跳至主要内容
临床试验/NCT05873413
NCT05873413招募中不适用

RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use

University of Nebraska Lincoln2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
450
试验地点
2
主要终点
Observational bystander behavior

研究概览

简要总结

The goal of this clinical trial is to compare the impact of providing participants with

  1. A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone
  2. Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol)
  3. A control condition focused on reducing stress

The main questions it aims to answer are:

  • Is Motivate-the-Bystander more effective than the attention control for increasing bystander behaviors?
  • Is Motivate-the-Bystander+Alcohol more effective than MTB alone for increasing bystander behaviors?
  • Is Motivate-the-Bystander+Alcohol more effective than Motivate-the-Bystander alone for decreasing alcohol use during bystander intervention opportunities?

Participants will:

  • Complete online measures (e.g., self-reported bystander behaviors, past bystander training, history of bystander intervention attempts, sexual experiences, drinking behaviors, and other substance use behaviors)
  • Complete either MTB, MTB+ALC, or the attention control condition online
  • Complete the virtual reality simulation in the lab
  • Complete electronic daily diary follow-up surveys about alcohol use and bystander intervention

详细描述

During young adulthood, an estimated one in five women experience sexual assault. The investigators seek to reduce this violence by motivating young adults to intervene with their peers to prevent sexual assault-an approach known as bystander intervention. Current bystander training is conducted in group sessions involving education about how to recognize and intervene in response to sexual risk situations. Although successful in changing knowledge and attitudes about sexual assault prevention, evaluations of these programs have rarely focused on changing actual bystander behaviors. Further, while bystander alcohol use is common in sexual risk situations, and undermines intervention attempts, alcohol consumption by bystanders is not explicitly targeted in existing intervention training programs. To address these gaps, the investigators will conduct a RCT comparing the efficacy of: 1) the recently developed bystander intervention, Motivate-the-Bystander (MTB), 2) MTB with an MI alcohol component (MTB+ALC), and 3) an attention control condition for reducing alcohol use and increasing bystander behaviors in response to sexual risk. Bystander behaviors will be assessed observationally during a virtual reality-based house party at 2 months post intervention. Participants' bystander behaviors, alcohol use, and relevant contextual variables will be assessed with an EMA measurement design using electronic daily diaries at baseline and weekly post intervention until month 9. The investigators expect that, compared to MTB alone and the control condition, MTB+ALC will produce significantly greater reductions in overall drinking and increases in prosocial bystander behaviors in a diverse sample of 450 young adults who are heavy drinkers. If the hypotheses are confirmed, results will support use of the combined MI-based bystander-alcohol intervention as an effective means of reducing drinking and motivating bystander behaviors among those at highest risk for sexual violence.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals ages 18-25
  • Heavy drinkers (as defined by using the AUDIT)
  • English fluency
  • Community members from Lancaster and surrounding counties in Nebraska
  • Signed and dated consent form
  • Stated willingness to comply with study procedures

排除标准

  • This project does not have any pre-determined exclusion criteria beyond the need to meet inclusion criteria for the study.

研究组 & 干预措施

Attention-only control

Placebo Comparator

A Zoom-based stress reduction program in which progressive muscle relaxation and other techniques are introduced and practiced.

干预措施: Attention-only Control (Behavioral)

Motivate-the-Bystander

Active Comparator

A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for increased bystander behaviors.

干预措施: Motivate-the-Bystander (Behavioral)

Motivate-the-Bystander+Alcohol

Experimental

A Zoom-based motivational interviewing prevention program that enhances knowledge, motivation, and skills for reduced alcohol use and increased bystander behaviors.

干预措施: Motivate-the-Bystander+Alcohol (Behavioral)

结局指标

主要结局

Observational bystander behavior

时间窗: 1-week follow-up

Bystander behavior is assessed with a virtual environment called Bystander in Sexual Assault Virtual Environments (B-SAVE). Participants experience a virtual "house party" and are exposed to 10 situations in which they can intervene or not. Responses are recorded and coded for the presence and effectiveness of intervention attempts.

Alcohol use

时间窗: months 0-9

Alcohol use quantity is assessed with electronic daily diaries weekly for 9 months.

Daily self-reports of bystander behavior

时间窗: months 0-9

Bystander behavior is assessed with electronic daily diaries weekly for 9 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验