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临床试验/NCT05738837
NCT05738837已完成不适用

A Phase III Randomized Wait-list Controlled Trial of the Efficacy of the Adolescent Adaptation of the EAAA Sexual Assault Resistance Education Program

University of Windsor1 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2023年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
343
试验地点
1
主要终点
Completed Rape

研究概览

简要总结

Sexual violence (SV) perpetrated by dating partners and male acquaintances is common among adolescent girls in high school. Girls and young women who experience SV are likely to encounter negative mental and physical health consequences as well as lowered academic performance. While educational interventions to address the problem of SV are numerous, when evaluated, few show any capacity to reduce sexual violence victimization or perpetration. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program for female university students (ages 17-24) is a rare exception; in a rigorous trial, EAAA reduced attempted and completed rape by 50% in the following year. The current randomized controlled trial (RCT) will test whether a version of EAAA that has been adapted for younger girls (age 14-18) who have not graduated high school (called the Adolescent Enhanced Assess, Acknowledge, Act [A-EAAA]) will result in similar benefits within a 6-month follow-up. The current RCT will be conducted across three sites in Ontario, Canada.

详细描述

Sexual violence (SV), which occurs along a continuum from unwanted sexual contact to rape, is common among adolescent girls and young women: research suggests 1 in 7 teen girls experiences SV. Perpetrators of SV are overwhelmingly male; however, the programs that exist to address boys'/men's perpetration are not sufficiently effective nor are they widely available. Other approaches to sexual assault prevention for adolescents, such as bystander programs, have not been shown to reduce sexual violence victimization or perpetration. Given the numerous negative consequences associated with SV, developing effective SV prevention and resistance programs targeting teens is critical for reducing victimization and improving health outcomes for adolescent girls. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program has been shown to substantially reduce rates of SV (50% for rape and attempted rape) in young women attending university (ages 17-24), but since it was designed for university students in a different developmental stage, an evidence-based adaptation was necessary. The purpose of the current study is to test the efficacy of the newly adapted Adolescent Enhanced Assess, Acknowledge, Act (A-EAAA) program in reducing sexual violence victimization among adolescent girls within 6-months of trial entry. We will continue to follow participants for one-year to evaluate whether changes in tertiary outcomes (e.g., mediators) are maintained to 12-months. A-EAAA is a 12-hour psychoeducational intervention that provides information, skills, and practice aimed at a) decreasing the time needed for girls to assess sexually coercive situations as dangerous and to take action, b) reducing emotional obstacles to taking action, c) increasing the use of the most effective methods of verbal and physical self-defense, and d) identifying sexual and relationship values and boundaries and reinforcing the right to defend them.

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

盲法说明

All participants are blind to allocation at baseline assessment. Randomization occurs after in-person survey completion and is initially masked (using colour coded room assignments). Allocation is revealed to participants by intervention staff once they arrive at their assigned intervention room. All data analysis is done by a Co-I who has no contact with participants.

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identified girls aged 14 to 18 years;
  • have not graduated high school;
  • competence in spoken and written English;
  • provide informed consent;
  • able to attend one of the scheduled programs in the data collection period in which they are enrolled.

排除标准

  • 未提供

研究组 & 干预措施

A-EAAA (Adolescent Enhanced Assess, Acknowledge, Act) immediately

Experimental

Adolescent adaptation of EAAA sexual assault resistance education (4, 3-hr sessions) begun immediately after baseline randomization

干预措施: A-EAAA Sexual Assault Resistance Education Program immediately (Behavioral)

Waitlist Control

Active Comparator

Usual care 30-min session (brief presentation on consent/sexual assault; access to local resource pamphlets) immediately after baseline randomization; A-EAAA (4, 3-hr sessions) at 6-months post-randomization

干预措施: Usual care + A-EAAA at 6 months (Behavioral)

结局指标

主要结局

Completed Rape

时间窗: Six months after randomization

The Sexual Experiences Survey Short Form Victimization (SES-SFV) will be used to measure the primary sexual assault outcomes. Completed rape will have occurred when a participant indicates she has had at least one experience of threatened, forced, or drugged completed (not attempted) sexual activity (oral, anal, or vaginal intercourse - answered 'once' or more to any of 9 questions (2c, 2d, 2e, 3c, 3d, 3e, 4c, 4d, or 4e) in the period between the baseline measurement and the 6-month survey measurement.

次要结局

  • Attempted Rape(Six months after randomization)

研究者

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

Dr. Charlene Y. Senn

Distinguished University Professor

University of Windsor

研究点 (1)

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