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Brief Alcohol E-Interventions Study

2019年6月14日 更新者:Emily Grekin、Wayne State University

Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?

The project seeks to develop an effective computer-delivered brief intervention to reduce alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of the intervention will be tested with manipulation of common factors (empathy & positive regard), use of a voice, and use of an animated narrator. Participants will include 352 undergraduate students randomly assigned to one intervention condition; follow-up assessments will take place at one and 3 months. The main outcome will be means drink per day over the past 30 day.

研究概览

详细说明

The proposed project seeks to develop a maximally effective computer-delivered brief intervention (CDBI) for reducing heavy alcohol use. To accomplish this, we will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content, beginning with factorial designs evaluating main and interaction effects of specific intervention components. Our selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of non-specific factors, such as empathy and positive regard, to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics. To accomplish these goals, we will examine outcomes of computer-delivered brief interventions in which common factors (empathy & positive regard), use of a voice, and use of an animated narrator are systematically manipulated using a factorial design. We will also systematically manipulate the presence vs. absence of motivational content in order to examine possible interactions between common factors and specific motivational techniques. Participants will be 352 undergraduates who are randomly assigned to 1 of 16 intervention conditions. Mean drinks per day over the past 30 days will be measured at 1 and 3-month follow-ups. Secondary analyses will also examine past month heavy drinking days, alcohol-related consequences, and intention to reduce alcohol use. We hypothesize that there will be significant main effects for (1) the factor consistent with Common Factors Theory (empathy and positive regard), (2) the two factors consistent with Media Equation Theory (voice and narrator), and (3) the presence of motivational content. We further hypothesize that mean drinks/day will be lower when (1) the common factors (empathy, positive regard) are combined with a voice and/or narrator or (2) motivational content is combined with common factors and/or a voice/narrator.

研究类型

介入性

注册 (实际的)

352

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Detroit、Michigan、美国、48202
        • Wayne State University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Participants must be students at Wayne State University, aged 18 or older. Additionally, participants must report either (1) consuming 3 (women)/4 (men) drinks per day or 7 (women)/14 (men) drinks per week, (2) getting drunk at least once per week over the past 6 months or (3) binge drinking at least once per week over the past 6 months (i.e. more than 4 (women)/5 (men) drinks in a 2 hr. period).

Exclusion Criteria:

Individuals who are under the age of 18, or who do not meet the study's drinking criteria

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Arm 1
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 2
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 3
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 4
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 5
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 6
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 7
7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 8
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 9
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 10
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 11
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 12
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 13
13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 14
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 15
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
实验性的:Arm 16
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.
The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean Drinks Per Day
大体时间:1 month and 3 months after baseline
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
1 month and 3 months after baseline

次要结果测量

结果测量
措施说明
大体时间
Number of Heavy Drinking Days Per Month
大体时间:1 month and 3 months after baseline
Number of days participant reports drinking 4/5 (male/female) alcoholic drinks in a 2-hour period during the past 30 days
1 month and 3 months after baseline
Report of Alcohol Related Consequences
大体时间:1 month and 3 months after baseline
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
1 month and 3 months after baseline
Intention to Reduce Alcohol Use
大体时间:1 month and 3 months after baseline
Participants self-report intentions to reduce drinking on the Drinking Intentions Questionnaire. On this questionnaire, participants rate how likely they are to reduce their drinking over the next week, month, and year on a scale ranging from '0 = Not at all likely' to '5 = Extremely likely.' Higher scores mean greater intentions to reduce drinking. In order to obtain more stable estimates and reduce type I error, responses to the week, month and year questions were summed to create a total drinking intentions score which could range from 0 to 15. More specifically, scores on each individual scale item (i.e. intentions to reduce drinking over the week, month and year) could range from 0 to 5. When summed together, these items created the total score (reported here) which could range from 0 to 15.
1 month and 3 months after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Emily Grekin, PhD、Wayne State University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月23日

初级完成 (实际的)

2017年9月25日

研究完成 (实际的)

2018年1月13日

研究注册日期

首次提交

2016年10月31日

首先提交符合 QC 标准的

2016年10月31日

首次发布 (估计)

2016年11月2日

研究记录更新

最后更新发布 (实际的)

2019年6月17日

上次提交的符合 QC 标准的更新

2019年6月14日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R21AA023660 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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