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临床试验/NCT05773027
NCT05773027已完成不适用

Integrated Alcohol and Sexual Assault Intervention for College Men

Lifespan2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2013年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Lifespan
入组人数
115
试验地点
2
主要终点
Alcohol use, heavy drinking quantity

研究概览

简要总结

This research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Specifically, this study will conduct a randomized controlled pilot trial with college men who report heavy drinking to demonstrate the feasibility and acceptability of the proposed intervention. The main questions the study will answer are: 1) what is the feasibility of the recruitment plans, research design, intervention training methods, and delivery of the program?; and 2) does the intervention, relative to a mindfulness-based control condition, produce reductions in the quantity and frequency of alcohol use, perpetration of sexual aggression, and attitudes associated with sexual aggression over the 2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following the program. The intervention is compared to the mindfulness-based control group.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 22 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Engaging in binge drinking, defined as 5 or more drinks per day for men on the same occasion by the Substance Abuse and Mental Health Services Administration on two or more occasions in the past month.
  • Engaging in oral, vaginal, or anal sexual intercourse with a female partner one or more times in the past four months

排除标准

  • Displaying symptoms consistent with alcohol use withdrawal
  • Reporting current suicidal or homicidal ideation
  • Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder

结局指标

主要结局

Alcohol use, heavy drinking quantity

时间窗: Change from baseline alcohol use at 6 months.

Number of heavy drinking days in the past month (Minimum = 0, Maximum = 31), assessed via the timeline follow-back. Greater scores mean worse outcomes.

Sexual aggression perpetration

时间窗: Change in severity and frequency in comparison to control at 6-months.

Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.

Alcohol use, drinks per week

时间窗: Change from baseline alcohol use at 6 months.

The average number of drinks per week (Minimum = 0, Maximum = unspecified), assessed via the timeline follow-back. Greater scores mean worse outcomes.

次要结局

  • Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion(Change in perceived peer engagement in comparison to control at 6-months.)
  • Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression(Change in peer comfort with sexual aggression relative to control at 6-months.)
  • Attitudes relating to sexual aggression: Rape myth acceptance(Change in rape myth acceptance relative to control at 6-months.)
  • Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention(Change in perceived peer bystander intervention in comparison to control at 6-months.)
  • Attitudes relating to sexual aggression: Labeling of consent(Change in labeling of consent relative to control at 6-months.)
  • Protective behavioral strategies(Change in protective behavioral strategy use in comparison to control at 6-months.)
  • Bystander intervention intention to help strangers(Change in intention to help strangers relative to control at 6-months.)
  • Bystander intervention intention to help friends(Change in intent to help friends relative to control at 6-months.)
  • Perceived peer drinking norms(Change in perceived peer norms relative to control at 6-months.)
  • Attitudes relating to sexual aggression: Hyper gender ideology(Change in hyper gender ideology and increases relative to control at 6-months.)
  • Bystander intervention attitudes(Change in bystander attitudes relative to control at 6-months.)

研究者

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

Lindsay Orchowski Ph.D.

Associate Professor (Research)

Lifespan

研究点 (2)

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