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Completed

NCT Number: NCT04213846

Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences

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.

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Key information

Conditions

Alcohol; Use, Problem Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Mobile Alcohol Expectancy Intervention

Behavioral

Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. 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 supplemental information (e.g., personal BAC calculators, resources).

Primary outcomes

  1. Daily Drinking Questionnaire - Typical Number of Drinks Per Week

    Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up

    The count of self-reported typical number of drinks consumed per week during the past month

  2. Peak Estimated Blood Alcohol Concentration (Peak eBAC)

    Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up

    The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking

  3. Number of Heavy Episodic Drinking Days

    Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up

    Self-reported number of days of heavy episodic drinking (4+ drinks for females/5+ drinks for males) in the past two weeks

  4. Brief Young Adult Alcohol Consequences Questionnaire

    Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up

    Total sum score on the Brief Young Adult Alcohol Consequences Questionnaire based on number of self-reported alcohol-related consequences experienced in the past month (range from 0-24 consequences). Higher scores indicate reporting greater number of negative alcohol-related consequences.

Secondary outcomes

  1. Alcohol Use Disorder Identification Test Total Score

    Time frame: Baseline and 12-month follow-up

    Measure of hazardous/harmful drinking in the past year based on indicators of alcohol use disorder (Total score range: 0-40, with higher values indicating greater hazardous/harmful drinking)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies to Reduce High-risk Alcohol Use and Consequences

Acronym: AMPS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2019
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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