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临床试验/NCT07218159
NCT07218159Enrolling By Invitation不适用

Can an Evidence-based Sexual Assault Resistance Intervention Also Prevent Intimate Partner Violence (IPV)? A Randomized Controlled Trial Sub-Study of the Efficacy of IDEA3 for Reducing IPV in Undergraduate Women

University of Maryland, College Park10 个研究点 分布在 2 个国家目标入组 289 人开始时间: 2025年9月29日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
289
试验地点
10
主要终点
Physical and psychological intimate partner violence

研究概览

简要总结

The goal of this study is to understand if the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance program works to prevent intimate partner violence in undergraduate women. Participants who were in a prior trial by the study team (the IDEA3 parent trial) and joined in September 2024 or later will be invited to also join this study at the conclusion of the parent study. Participants in this study will fill out one additional survey. Researchers will compare intimate partner violence victimization between the control group and the intervention group.

详细描述

About 1 in 4 undergraduate women experience intimate partner violence (IPV) before graduation, and 1 in 5 women experience sexual assault (SA). IPV and SA are linked to academic or professional consequences for women who are victimized in college, including decreased class attendance, difficulty concentrating on schoolwork, withdrawing from classes, and dropping out of higher education entirely. The Enhanced Assess, Acknowledge, Act (EAAA) program is the only intervention proven to reduce the one-year incidence of campus SA in a randomized controlled trial (RCT) by 50%. A trial sub-study showed that EAAA also reduced IPV victimization by over 50%. EAAA is a theory-based 12-hour group intervention that increases women's abilities to assess a situation (cognitive appraisal to recognize empirically supported "red flags"), quickly acknowledge the potential for assault (e.g., overcoming self-doubt that one may be misreading the situation), and act to resist SA using evidence-based strategies. However, uptake of this effective in-person program has been limited by the cost and burden for college campuses to implement the program themselves. The researchers are currently testing an online adaptation of EAAA known as Internet-Delivered EAAA (IDEA3) in a Canadian-funded RCT, to evaluate a version of EAAA that will be more feasible to implement widely. An online format would lower costs and allow a central non-profit to deliver the program nationwide, with students from any campus participating via Zoom. While the trial was designed to evaluate the effect of IDEA3 on SA, the researchers will add an IPV sub-study to the trial. This sub-study will determine the efficacy of IDEA3 in reducing the one-year incidence of IPV, as compared to a consent workshop control condition, in US undergraduate women. The results of the study will provide key data that can be used to scale an evidence-based solution to this critical and timely issue.

This is an add-on sub-study to NCT06058455. Participants recruited in September 2024 and later into NCT06058455 will be invited to participate in this sub-study at their 12-month survey. Participants will be invited to fill out a survey on experiences of intimate partner violence (IPV) over the prior 12 months. This sub-study will enable us to determine the efficacy of IDEA3 in reducing the one-year incidence of IPV, as compared to a consent workshop control condition, in undergraduate women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
17 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in the IDEA3 parent study in September 2024 or later and completed the 12 month survey for the parent trial
  • Original inclusion criteria for the parent trial:
  • 1st- and 2nd-year university students at one of the 4 sites
  • female-identifying students
  • students between ages of 17-24 at the time of enrollment into the parent trial
  • able to attend one of the scheduled program groups
  • able and willing to be matched with another eligible student

排除标准

  • 未提供

结局指标

主要结局

Physical and psychological intimate partner violence

时间窗: 12 months

The Composite Abuse Scale Revised-Short Form (CASR-SF) will be used to measure IPV. The scale will be administered as written (16 items), but two questions relating to sexual IPV are removed from the scale in analysis to avoid overlap with sexual assault as an outcome. Thus, the modified CASR-SF uses 14 questions to measure physical and psychological IPV. Participants indicate the frequency with which they experienced each item, from never (0) to daily (5) and are determined to have experienced IPV based on validated cutoffs. All occurrences of IPV in all new relationships since the participants' enrollment in the main IDEA3 trial will be recorded. If a participant had multiple relationships, they will be asked to indicate in which relationship(s) the IPV had occurred.

Physical and psychological intimate partner violence

时间窗: 12 months

The Composite Abuse Scale Revised-Short Form (CASR-SF) will be used to measure IPV. The scale will be administered as written (16 items), but two questions relating to sexual IPV are removed from the scale in analysis to avoid overlap with sexual assault as an outcome. Thus, the modified CASR-SF uses 14 questions to measure physical and psychological IPV. Participants indicate the frequency with which they experienced each item, from never (0) to daily (5) and are determined to have experienced IPV based on validated cutoffs. All occurrences of IPV in all new relationships since the participants' enrollment in the main IDEA3 trial will be recorded. If a participant had multiple relationships, they will be asked to indicate in which relationship(s) the IPV had occurred.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Peitzmeier

Associate Professor of Behavioral and Community Health

University of Maryland, College Park

研究点 (10)

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