跳至主要内容
临床试验/NCT05509218
NCT05509218已完成不适用

Daily Personalized Drinking Feedback Delivered Via Mobile Phone

Brown University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年8月26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
152
试验地点
1
主要终点
Drinks Per Week Post-test

研究概览

简要总结

The investigators propose to examine mornings after drinking as an optimal time to provide repeated, personalized feedback, with the goal of reducing hazardous drinking. Specifically, the investigators will further develop and pilot test a novel theory-based personalized feedback intervention (PFI) for heavy drinking young adults. Intervention strategies include personalized feedback (e.g., feedback on prior night blood alcohol concentration, consequences) contrasted with both drinking goals set at baseline and corrective normative feedback (e.g., how last night's drinking compares to peers). Up to 170 participants (50% non-college) will be randomized to one of three groups: PFI with monetary incentives for daily surveys, PFI without monetary incentives, or survey assessment only. The investigators will examine recruitment rates, retention rates, confirmation of intervention content delivery/intake, response rates to daily surveys, data quality, and ratings of intervention value. Investigators will test whether these indicators of engagement differ between those who do and do not receive monetary incentives for daily surveys. Further, baseline, post-test, and 3-month follow-up assessments will allow us to examine differences in drinking behavior between PFI and control. The results of the proposed research will result in a novel and scalable intervention for alcohol misuse among young adults, with potential to have an important impact on the public health problem of high-risk drinking.

详细描述

The investigators will recruit up to 170 participants for a small randomized controlled trial. Participants will be randomized to four weeks of intervention with or without daily incentives for completing surveys, or assessment-only control, to test feasibility, acceptability, and initial evidence of efficacy.

  1. Baseline assessment and orientation. An orientation meeting will be used to describe all study procedures and obtain informed consent. If informed consent is obtained, participants will then be given one week to complete a baseline survey (~30 minutes) on their own time, using their own computers. Data needed to personalize the intervention content will be collected during the baseline survey. Participants will be asked to choose from a range of possible goal types (e.g., max drinks per drinking event, drinks per week, weekly frequency of drinking, "skip goals", "delay goals", slow goals", "stop goals"). These goals an be integrated/contrasted with subsequent self-reported behavior on morning reports during the intervention period. After the baseline survey, a research assistant (RA) will review study procedures.
  2. Randomization. Randomization will occur following consent. The pilot randomized controlled trial (RCT) will include three conditions (mobile PFI with daily incentive for surveys, mobile PFI without daily incentives, assessment-only). PFI participants (both groups) will also complete (1) orientation and participant training (as described above), (2) four weeks of daily assessment and (3) intervention (as described below), and (4) follow-up surveys.
  3. Daily assessment. Daily assessment + feedback will begin on a Monday for all participants. A link to a web-based morning survey will be sent at 7am, and it will remain available until 2pm. When prior night alcohol use is endorsed, details will be assessed via single item measures about the drinking event.
  4. Personalized Feedback Reports. Following each daily survey on which a participant (in PFI groups) indicates prior day drinking, personalized feedback will be provided on how their most recent behavior (e.g., drinks last night, drinking days so far this week) compare/contrast with personal goals. Participants will then choose whether to receive additional feedback in any of 7 areas: blood alcohol concentration, high risk behaviors, consequences of drinking, caloric intake, spending, how drinking compares to peers, and safe drinking strategies. In addition to day-level feedback, an aggregate feedback report on drinking patterns and related behaviors will be delivered twice, once at the end of each 2-week period. At the end of the 2-week feedback report, participants in the intervention groups will have the opportunity to update/add goals for the next 2 weeks, given what they learned thus far about their personalized behavior-outcome links.
  5. Follow-up surveys. At the end of four weeks, participants in all three groups will complete a 30-minute online survey (post-intervention). The final 30-minute follow-up will take place three months after the end of intervention (four months after baseline) and will assess primary outcomes and mechanisms.

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 29 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-29 years
  • •Own a smartphone and use it daily
  • •Heavy episodic drinking (4+/5+ drinks for women/men) at least weekly in past month
  • •At least one of 10 negative consequences assessed
  • •at least somewhat willing to consider drinking even a little less than current

排除标准

  • •current participation in treatment for an alcohol or other substance use disorder
  • •participation in an earlier phase of the study
  • •enrollment in ongoing alcohol studies at the same university

研究组 & 干预措施

Personalized feedback plus incentive

Experimental

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will receive $1 per day for submitting their daily survey.

干预措施: Mobile-delivered personalized feedback (Behavioral)

Personalized feedback without incentive

Experimental

Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will NOT receive $1 per day for submitting their daily survey.

干预措施: Mobile-delivered personalized feedback (Behavioral)

Control

No Intervention

Participants in this arm will only complete baseline and follow-up surveys.

结局指标

主要结局

Drinks Per Week Post-test

时间窗: post-test (1 month following baseline; end of intervention period for those in intervention groups)

drinks per week in the past 30 days

Heavy Drinking Frequency Post-test

时间窗: post-test (end of 4-week intervention for those in intervention groups, and 1 month after baseline)

Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days

Negative Alcohol Consequences Post-test

时间窗: post-test (end of 4-week intervention)

Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

Drinks Per Week 3-month Follow-up

时间窗: 3 month follow-up (4 months following baseline)

drinks per week in the past 30 days

Heavy Drinking Frequency 3-month Follow-up

时间窗: 3 month follow-up (4 months post-baseline)

Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days

Negative Alcohol Consequences 3-month Follow-up

时间窗: 3-month follow-up (3 months after end of intervention; 4 months after baseline

Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验