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临床试验/NCT06124898
NCT06124898已完成不适用

Development and Initial Testing of a Multi-Component Breath Alcohol- Focused Intervention for Young Adults

Northeastern University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年11月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Technology utilization

研究概览

简要总结

This is the first stage of a three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath alcohol concentration for young adults. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three mobile technologies to facilitate moderate drinking. In the first stage of the study, we will conduct formative research to obtain input from the study population, test initially the telehealth version of the brief counseling and psychoeducation and to develop a simple, "low tech" approach to coaching participants to use the three mobile technologies in typical drinking situations. Participation will last approximately one month.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be between the ages of 18-25
  • Be able to read English and complete study evaluations
  • At least occasional heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) over the prior 30 days
  • Frequent consumption of at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.

排除标准

  • Severe substance use disorder
  • Be psychotic or otherwise severely psychiatrically disabled
  • Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)

研究组 & 干预措施

Moderate drinking technologies with "lower tech" facilitation

Experimental

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.

干预措施: Alcohol-related mobile health technologies (Device)

Moderate drinking technologies with "lower tech" facilitation

Experimental

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.

干预措施: Motivational interview and psychoeducation on blood/breath alcohol concentration (Behavioral)

Moderate drinking technologies with "lower tech" facilitation

Experimental

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.

干预措施: Lower tech facilitation (Behavioral)

Moderate drinking technologies with "higher tech" facilitation

Experimental

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation

干预措施: Alcohol-related mobile health technologies (Device)

Moderate drinking technologies with "higher tech" facilitation

Experimental

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation

干预措施: Motivational interview and psychoeducation on blood/breath alcohol concentration (Behavioral)

Moderate drinking technologies with "higher tech" facilitation

Experimental

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation

干预措施: Higher tech facilitation (Device)

Attention control condition

Active Comparator

To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.

干预措施: Attention control psychoeducation (Behavioral)

Attention control condition

Active Comparator

To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.

干预措施: Attention control technology (Device)

结局指标

主要结局

Technology utilization

时间窗: Across the field testing period, 2-4 weeks

Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred

Usability

时间窗: At the end of the field testing period, 2-4 weeks

Score on acceptability subscale of Modified System Usability Scale

Acceptability

时间窗: At the end of the field testing period, 2-4 weeks

Score on acceptability subscale of Modified System Usability Scale

次要结局

  • Negative consquences(At the end of the field testing period, 2-4 weeks)
  • Drinks per drinking day(Across the field testing period, 2-4 weeks)
  • Estimated blood alcohol content(Across the field testing period, 2-4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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