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临床试验/NCT07418424
NCT07418424Enrolling By Invitation不适用

Project SELF 2.0 Study 2 - Narrative Writing to Promote Healthy Decisions About Alcohol During the Transition Out of College

University of Washington1 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
468
试验地点
1
主要终点
Explicit drinking identity

研究概览

简要总结

The purpose of the proposed research is to evaluate (1) whether a future possible self task (FPST) can lead to changes drinking identity (DI; how much one associates one's self with drinking) and (2) whether the FPST and changes in drinking identity also change indicators of alcohol misuse . This study focuses on individuals who are graduating from college, which is a time of transition and identity change. If such changes can be demonstrated, DI may be a mechanism for alcohol misuse and the FPST may be an additional, novel intervention strategy to reduce alcohol misuse during the post-college transition.

The goal of this clinical trial is to test the future possible self task (FPST) in individuals who are about to graduate from college.

The main questions it aims to answer are:

Can the FPST change drinking identity (a risk factor for alcohol misuse)? Can the FPST reduce risks for alcohol misuse? Participants will complete the FPST, a task that involves writing for 20 minutes, and will answer a series of questionnaires and computer-based word categorization tasks. Participants will be followed for a year after completing the FPST.

Researchers will compare different versions of the FPST and different doses (one writing sessions vs. 3 writing sessions) to see which are more effective for changing drinking identity and reducing risks for alcohol misuse.

详细描述

This study will evaluate changes in drinking identity and changes in drinking during the transition out of college in a sample of 528 soon-to-graduate or recently graduated college seniors via the future possible self task (FPST). We will test whether an adapted version of the FPST can induce change in drinking identity and reduce risk of alcohol misuse. The study will have a 2 (write about future desired self in relation to drinking vs. no), x 2 (write about future feared self in relation to drinking vs. no) x 2 (write 1x only vs.1x per week for 3 weeks) design. Participants will be randomly assigned to a condition. The study will occur entirely online, with virtual baseline and intervention sessions hosted by a research assistant and with online surveys for the 1-, 3-, 6-, and 12-month follow-ups. Participants, who receive an AUDIT score of 8 or higher, and report some interest interest in changing or not increasing their drinking, will be recruited, in equal numbers, from two sites -- one at the University of Washington and one at the University of Houston. Participants will be recruited in two waves (264 each wave, with 132 from each site during each wave).

The study will test for changes in drinking identity (primary), in indicators of alcohol misuse (primary & secondary), and in associated risk factors (secondary; changes in self-efficacy, identification with future self, and craving at baseline, 1-, 3-, 6-, and 12-month follow-ups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Please note that outcomes are assessed by online survey. No person is in the role of an outcomes assessor.

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

  • Senior in college and expecting to graduate at the University of Washington or University of Houston
  • Between the ages of 18-25
  • Full time student
  • Fluent in English
  • Is willing to attend 3 weekly virtual laboratory sessions hosted on HIPAA-compliant Zoom
  • Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)
  • Scores 8 or more on the Alcohol Use Disorder Identification Test (AUDIT; cut-off for indicator of hazardous drinking) and reports drinking alcohol in the last week
  • Reports at least some interest in reducing drinking

排除标准

  • 未提供

研究组 & 干预措施

Most hoped for future self, 3 dose

Experimental

Participants complete a writing task in which they think and write about their most hoped for future self, weekly for 3 weeks (i.e., at each session).

干预措施: Most hoped for future self (Behavioral)

Most hoped future self, 1 dose

Experimental

Participants complete a writing task in which they think and write about their most hoped for future self one time (on the third session).

干预措施: Most hoped for future self (Behavioral)

Most feared future self, 3 dose

Experimental

Participants complete a writing task in which they think and write about their most feared future self, weekly for 3 weeks (i.e., at each session).

干预措施: Most feared future self (Behavioral)

Most feared future self, 1 dose

Experimental

Participants complete a writing task in which they think and write about their most feared future self one time (on the third session).

干预措施: Most feared future self (Behavioral)

Balanced self (hoped and feared self), 3 dose

Experimental

Participants complete a writing task in which they think and write about their most hoped for and feared future self, weekly for 3 weeks (i.e., at each session).

干预措施: Balanced future self (Behavioral)

Balanced self (hoped and feared self), 1 dose

Experimental

Participants complete a writing task in which they think and write about their most hoped for and feared future self one time (on the third session).

干预措施: Balanced future self (Behavioral)

Control, 3 dose

Placebo Comparator

Participants in this condition complete a task in which they think and write about a trip to the zoo weekly for 3 weeks (i.e., at each session).

干预措施: Control (trip to zoo) (Behavioral)

Control, 1 dose

Placebo Comparator

Participants in this condition complete a task in which they think and write about a trip to the zoo one time (on the third session).

干预措施: Control (trip to zoo) (Behavioral)

结局指标

主要结局

Explicit drinking identity

时间窗: Will be assessed at baseline, post-intervention, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up

This is will be evaluated by the Alcohol Self-Concept Scale. A mean score will be calculated. Scores range from -3 to +3. Higher scores indicate stronger alcohol self-concept

Implicit drinking identity

时间窗: Will be assessed at baseline, post-intervention, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up

This is will be evaluated by the Drinking Identity Implicit Association Test (IAT). A summary score, called a D score, which is similar to a Cohen's d effect size, will be calculated. Scores range from -2 to +2; higher scores indicate stronger implicit drinking identity.

Drinks per week

时间窗: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up

This is will be evaluated by the Daily Drinking Questionnaire (DDQ). It assesses drinks consumed each day of the week during a typical week during the last month. A sum of drinks over the course of the week will be calculated.

Peak drinks per month

时间窗: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up

This is will be evaluated by the Quantity/Frequency Measure (Q/F). It includes an assessment of the number of drinks consumed when one drank the most during the last month.

Typical drinks per occasion

时间窗: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up

This is will be evaluated by the Quantity/Frequency Measure (Q/F). It includes an assessment of the number of drinks consumed on a typical drinking occasion during the last month.

Alcohol-related problems

时间窗: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up

This is will be evaluated by the Brief Young Adult Alcohol Consequences Questionnaire. It assesses the consequences of drinking (happened yes or no) that occurred during the last month. A sum will be calculated. Higher scores indicate more experiencing more negative consequences from drinking. Scores range from 0 to 24

次要结局

  • Risk of Alcohol Use Disorder(Will be assessed at baseline and at 12-month follow-up)
  • Alcohol Craving - Momentary(Will be assessed at baseline and 2 weeks after baseline)
  • Alcohol Craving - Current(Will be assessed 2 weeks after baseline)
  • Alcohol Craving - Retrospective(Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)
  • Alcohol Expectancies(Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)
  • Drinking Motives(Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)
  • Social Norms(Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)
  • Identification with Future Self(Will be assessed at baseline, post-intervention, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)
  • Readiness to Change(Will be assessed at baseline, post-intervention, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)
  • Drinking Refusal Self-efficacy(Will be assessed at baseline, post-intervention, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristen Lindgren

Professor, Department of Psychiatry and Behavioral Sciences

University of Washington

研究点 (1)

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