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临床试验/NCT03927482
NCT03927482已完成不适用

C.A.R.E.S.: A Mobile Health Program for Alcohol Risk Reduction for an Under- Served College Population

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2018年8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
239
试验地点
2
主要终点
Drinks Per Week

研究概览

简要总结

In this fast-track STTR, Phase 1 will develop and test a mobile phone app among 40 adult community college students. The app is designed to reduce risky drinking behaviors and improve user safety. In Phase 2 the app ("CARES") will be tested with 200 adult community college students who drink alcohol. Participants will be randomly assigned to the "CARES" app or an alcohol education control condition and will use the app for 12 weeks. Six month outcomes will assess changes in drinking related behaviors.

详细描述

This STTR builds on our successful pilot that developed a text message-delivered alcohol intervention for, and in collaboration with CCS. Phase I will develop and test a smart phone application (the "Cares" app) incorporating the text message program with additional features and functionality requested by students in the pilot trial (Aim 1.1). After obtaining user feedback (Aim 1.2) programming will be completed in both iOS and Android languages. To ensure that the College Alcohol Risk Education System (CARES) is well positioned to get into the community college marketplace, it is critical to demonstrate efficacy. Phase 2 will conduct an efficacy trial of CARES compared to a competing alcohol education program that would be feasible for most community colleges to adopt, thus providing a real-world comparison with data suitable to support future efforts toward commercialization. This study will also identify the types of individuals for whom CARES is more/less effective and identify how it might be improved.

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)

盲法说明

Assessors will be blind to the participant's randomization assignment

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Currently enrolled community college student
  • At least 2 heavy drinking episodes in past 2 weeks at recruitment
  • Own smart phone

排除标准

  • Alcohol abuse disorder or currently in treatment for alcohol-related problems

结局指标

主要结局

Drinks Per Week

时间窗: 30 days

Average drinks based on 30 day timeline follow back of all alcohol consumption

Alcohol Related Consequences

时间窗: 30 days

Negative life events related to drinking assessed by the Brief Young Adult Alcohol Consequences Questionnaire. Calculates a total score from 0-48, with higher numbers indicating worse outcomes.

次要结局

  • Situational Confidence(12 weeks)
  • Protective Strategies(12 weeks)

研究者

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

Beth Bock, Ph.D.

Senior Research Scientist

The Miriam Hospital

研究点 (2)

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