), every 6 months for up to 30 months.
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
Measured: Baseline (month 10), every 6 months for up to 30 months.
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.
Measured: Baseline
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
Measured: Baseline
Students' Proactive Bystander Behavior Scale
This scale asks respondents to indicate whether and how often they completed proactive bystander behavior actions in the last 6 months (the time between each survey wave). Behaviors include "I have encouraged others to learn more and get involved in preventing sexual or dating violence," and "I have told guys not to talk about women in sexually degrading ways," and response options for each statement are (0) No, I have not done this in the last 6 months, (1) Yes, once in the last 6 months, and (2) Yes, more than once in the last 6 months.
Measured: Baseline (month 10), every 6 months up to 30 months
Students' Reactive Bystander Action Scale
This scale asks respondents whether and how often they completed reactive bystander behavior actions in the last 6 months (the time between each survey wave). Actions include "I have expressed concern or offered help to a woman who said she had an unwanted sexual experience but didn't call it 'rape'," "I have reported formally to an authority a guy who used physical force against a women," and "I have intervened with a guy's action because I wanted to stop an act of sexual violence." Responses options for each statement are (0) I experienced this situation in the last 6 months and did NOT act, (1) Yes, once in the last 6 months, (2) Yes, more than once in the last 6 months, and (9) I did NOT experience any situation like this in the last 6 months.
Measured: Baseline (month 10), every 6 months up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start27 Mar 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Violence, SexualStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster-randomized design assigns seven universities to High-intensity implementation strategies (HIS) or Lower-intensity (LIS) implementation strategies to deliver GlobalConsent education.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,439 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Center for Creative Initiatives in Health and Population, Georgia State University
- Responsible party
- Principal investigator, Kathryn Yount, Emory University
- Investigators
- Kathryn Yount, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443541
- Sponsor's protocol ID
- STUDY00006481
- Other IDs
- 1R01MH133259, 2025P011593
- Acronym
- SCALE
- Status last verified
- Jul 2026
- First submitted
- 15 May 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share three waves of fully deidentified panel data with faculty and six waves of fully deidentified panel data with students.
Publications
Yount KM, Whitaker D, Fang X, Trang QT, Macaulay M, Hung MT. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): Study Protocol for a National Implementation Trial. Res Sq [Preprint]. 2024 Sep 10:rs.3.rs-4745916. doi: 10.21203/rs.3.rs-4745916/v1.
PubMed 39315253Yount KM, Whitaker DJ, Fang X, Trang QT, Macaulay M, Minh TH. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): study protocol for a national implementation trial. Trials. 2024 Aug 29;25(1):571. doi: 10.1186/s13063-024-08401-5.
PubMed 39210388
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCALE: Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men
- ClinicalTrials.gov ID
- NCT06443541
- Acronym / sponsor ID
- SCALE / STUDY00006481
- Conditions
- Violence, Sexual
- Keywords
- Behavioral Intervention, GlobalConsent, Sexual Violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,439 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Center for Creative Initiatives in Health and Population, Georgia State University
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This cluster-randomized design assigns seven universities to High-intensity implementation strategies (HIS) or Lower-intensity (LIS) implementation strategies to deliver GlobalConsent education.
| Arm | Type | Receives |
|---|---|---|
| Students | Experimental | Behavioral: High-intensity implementation strategies (HIS)-Students, Behavioral: Low-intensity implementation strategies (LIS) for StudentsStudents 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. |
| Faculty | Experimental | Other: High-intensity implementation strategies (HIS) for Faculty, Other: Low-intensity implementation strategies (LIS) for FacultyFaculty will receive access to educational material based on the university randomization implementation strategies group. |
| Leaders | Experimental | Other: High-intensity implementation strategies (HIS) for Leaders, Other: Low-intensity implementation strategies (LIS) for LeadersLeaders will receive site-specific (University) invitations and material based on the implementation strategies group. |
| Implementation Team Members | Experimental | Other: High-intensity implementation strategies (HIS) for Implementation Team Members, Other: Low-intensity implementation strategies (LIS) Implementation Team MembersImplementation team members will receive passive access to web-based materials and training according to the university-specific implementation strategies group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
- Recommendation of study staff at each participating study university
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- None
- None
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity implementation strategies (HIS)-StudentsAlso: HIS-StudentsStudents 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. | Behavioural | Students |
| Low-intensity implementation strategies (LIS) for StudentsAlso: LIS-StudentsStudents 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. | Behavioural | Students |
| High-intensity implementation strategies (HIS) for FacultyAlso: HIS-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) | Other | Faculty |
| Low-intensity implementation strategies (LIS) for FacultyAlso: LIS-FacultyPassive access to web-based educational materials | Other | Faculty |
| High-intensity implementation strategies (HIS) for LeadersAlso: HIS-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) | Other | Leaders |
| Low-intensity implementation strategies (LIS) for LeadersAlso: LIS-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 | Other | Leaders |
| High-intensity implementation strategies (HIS) for Implementation Team MembersAlso: HIS-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 | Other | Implementation Team Members |
| Low-intensity implementation strategies (LIS) Implementation Team MembersAlso: 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 | Other | Implementation Team Members |
Primary outcome
Students' Reported Prosocial Bystander Behavior
Time frame: 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
Time frame: 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.
21 secondary outcomes
Perceptions of Sexual Violence form at their respective university
Time frame: Baseline (month 10) and up to 49 months
Implementation Team Scale for staff and supervisors
Time frame: Baseline, month 25, month 29, and month 32
Cultural Exchange Inventory
Time frame: Baseline, month 25, month 29, and month 32
College Date Rape Attitudes & Behaviors Scale
Time frame: Baseline, month 25, month 29, and month 32
Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students
Time frame: Baseline and up to 49 months
Acceptability, Feasibility, and Appropriateness of GlobalConsent
Time frame: Baseline and up to 49 months
Sexual Violence Legality and Harm (Information about Sexual Activity)
Time frame: Baseline and up to 49 months
Active Consent (Information about Sexual Consent)
Time frame: Baseline and up to 49 months
Rejection of Rape Myths (Attitudes about Sexual Situations)
Time frame: Baseline and up to 49 months
Perceptions of Campus Attitudes
Time frame: Baseline and up to 49 months
Alcohol Impairment Knowledge/Effects of Alcohol on Cognition
Time frame: Baseline, every 6 months for up to 30 months.
Empathy for Rape Victims
Time frame: Baseline (month 10), every 6 months for up to 30 months.
Sexual Communication Attitudes
Time frame: Baseline (month10), every 6 months for up to 30 months.
Bystander Self-Efficacy
Time frame: Baseline (month 10), every 6 months for up to 30 months.
Bystander Intention to Intervene (Readiness to Intervene)
Time frame: Baseline (month 10), every 6 months for up to 30 months.
Severity Measure for Depression
Time frame: Baseline (month 10), every 6 months for up to 30 months.
Generalized Anxiety Disorder
Time frame: Baseline (month 10), every 6 months for up to 30 months.
Disability Assessment and Schedule
Time frame: Baseline
Diagnostic and Statistical Manual (DSM)-5 Cross Cutting Symptom Measure
Time frame: Baseline
Students' Proactive Bystander Behavior Scale
Time frame: Baseline (month 10), every 6 months up to 30 months
Students' Reactive Bystander Action Scale
Time frame: Baseline (month 10), every 6 months up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 39315253Yount KM, Whitaker D, Fang X, Trang QT, Macaulay M, Hung MT. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): Study Protocol for a National Implementation Trial. Res Sq [Preprint]. 2024 Sep 10:rs.3.rs-4745916. doi: 10.21203/rs.3.rs-4745916/v1.
- Derived from this study: PubMed 39210388Yount KM, Whitaker DJ, Fang X, Trang QT, Macaulay M, Minh TH. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): study protocol for a national implementation trial. Trials. 2024 Aug 29;25(1):571. doi: 10.1186/s13063-024-08401-5.
- Individual participant dataSharing planned: Yes. The research team will share three waves of fully deidentified panel data with faculty and six waves of fully deidentified panel data with students.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn Yount, PhD principal investigator
Emory University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity implementation strategies (HIS)-Students, Low-intensity implementation strategies (LIS) for Students and High-intensity implementation strategies (HIS) for Faculty in people with Violence, Sexual, run by Emory University at 7 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Yount, PhD (404-727-8511, kathryn.yount@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Students' Reported Prosocial Bystander Behavior (time frame: Baseline (month 10), every 6 months up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.