Clinical trial NCT04213846: Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences
Official title: Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies to Reduce High-risk Alcohol Use and Consequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol; Use, Problem
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-12-30
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Intervention and assessment-only control group).
Primary purpose: PREVENTION

Brief summary: The proposed study will develop a smartphone/mobile app intervention that incorporates ecological momentary assessment (i.e., two brief surveys per day) and daily intervention messaging (2 messages per day) for three weeks to target high-risk alcohol use among young adult college students. The intervention mainly focuses on alcohol expectancies, alcohol use, and consequences and the daily associations between these and includes personalized intervention messages based on participants' own event-level expectations and experiences. Other psycho-educational alcohol-related content is also provided over the course of three week intervention. This mobile app intervention will be used in a randomized controlled trial (RCT) comparing young adult college students who receive the intervention with those who only receive assessments via the mobile app.

Detailed description: The purpose of this study is to develop and test a smartphone app that can both collect daily data and deliver a personalized intervention using participants' own event-level, real-world experiences to challenge proximal alcohol expectancies and alter the associations between alcohol expectancies and drinking and consequences. The mobile app intervention will be used in a randomized controlled trial comparing young adult college students who receive the intervention with those who only receive assessments via the mobile app. Assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 1-, 6-, and 12-months post-intervention.

The goal of the intervention is to target college students' alcohol expectancies (what they believe or expect alcohol's effects to be) and the associations between alcohol expectancies and alcohol use and related consequences. Intervention content will utilize twice daily messages, one in the morning (AM Messages) and one in the late afternoon or early evening (PM Messages). Most PM Messages draw on information collected in the daily assessments (Personalized Messages). Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with content that supplements information provided in the daily intervention messages.

Eligibility criteria: Inclusion Criteria:

* Typically drinking 2+ days/week, having at least 1 occasion of heavy episodic drinking (4+ women/5+ men) in last 2 weeks, having 4 or more negative consequences in the last month, owning a smartphone with a data package, agreeing to install the app on their phone and receive notifications.
* Student at a 2- or 4- year college where recruitment is located

Exclusion Criteria:

* None

Primary outcomes:
measure: Daily Drinking Questionnaire - Typical Number of Drinks Per Week
timeFrame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
measure: Peak Estimated Blood Alcohol Concentration (Peak eBAC)
timeFrame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
measure: Number of Heavy Episodic Drinking Days
timeFrame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
measure: Brief Young Adult Alcohol Consequences Questionnaire
timeFrame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Secondary outcomes:
measure: Alcohol Use Disorder Identification Test Total Score
timeFrame: Baseline and 12-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Christine M Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: