实施全球共识以防止男大学生性暴力的策略 (SCALE)
SCALE:实施全球共识以防止大学男性性暴力的策略
研究概览
地位
条件
详细说明
性暴力在青春期普遍存在,增加了对健康造成长期有害影响的风险。 性暴力包括未经自由同意而针对他人实施的任何性行为。 所有性别都可能遭受性暴力,但在全球范围内,性暴力给女性带来的负担往往多于男性,而男性最常实施此类暴力。 青春期是性暴力的易发期,美国大约五分之一的女大学生遭遇过校园性侵犯,91%的受害者是女性。 人们对大学校园性暴力发生率知之甚少。 尽管如此,大型多国调查的估计证实,年轻男性报告的性暴力行为和年轻女性报告的性暴力受害率很高,包括在亚太地区。 在越南,从 2010 年到 2019 年,女性遭受伴侣终生性暴力的报告有所增加(10% 至 13%),尤其是 18-24 岁的女性(5% 至 14%)。 这种趋势可能反映了曝光度的变化以及讨论性和性暴力的更加开放。 此外,近十分之一的女性 (9%) 报告自 15 岁起就遭受过非伴侣性暴力,大部分实施者是非家庭男性熟人、同事或陌生人。 遭受性暴力的年轻女性患急性和慢性精神和身体健康问题的风险更高。
研究人员将使用范围、有效性、采用、实施和维护 (RE-AIM) 和 Proctor 等。框架和混合方法、比较中断时间序列 (CITS) 设计以比较实现;实施驱动因素和结果;实施有效性;以及低强度与高强度(LIS;HIS)实施策略的成本效益,以达成全球共识。
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kathryn Yount, PhD
- 电话号码:404-727-8511
- 邮箱:kathryn.yount@emory.edu
学习地点
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Can Tho、越南
- 招聘中
- Can Tho University of Medicine and Pharmacy (CTUMP)
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Da Nang、越南
- 招聘中
- Da Nang University of Medical Technology & Pharmacy (DUMTP)
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Haiphong、越南
- 招聘中
- Hai Phong University of Medicine and Pharmacy
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Hanoi、越南、116001
- 招聘中
- Hanoi Medical University
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接触:
- Tran Hung Minh, MD, MSc
- 电话号码:0243 5770261
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Ho Chi Minh City、越南
- 招聘中
- Ho Chi Minh City Medicine and Pharmacy University
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Ho Chi Minh City、越南
- 招聘中
- Hong Bang University
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Huế、越南、470000
- 招聘中
- Hue University of Medicine and Pharmacy
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
学生入学标准:
- 18-24岁,
- 自认为是异性恋或双性恋的男性(被女性吸引),
- 在越南北部、中部和南部的六所参与研究大学中的任何一所注册为一年级学生。
学生的排除标准:
- 成年人无法同意
- 尚未成年的个人(婴儿、儿童、青少年)
教师纳入标准:
- 六所参与研究大学的所有注册讲师将有资格参加第一年、第三年和第五年的气候调查。
教师的排除标准:
- 没有任何
领导者的纳入标准:
- 每个参与研究大学的研究人员的推荐
- 了解 GlobalConsent 的实施环境和实施。
领导者的排除标准:
- 没有任何
实施团队的纳入标准:
- 经相关研究人员鉴定。
实施团队的排除标准:
- 没有任何
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:学生
任一随机分组的学生都将成为 GlobalConsent 的积极消费者,并通过电子邮件介绍该计划、流程、交付时间表、数据收集程序和同意。
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LIS 小组的学生将收到 GlobalConsent 的基本实施策略,该策略通常用于在美国大学提供在线课程,并以预定频率发送 12 周的电子邮件/短信完成提醒。
其他名称:
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.
其他名称:
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实验性的:学院
教师将获得基于大学随机化实施策略组的教育材料。
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其他名称:
被动访问基于网络的教育材料
其他名称:
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实验性的:领导者
领导者将收到基于实施策略组的特定地点(大学)邀请和材料。
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其他名称:
其他名称:
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实验性的:实施团队成员
实施团队成员将根据大学特定的实施策略小组被动访问基于网络的材料和培训。
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其他名称:
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Students' Reported Prosocial Bystander Behavior
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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残疾评估和时间表
大体时间:基线
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仅限学生:残疾评估将使用世界卫生组织残疾评估表 2.0 (WHODAS 2.0) 进行评估,这是一种适用于所有疾病的健康和残疾通用评估工具,包括精神、神经和成瘾性疾病,适用于临床和一般人群设置。 它是衡量六个领域的残疾程度和功能的工具。 答案按照从 0(无)到 4(极端或不能做)的等级对每个问题进行评分。 评分方法有简单评分、复杂评分、平均评分三种。 简单分数是每个问题的评分之和。 复杂分数是评分之和乘以权重因子。 平均分是每个领域评分的平均值。 |
基线
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诊断和统计手册 (DSM)-5 交叉症状测量
大体时间:基线
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仅限学生:DSM-5 自评 1 级交叉症状测量 - 成人是一款旨在评估对各种精神病诊断非常重要的心理健康领域的工具。
它由 23 个问题组成,评估 13 个精神领域,例如抑郁、焦虑、躯体症状等。
该措施中的每个项目均按 5 分制评分(0 = 无或根本没有;1 = 轻微或罕见,少于一两天;2 = 轻微或数天;3 = 中等或超过一半)天;4=严重或几乎每天)。
对某个领域内的任何项目的温和(即 2)或更高评级可能会指导额外的询问和后续行动,以确定是否有必要对该领域进行更详细的评估。
在特定领域持续高分可能表明个体有明显的问题症状,可能需要进一步评估、治疗和随访
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基线
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酒精障碍知识/酒精对认知的影响
大体时间:基线,每6个月,最多30个月。
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仅学生:此表格询问受访者对5个与酒精有关的问题的共识或分歧,重点是决策,行为和性暴力。
它使用从“完全不同意”到“完全同意”的5点李克特评估协议或分歧。
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基线,每6个月,最多30个月。
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Perceptions of Sexual Violence form at their respective university
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
合作者
调查人员
- 首席研究员:Kathryn Yount, PhD、Emory University
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY00006481
- 1R01MH133259 (美国 NIH 拨款/合同)
- 2025P011593 (其他标识符:Emory Insight Humans IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.