Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Technology utilization
研究概览
简要总结
This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 是
入选标准
- •Be between the ages of 18-25
- •Be able to read English and complete study evaluations
- •Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days
- •Report having consumed 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.
- •Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)
- •Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale indicating at least a degree of openness to using technology to moderate drinking.
排除标准
- •No subject may:
- •Have been in inpatient or intensive outpatient treatment within the past 12 months
- •Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
- •Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.
- •History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.
- •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
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
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
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
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
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
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 (Behavioral)
Alcohol Education Condition
Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text
干预措施: Alcohol Education (Behavioral)
Alcohol Education Condition
Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text
干预措施: Alcohol Education Technology (Device)
结局指标
主要结局
Technology utilization
时间窗: 4-week field use period
Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Acceptability
时间窗: 4-week field use period
Score on acceptability subscale of Modified System Usability Scale
Usability
时间窗: 4-week field use period
Score on acceptability subscale of Modified System Usability Scale
次要结局
- Drinks per drinking day(4-week field use period)
- Estimated blood alcohol content(4-week field use period)
- Negative Consequences(4-week field use period)