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临床试验/NCT07126613
NCT07126613进行中(未招募)不适用

Development of a Just-in-Time Adaptive Intervention to Reduce High-Intensity Drinking Among Young Adults

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Average Satisfaction with the Intervention

研究概览

简要总结

This study aims to examine the feasibility and acceptability of a mobile health intervention to reduce alcohol use and related consequences among young adults. Participants will be randomly assigned to either receive access to the mobile health intervention or receive only generic study surveys. Participants will receive text message surveys sent to their personal cellphone for 4 weeks per their assigned trial arm. All participants will receive a post-survey 30 days after their final weekly survey text.

详细描述

This study aims to determine whether a mobile health intervention to reduce alcohol use and related consequences is acceptable and feasible among young adults who engage in high-intensity drinking (HID; 8+/10+ drinks per drinking occasion for females/males, respectively). The investigators aim to recruit 40 adults between 18-25 years of age who report at least one HID episode in the past 30 days.

After providing informed consent, participants will be randomly assigned to receive the mobile health intervention or control surveys only.

Participants will attend one online study visit to enroll in the study and be assigned to their study arm. All subsequent study activities will be completed asynchronously. Participants will then receive text message prompts and/or surveys to their personal cellphone either Wednesday or Thursday through Sunday for four consecutive weeks. Participants will receive a post-test survey 30 days after their final weekly survey.

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
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
否

入选标准

  • •Age 18-25
  • •Experience at least one high-intensity drinking episode in the past 30 days
  • •Able to read and write in English
  • •Consent to receiving text messages to personal cellphone
  • •No current history of substance use treatment in the past 12 months
  • •Did not participate in the Aim 2 technical field trial of the intervention

排除标准

  • •Under 18 or over 25
  • •Did not experience at least one high-intensity drinking episode in the past 30 days
  • •Unable to read and write in English
  • •Does not consent to receive text messages to personal cellphone
  • •Current or history of substance use treatment in the past 12 months
  • •Participated in the Aim 2 technical field trial of the intervention

研究组 & 干预措施

Mobile Health Intervention

Experimental

Participants will receive access to the mobile health intervention. This includes access to an online dashboard which includes a drink counter, ability to track the number of drinks consumed over the course of the study, ability to set drinking-related goals for oneself, and alcohol-related resources. Participants in the intervention will also receive tailored messages during drinking episodes which target contextual factors to reduce alcohol use.

干预措施: Mobile Health Intervention to Reduce Alcohol Use Among Young Adults (Behavioral)

No-contact control

No Intervention

Participants will receive only morning surveys and the 30-day post-test survey.

结局指标

主要结局

Average Satisfaction with the Intervention

时间窗: Assessed 30 days after the last 4-week survey text.

Measured using the following item, "How satisfied are you with your experience using this intervention?" with a 5-point response scale ranging from Not at All Satisfied (1) to Extremely Satisfied (5). A higher score indicates higher satisfaction with the intervention

Average Engagement with the Intervention Measured by the DCBI Scale

时间窗: Assessed 30 days after the last 4-week survey text.

Engagement will be assessed via 8 items from the Digital Behavior Change Intervention (DCBI) Scale. The item stem "How strongly did you experience the following?" will be repeated for the following concepts: interest, intrigue, focus, inattention, distraction, enjoyment, annoyance, and pleasure. All items will be scored on a 7 point scale from Not at All (1) to Extremely (7) and an average composite score will be derived for each participant based on responses across the seven items. Scores range from 1-7, where a higher score indicates higher engagement with the intervention.

次要结局

  • Number of Drinks Consumed per Drinking Episode(Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).)
  • Number of Drinks Consumed per Drinking Episode(Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).)
  • Average Drinking Level per Drinking Episode(Four days per week (Thursday-Sunday) for four consecutive weeks (16 total times).)
  • Frequency Score of Alcohol-Related Consequences Measured by BYAACQ(Assessed 30 days after the last 4-week survey text.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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