Multi-Component Breath Alcohol Intervention Phase 3

Официальное название

Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3

Обзор

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.

Вмешательства

• Устройство Alcohol-related mobile health technologies
  Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.
• Поведенческое Motivational interview and psychoeducation on blood/breath alcohol concentration
  Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.
• Поведенческое Lower tech facilitation
  Study staff will review instructions for technology use closely with participants and guide them in use of existing phone technologies as reminders for use of the three moderate drinking technologies during drinking situations.
• Поведенческое Higher tech facilitation
  Participants will use an app developed during the study, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.
• Поведенческое Alcohol Education
  Brief 25/30-minute psychoeducation on generalized alcohol use providing information about alcohol and its effects, adapted from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rethinking Drinking resources
• Устройство Alcohol Education Technology
  Participants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session

Первичные конечные точки

• Technology utilization [Срок оценки: 4-week field use period]
• Acceptability [Срок оценки: 4-week field use period]
• Usability [Срок оценки: 4-week field use period]

Вторичные конечные точки (3)

• Drinks per drinking day [Срок оценки: 4-week field use period]
• Estimated blood alcohol content [Срок оценки: 4-week field use period]
• Negative Consequences [Срок оценки: 4-week field use period]

Критерии участия

• 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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Northeastern University — Boston

Идентификаторы

NCT: NCT06994962 · IRB24-12-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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