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临床试验/NCT07433270
NCT07433270招募中不适用

Friend-based Intervention to Reduce Alcohol-Involved Sexual Assault Risk

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2026年5月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
560
试验地点
1
主要终点
Alcohol-Involved Sexual Assault

研究概览

简要总结

This Phase 2 trial will to examine the efficacy of a brief dyad-based motivational interview (PAIRS MI) delivered to friend dyads with an active treatment-as-usual condition, and a 1-year follow-up.

详细描述

In this project the investigators will conduct a Phase 2 trial to test the efficacy of a friend-based motivational interview (FMI) compared to a treatment-as-usual (TAU) control, following participants over 1-year post-intervention (Aim 1.). With this trial the investigators also will address some key questions about FMI effects on target attitudes and behaviors (Aim 2.a.) that may be mechanisms of intervention outcome (Aim 2.b.). This includes Instrumental mechanisms (readiness, barriers, and assault protective behavior skills), and the dyadic relationship (closeness, collaboration between the friends in the dyad).

Aim 1. In a Phase 2 trial, the investigators will examine the efficacy of a friend-based motivational intervention (FMI) to reduce AISA risk relative to an active control condition over 1-year post-intervention.

The investigators will compare the FMI to a standard sexual assault prevention intervention widely used on U.S. college campuses. The investigators will use a three-level HLM, with repeated measures over one year (3, 6, 9, 12-month follow-up) nested within person (Level 2), and person nested within dyad (Level 3) to examine AISA outcomes. The investigators expect those in the FMI to report fewer incidences of AISA at follow-up assessments. Both AISA and assaults not involving alcohol will be examined.

Aim 2. Examine mechanisms (instrumental, relationship) of intervention effects. In this dyad-based FMI, an interdependent process may unfold that influences outcomes whereby the FMI influences AISA risk through a person's own change, as well as through their friend's change. It is important to distinguish these two processes as each may be an important part of intervention effects. Accordingly, with longitudinal Actor-Partner Interdependence Models (APIM, Cook & Kenny, 2005; Kenny & Ledermann, 2017) the investigators will test whether the intervention impacts mechanisms of change through actor (a person's own change), partner (friend's change) effects, or both (Aims 2a-2c).

Aim 2.a. Examine intervention effects on instrumental and relationships putative mediators, whether the putative predictors predict AISA.

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
18 Years 至 24 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 4 or more drinks in a single sitting 2 or more times monthly in the past 3 months
  • does not live at home with parents
  • reports going out (not necessarily drinking) with the other member of their dyad > 1/week

排除标准

  • Can not speak and understand English sufficiently

研究组 & 干预措施

FMI

Experimental

干预措施: Friend-Based Motivational Interview (Behavioral)

treatment-as-usual

Active Comparator

干预措施: Treatment as usual (TAU) (Behavioral)

结局指标

主要结局

Alcohol-Involved Sexual Assault

时间窗: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up

Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior 2 weeks. Each item will be coded 1 (yes) or 0 (no), based on whether it happened to the woman/friend on each occasion that the pair socialized together.

Change in Drinking

时间窗: This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up

Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption. Higher scores indicate greater alcohol consumption.

次要结局

  • Change in Readiness to Intervene(This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up)
  • Change in Peer-Directed Bystander Behaviors Scale for Strangers(This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up)
  • Changes to Assault Protective Strategies(This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up)
  • Change to Barriers to Sexual Assault Bystander Intervention(This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up)
  • Change to Concerns About Intervening(This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up)
  • Change to Bystander Intervention Behavior(This will be completed during Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 9 month follow-up, and 12 month follow-up)

研究者

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

Jennifer Read

SUNY Distinguished Professor and Chair of Department of Psychology

State University of New York at Buffalo

研究点 (1)

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