- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06443541
Strategier for implementering av globalt samtykke for å forhindre seksuell vold hos universitetsmenn (SCALE)
SKALA: Strategier for implementering av globalt samtykke for å forhindre seksuell vold hos universitetsmenn
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Atferdsmessig: Lavintensitetsimplementeringsstrategier (LIS) for studenter
- Annen: Høyintensive implementeringsstrategier (HIS) for fakultetet
- Annen: Lavintensitetsimplementeringsstrategier (LIS) for fakultetet
- Annen: Høyintensive implementeringsstrategier (HIS) for ledere
- Annen: Lavintensitetsimplementeringsstrategier (LIS) for ledere
- Annen: Høyintensive implementeringsstrategier (HIS) for implementeringsteammedlemmer
- Annen: Lav-intensitets implementeringsstrategier (LIS) Implementeringsteammedlemmer
- Atferdsmessig: High-intensity implementation strategies (HIS)-Students
Detaljert beskrivelse
Seksuell vold er utbredt i ungdomsårene og øker risikoen for skadelige langsiktige helseeffekter. Seksuell vold omfatter enhver seksuell handling begått mot en person uten fritt gitt samtykke. Alle kjønn kan oppleve seksuell vold, men seksuell vold belaster kvinner oftere enn menn globalt, og menn utøver oftest slik vold. Ungdomstiden er en periode med sårbarhet for seksuell vold, med omtrent én av fem collegekvinner i USA som opplever et seksuelt overgrep på campus og 91 % av ofrene er kvinner. Mindre er kjent om graden av seksuell vold på høyskoler. Likevel bekrefter estimater fra store undersøkelser i flere land at unge menns rapporterte seksuelle voldelige atferd og unge kvinners rapporterte seksuelle voldsoffer er høye, inkludert i Asia/Stillehavet. I Vietnam, fra 2010 til 2019, økte kvinners rapporter om livslang seksuell vold fra en partner (10 % til 13 %), spesielt hos kvinner 18–24 år (5 % til 14 %). Slike trender kan reflektere endret eksponering og mer åpenhet for å diskutere sex og seksuell vold. Nesten én av ti kvinner (9 %) rapporterer også om seksuell vold som ikke er partner siden 15-årsalderen, for det meste begått av mannlige bekjente, kolleger eller fremmede som ikke er familiemedlemmer. Unge kvinner som er ofre for seksuell vold har økt risiko for akutte og kroniske psykiske og fysiske helsetilstander.
Forskerne vil bruke Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) og Proctor et al. rammeverk og et komparativt avbrutt tidsseriedesign (CITS) med blandede metoder for å sammenligne implementering; implementeringsdrivere og resultater; implementeringseffektivitet; og kostnadseffektiviteten til implementeringsstrategier med lavere intensitet versus høyere intensitet (LIS; HIS) for å levere GlobalConsent.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kathryn Yount, PhD
- Telefonnummer: 404-727-8511
- E-post: kathryn.yount@emory.edu
Studiesteder
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Can Tho, Vietnam
- Rekruttering
- Can Tho University of Medicine and Pharmacy (CTUMP)
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Da Nang, Vietnam
- Rekruttering
- Da Nang University of Medical Technology & Pharmacy (DUMTP)
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Haiphong, Vietnam
- Rekruttering
- Hai Phong University of Medicine and Pharmacy
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Hanoi, Vietnam, 116001
- Rekruttering
- Hanoi Medical University
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Ta kontakt med:
- Tran Hung Minh, MD, MSc
- Telefonnummer: 0243 5770261
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Ho Chi Minh City, Vietnam
- Rekruttering
- Ho Chi Minh City Medicine and Pharmacy University
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Ho Chi Minh City, Vietnam
- Rekruttering
- Hong Bang University
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Huế, Vietnam, 470000
- Rekruttering
- Hue University of Medicine and Pharmacy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier for studenter:
- 18-24 år,
- Menn som identifiserer seg som heterofile eller bifile (som er tiltrukket av kvinner),
- Registrert som førsteårsstudenter ved noen av de seks deltakende studieuniversitetene i Nord-, Sentral- og Sør-Vietnam.
Ekskluderingskriterier for studenter:
- Voksne kan ikke samtykke
- Personer som ennå ikke er voksne (spedbarn, barn, tenåringer)
Inkluderingskriterier for fakultetet:
- Alle registrerte forelesere ved hvert av de seks deltakende studieuniversitetene vil være kvalifisert til å delta i klimaundersøkelsene i år 1, 3 og 5.
Ekskluderingskriterier for fakultetet:
- Ingen
Inkluderingskriterier for ledere:
- Anbefaling av studiepersonell ved hvert deltakende studieuniversitet
- Kunnskap om implementeringsmiljø og implementering av GlobalConsent.
Ekskluderingskriterier for ledere:
- Ingen
Inkluderingskriterier for implementeringsteam:
- Identifisert av relevant studiepersonell.
Ekskluderingskriterier for implementeringsteam:
- Ingen
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Studenter
Studenter i hver randomiseringsgruppe vil bli aktive forbrukere av GlobalConsent med en e-postintroduksjon til programmet, prosess, leveringsplan, datainnsamlingsprosedyrer og samtykke.
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Studenter i LIS-gruppen vil motta grunnleggende implementeringsstrategier for GlobalConsent som ofte brukes til å levere nettbaserte programmer ved amerikanske universiteter med påminnelser om fullføring av e-post/SMS med en forhåndsbestemt frekvens i 12 uker.
Andre navn:
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.
Andre navn:
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Eksperimentell: Fakultet
Fakultetet vil få tilgang til undervisningsmateriell basert på universitetets randomiseringsimplementeringsstrategigruppe.
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Andre navn:
Passiv tilgang til nettbasert undervisningsmateriell
Andre navn:
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Eksperimentell: Ledere
Ledere vil motta stedsspesifikke (universitet) invitasjoner og materiale basert på implementeringsstrategigruppen.
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Andre navn:
Andre navn:
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Eksperimentell: Medlemmer av implementeringsteamet
Medlemmer av implementeringsteamet vil få passiv tilgang til nettbasert materiell og opplæring i henhold til den universitetsspesifikke implementeringsstrategigruppen.
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Andre navn:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Students' Reported Prosocial Bystander Behavior
Tidsramme: Baseline (month 10), every 6 months up to 30 months
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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.
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Baseline (month 10), every 6 months up to 30 months
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Students' reported Sexually Violent Behavior
Tidsramme: Baseline (month 10), every 6 months up to 30 months
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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.
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Baseline (month 10), every 6 months up to 30 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Handikapvurdering og tidsplan
Tidsramme: Grunnlinje
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Kun studenter: Disability Assessment vil bli vurdert ved å bruke World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), som er et generisk vurderingsinstrument for helse og funksjonshemming brukt på tvers av alle sykdommer, inkludert psykiske, nevrologiske og vanedannende lidelser, som gjelder både kliniske og generelle befolkningsinnstillinger. Det er et verktøy for å måle nivået av funksjonshemming og funksjon i seks domener. Svarene vurderer hvert spørsmål på en skala fra 0 (ingen) til 4 (ekstremt eller kan ikke gjøre). Det er tre scoringsmetoder: enkel poengsum, kompleks poengsum eller gjennomsnittlig poengsum. Den enkle poengsummen er summen av vurderingene for hvert spørsmål. Den komplekse poengsummen er summen av vurderingene multiplisert med en vektfaktor. Gjennomsnittlig poengsum er gjennomsnittet av vurderingene for hvert domene. |
Grunnlinje
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Diagnostisk og statistisk håndbok (DSM)-5 Cross Cutting Symptom Measure
Tidsramme: Grunnlinje
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Kun studenter: DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult er et verktøy utviklet for å vurdere psykiske helsedomener som er viktige på tvers av ulike psykiatriske diagnoser.
Den består av 23 spørsmål som evaluerer 13 psykiatriske domener, som depresjon, angst, somatiske symptomer og mer.
Hvert element på tiltaket er vurdert på en 5-punkts skala (0 = ingen eller ikke i det hele tatt; 1 = liten eller sjelden, mindre enn en dag eller to; 2 = mild eller flere dager; 3 = moderat eller mer enn halvparten av dager; og 4 = alvorlig eller nesten hver dag).
En mild (dvs. 2) eller høyere vurdering av en vare innenfor et domene kan veilede ytterligere forespørsel og oppfølging for å avgjøre om en mer detaljert vurdering for det domenet er nødvendig.
Konsekvent høye skårer på et bestemt domene kan indikere betydelige og problematiske symptomer for individet som kan berettige ytterligere vurdering, behandling og oppfølging
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Grunnlinje
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Alkoholhemming Kunnskap/effekter av alkohol på erkjennelse
Tidsramme: Baseline, hver 6. måned i opptil 30 måneder.
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Bare studenter: Dette skjemaet stiller respondentenes avtale eller uenighet om 5 alkoholrelaterte spørsmål med fokus på beslutninger, atferd og seksuell vold.
Den vurderer enighet eller uenighet ved å bruke en 5-punkts Likert, alt fra "helt uenig" til "helt enig".
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Baseline, hver 6. måned i opptil 30 måneder.
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Perceptions of Sexual Violence form at their respective university
Tidsramme: Baseline (month 10) and up to 49 months
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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:
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Baseline (month 10) and up to 49 months
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Implementation Team Scale for staff and supervisors
Tidsramme: Baseline, month 25, month 29, and month 32
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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).
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Baseline, month 25, month 29, and month 32
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Cultural Exchange Inventory
Tidsramme: Baseline, month 25, month 29, and month 32
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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.
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Baseline, month 25, month 29, and month 32
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College Date Rape Attitudes & Behaviors Scale
Tidsramme: Baseline, month 25, month 29, and month 32
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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.
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Baseline, month 25, month 29, and month 32
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Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students
Tidsramme: Baseline and up to 49 months
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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:
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Baseline and up to 49 months
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Acceptability, Feasibility, and Appropriateness of GlobalConsent
Tidsramme: Baseline and up to 49 months
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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:
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Baseline and up to 49 months
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Sexual Violence Legality and Harm (Information about Sexual Activity)
Tidsramme: Baseline and up to 49 months
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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:
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Baseline and up to 49 months
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Active Consent (Information about Sexual Consent)
Tidsramme: Baseline and up to 49 months
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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:
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Baseline and up to 49 months
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Rejection of Rape Myths (Attitudes about Sexual Situations)
Tidsramme: Baseline and up to 49 months
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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:
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Baseline and up to 49 months
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Perceptions of Campus Attitudes
Tidsramme: Baseline and up to 49 months
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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:
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Baseline and up to 49 months
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Empathy for Rape Victims
Tidsramme: Baseline (month 10), every 6 months for up to 30 months.
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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.
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Baseline (month 10), every 6 months for up to 30 months.
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Sexual Communication Attitudes
Tidsramme: Baseline (month10), every 6 months for up to 30 months.
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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."
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Baseline (month10), every 6 months for up to 30 months.
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Bystander Self-Efficacy
Tidsramme: Baseline (month 10), every 6 months for up to 30 months.
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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.
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Baseline (month 10), every 6 months for up to 30 months.
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Bystander Intention to Intervene (Readiness to Intervene)
Tidsramme: Baseline (month 10), every 6 months for up to 30 months.
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Students only: Readiness to Intervene will be measured using three intent-to-help subscales.
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 (month 10), every 6 months for up to 30 months.
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Severity Measure for Depression
Tidsramme: Baseline (month 10), every 6 months for up to 30 months.
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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.
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Baseline (month 10), every 6 months for up to 30 months.
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Generalized Anxiety Disorder
Tidsramme: Baseline (month 10), every 6 months for up to 30 months.
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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 (month 10), every 6 months for up to 30 months.
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Students' Proactive Bystander Behavior Scale
Tidsramme: Baseline (month 10), every 6 months up to 30 months
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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.
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Baseline (month 10), every 6 months up to 30 months
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Students' Reactive Bystander Action Scale
Tidsramme: Baseline (month 10), every 6 months up to 30 months
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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.
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Baseline (month 10), every 6 months up to 30 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kathryn Yount, PhD, Emory University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Yount 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00006481
- 1R01MH133259 (U.S. NIH-stipend/kontrakt)
- 2025P011593 (Annen identifikator: Emory Insight Humans IRB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .