跳至主要内容
临床试验/NCT04030325
NCT04030325进行中(未招募)不适用

Motivating Campus Change Study

University of Washington2 个研究点 分布在 1 个国家目标入组 1,012 人开始时间: 2019年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,012
试验地点
2
主要终点
Change from Baseline Alcohol Use at 12 months

研究概览

简要总结

The study evaluates the relative merit of a multi-component PFI presented in the traditional simultaneous delivery (i.e., all components at once) versus a sequential format, wherein individual PFI components are delivered one at a time over several weeks to minimize time and attention demands for each component.

详细描述

This study builds upon the latest alcohol intervention literature to develop and test the next wave of personalized feedback interventions (PFIs) to address harmful alcohol use among college students. The purpose of this research is to determine optimal configuration of PFIs to take advantage of the clarity and initial impact of single-component PFIs and greater effect size and duration of personalized multi-component PFIs. The Investigators seek to increase and evaluate engagement with the PFI and text-message materials and boost innovation of both content and process of the intervention. In addition to PFI content and delivery, the investigators will use qualitative and quantitative methods to determine personal relevance of the chosen high-risk events among a sample of students who engage in heavy episodic drinking to better understand duration of PFI effects impacted by fluctuations in drinking associated with high-risk events. Prior interventions have targeted drinking in general or a single high-risk drinking event (e.g., Spring Break), but have not targeted both general and event-specific drinking together. These enhanced intervention effects, could have a significant impact on risks associated with college student drinking, and can be rapidly disseminated and implemented on campuses nationwide to address the public health problem posed by heavy episodic drinking among college students.

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
All
接受健康志愿者

入选标准

  • at least 1 heavy episodic drinking episode in the past month
  • at least 3 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past 3 months for cohort 1
  • at least 2 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past month for cohort 2 - 5
  • Indicate they own a cell phone with text message capabilities and consent to receiving text messages

排除标准

  • Doesn't meet inclusion criteria
  • Unwillingness to participate
  • Failure to provide consent
  • Plan to travel internationally in the next 12 months (for intervention text purposes)

结局指标

主要结局

Change from Baseline Alcohol Use at 12 months

时间窗: 12 months of assessment

The second primary outcome of this program of research is to assess change in alcohol use from baseline to 12 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.

Change from Baseline Alcohol Use at 18 months

时间窗: 18 months of assessment

The third primary outcome of this program of research is to assess change in alcohol use from baseline to 18 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.

Change from Baseline Alcohol Use at 6 months

时间窗: 6 months of assessment

The first primary outcome of this program of research is to assess change in alcohol use from baseline to 6 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.

Change from Baseline Alcohol Use at 24 months

时间窗: 24 months of assessment

The fourth primary outcome of this program of research is to assess change in alcohol use from baseline to 24 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.

次要结局

  • Alcohol Use on 4th of July(4 days)
  • Alcohol Use on Halloween(4 days)
  • Alcohol Use on New Years Eve(2 days)
  • Alcohol Use during Spring Break(10 days)
  • Alcohol Use during Birthday(10 days)

研究者

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

Mary Larimer

Professor, School of Medicine: Psychiatry And Behavioral Sciences

University of Washington

研究点 (2)

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