跳至主要内容
临床试验/NCT05185440
NCT05185440
招募中
不适用

Reducing Alcohol Involved Sexual Violence in Higher Education

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 2,400 人2023年6月12日

概览

阶段
不适用
干预措施
GIFTSS Training
疾病 / 适应症
Sexual Violence
发起方
University of Pittsburgh
入组人数
2400
试验地点
1
主要终点
Receipt of educational resource card
状态
招募中
最后更新
23天前

概览

简要总结

This cluster-randomized controlled trial across 28+ college campuses focuses on undergraduate college students at elevated risk for sexual violence and hazardous drinking (i.e., students with prior history of sexual violence, students who are sexual or gender minority, and students with disabilities). "Reducing Alcohol Involved Sexual violence in higher Education (RAISE)" is a longitudinal study that will test research-informed strategies to improve implementation of a prevention intervention in college health and counseling centers, integrate a safety decision aid (via computer or mobile device) to more directly target harm reduction among students particularly vulnerable to hazardous drinking and SV, and evaluate campus policies that increase accessibility and uptake of confidential services for students. This is the first study to situate a sexual violence prevention intervention in college health and counseling centers to address two significant public health concerns -- alcohol-involved sexual violence and hazardous drinking on college campuses.

详细描述

This is a collaborative study across 28+ college campuses focused on tailored harm reduction interventions to reduce risk for sexual violence (SV) among undergraduate college students receiving care from college health and counseling centers (CHCs). "Reducing Alcohol Involved Sexual violence in higher Education (RAISE)" is a longitudinal study that builds on a previous cluster-randomized controlled trial on college campuses in Pennsylvania and West Virginia (R01 AA023260). The study aims to reach students at elevated risk for SV and hazardous drinking: students with history of SV, students who identify as sexual/gender minority, and students who have disabilities (65% of our previous sample). SV, particularly alcohol-involved SV, remains highly prevalent on college campuses. A previous study by this research team found that a large proportion of students seeking care in CHCs have experienced SV victimization (n=2291, 64% of women, 32% of men re-port lifetime SV) which is associated with binge drinking. Students identifying as sexual or gender minority or endorsing a disability (i.e., physical, emotional, sensory, neurologic, and learning impairments) report particularly high lifetime prevalence of SV that is associated with greater odds of binge drinking compared to students not exposed to SV. The previous RCT involved training CHC staff to deliver a brief educational intervention to re-duce SV risk, titled "Giving Information for Trauma Support and Safety" (GIFTSS), to all students seeking care. Implementation varied across CHCs. Among students who received GIFTSS as intended, the study found significant increases in self-efficacy to use harm reduction strategies and SV-related services. Students with history of SV had greater than four-fold increase in odds of disclosing this history to providers. The study identified provider-, clinic-and campus-level changes needed to improve intervention delivery. To more directly target use of harm reduction strategies among students at elevated risk for SV and hazardous drinking, this current study will also integrate a safety decision aid (myPlan app for use on smartphone or computer) which increases harm reduction behaviors among college women experiencing partner violence. The focus of this renewal is to 1) test strategies to improve implementation of GIFTSS, 2) offer support for students at elevated risk for SV and hazardous drinking with tailored harm reduction strategies delivered via the myPlan app after the clinic visit, and 3) strengthen campus policies to promote access to SV services and reduce hazardous drinking. A 2x2 cluster randomized controlled trial will compare two implementation strategies for GIFTSS in CHCs (provider scripts vs. learning collaborative) focusing on undergraduate students ages 18-24 (N= 2400 across 28 campuses) with follow-up at 4 months and 12 months (Aim 1). The trial will also assess effectiveness of myPlan in increasing uptake of tailored harm reduction strategies for those at elevated risk for SV and hazardous drinking (Aim 2). Finally, the study will examine alcohol and SV policy changes on each campus that may increase access to and uptake of confidential services among students at elevated risk for hazardous drinking and SV (Aim 3).

注册库
clinicaltrials.gov
开始日期
2023年6月12日
结束日期
2027年5月1日
最后更新
23天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Elizabeth Miller

Director, Adolescent and Young Adult Medicine

University of Pittsburgh

入排标准

入选标准

  • undergraduate student enrolled at participating college campus
  • age 18-24 years
  • seeking care at a participating campus college health or counseling center for any reason

排除标准

  • under the age of 18
  • not enrolled as an undergraduate at a participating campus
  • not seeking care at college health or counseling center

研究组 & 干预措施

GIFTSS Training Only

Training for college health center clinicians and staff in implementation of GIFTSS Training

干预措施: GIFTSS Training

GIFTSS Training and Learning Collaborative

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative to support implementation

干预措施: GIFTSS Training

GIFTSS Training and Learning Collaborative

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative to support implementation

干预措施: Learning Collaborative

GIFTSS Training and Provider Scripts

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts to support implementation

干预措施: GIFTSS Training

GIFTSS Training and Provider Scripts

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with provider scripts to support implementation

干预措施: Provider Scripts

GIFTSS Training, Learning Collaborative, and Provider Scripts

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative as well as provider scripts to support implementation

干预措施: GIFTSS Training

GIFTSS Training, Learning Collaborative, and Provider Scripts

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative as well as provider scripts to support implementation

干预措施: Learning Collaborative

GIFTSS Training, Learning Collaborative, and Provider Scripts

Training for college health center clinicians and staff in implementation of GIFTSS Training combined with learning collaborative as well as provider scripts to support implementation

干预措施: Provider Scripts

结局指标

主要结局

Receipt of educational resource card

时间窗: within 7 days after clinic visit

Participant self-report of receipt of the GIFTSS safety card during the visit (assessed in exit survey after visit)

Provider discussion

时间窗: within 7 days after clinic visit

Yes to any items about SV and alcohol-involved SV talking points covered by provider during college health center visit (assessed in exit survey after visit)

次要结局

  • Use of harm reduction strategies(4 months and 12 months)
  • Self-efficacy to enact harm reduction strategies(4 months and 12 months)
  • Self-efficacy to use confidential SV-related services(4 months and 12 months)
  • Alcohol use patterns (exploratory)(4 months and 12 months)
  • Use of SV-related services(4 months and 12 months)
  • SV victimization (exploratory)(4 months and 12 months)

研究点 (1)

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