跳至主要内容
临床试验/NCT03503396
NCT03503396已完成不适用

Risk for Alcohol Impaired Driving: From the Laboratory to the Natural Environment

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Alcohol Impaired Driving Behavior

研究概览

简要总结

This is a pilot study to set up a larger investigation examining predictors of the decision to drive after consuming alcohol. All participants will carry a study provided smartphone and breathalyzer device for the 2 week period of the study. The intervention is that participants are randomly assigned to one of 2 breathalyzer feedback conditions - one where they receive a warning that their results indicate they should not drive and one where they receive no feedback. The study is designed to provide information needed for a larger version with a similar protocol, but also to provide an initial test of project hypotheses as well.

详细描述

Despite previous success in reducing alcohol impaired driving (AID) and fatal crashes, rates have not decreased significantly since the 1990s. Developing novel approaches to prevention/intervention are likely required to produce further progress.

This project is designed to evaluate a potential intervention for AID using mobile technology. In addition, the project is designed to provide pilot data for a large scale investigation.

Recent laboratory work by the PI has demonstrated the utility of assessing AID risk factors when participants are intoxicated. We identified four risk factors that, measured under intoxication, are cross-sectional predictors of AID: AID attitudes (Morris et al., 2014), impulsivity (McCarthy et al., 2012), behavioral economic demand (Amlung et al., 2016) and subjective intoxication (Amlung et al., 2014).

The proposed project will evaluate these factors as prospective predictors of AID and extend this work outside the laboratory and into participants' natural drinking environment using Ambulatory Assessment (AA). AA is a set of techniques used to collect data from individuals in the course of their daily life. AA methods provide increased ecological validity across multiple modalities (e.g., self-report, physiological measures). No study to date has used AA to examine AID. We will employ a combination of three AA methods: ecological momentary assessment, geospatial technology, and portable breath analysis.

Ecological Momentary Assessment (EMA) is a form of AA that allows participants to self-report on their current thoughts, feelings, and behaviors in their natural environment (Shiffman et al., 2008). EMA avoids most pitfalls of retrospective reports, and is increasingly used to study temporally proximal influences on substance use behaviors (Shiffman, 2009). Despite the importance of such influences to AID decisions (Quinn & Fromme, 2012), no study to date has applied EMA methods to the study of AID.

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 (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • moderate to heavy drinkers.
  • must drive regularly (including driving for social events).
  • report binge drinking (4/5 drinks in a 2 hour period) at least once in the past month
  • fluent in english

排除标准

  • no exclusion criteria other than failure to meet inclusion criteria

结局指标

主要结局

Alcohol Impaired Driving Behavior

时间窗: Baseline (4 week prior to initial interview) and trial period (2 weeks after initial interview)

Change in number of times driven after drinking per week from pre (4 week TLFB) to post (2 week TLFB). A Timeline Followback (TLFB) is an interview where the participant self-reports their drinking behavior including: where they were drinking, how much they drank of what over what period of time, what location they went to next, how they got there.

次要结局

  • Perceived Risk of Driving After Drinking(Self-reported current perception (i.e., "right now"))

研究者

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

Denis McCarthy

Professor

University of Missouri-Columbia

研究点 (2)

Loading locations...

相似试验