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

Study Overview
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Brief Summary
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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
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The purpose of this study is to develop and test a smartphone app that can both collect daily data and deliver a personalized intervention (mAEC) 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.

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

Conditions
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Alcohol; Use, Problem

Intervention / Treatment
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* Behavioral: Experimental: Mobile Alcohol Expectancy Challenge (mAEC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Challenge and assessment-only control group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Alcohol Expectancy Challenge (mAEC)<br>Participants randomized to the mAEC condition will receive twice daily intervention messages for three weeks and have access to other psycho-educational alcohol information. | Behavioral: Experimental: Mobile Alcohol Expectancy Challenge (mAEC)<br>* Participants randomized to the mAEC 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).<br>|
| No Intervention: Assessment-only Control<br>Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Drinking Questionnaire - Typical number of drinks per week | The count of self-reported typical number of drinks consumed per week during the past month | 1-month follow-up | 
| Daily Drinking Questionnaire - Typical number of drinks per week | The count of self-reported typical number of drinks consumed per week during the past month | 6-month follow-up | 
| Daily Drinking Questionnaire - Typical number of drinks per week | The count of self-reported typical number of drinks consumed per week during the past month | 12-month follow-up | 
| Peak Estimated Blood Alcohol Concentration (Peak eBAC) | The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking | 1-month follow-up | 
| Peak Estimated Blood Alcohol Concentration (Peak eBAC) | The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking | 6-month follow-up | 
| Peak Estimated Blood Alcohol Concentration (Peak eBAC) | The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking | 12-month follow-up | 
| Number of heavy episodic drinking episodes | Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month | 1-month follow-up | 
| Number of heavy episodic drinking episodes | Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month | 6-month follow-up | 
| Number of heavy episodic drinking episodes | Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month | 12-month follow-up | 
| Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) | 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. | 1-month follow-up | 
| Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) | 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. | 6-month follow-up | 
| Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) | 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. | 12-month follow-up | 
| Alcohol Use Disorder Identification Test (AUDIT) alcohol use disorder symptoms | Total score on AUDIT based on alcohol use disorder indicators in the past year | 12-month follow-up | 
| Daily Alcohol Use | Number of standard drinks consumed yesterday | Daily Assessment at 1-month, 6-month, and 12-month follow-up; 14 days of assessment at each time point (up to 42 days per person across the follow-up period) | 
| Daily Alcohol-related Consequences | Number of positive and negative alcohol-related consequences experienced yesterday | Daily Assessment at 1-month, 6-month, and 12-month follow-up; 14 days of assessment at each time point (up to 42 days per person across follow-up periods) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Comprehensive Effects Of Alcohol (Brief CEOA) | Mean score of Positive and Negative Alcohol Expectancies assessed with the Brief Comprehensive Effects of Alcohol Measure; Range 1-4; higher scores indicates greater expectation of likelihood of effects occurring from alcohol | 1-month | 
| Daily Positive and Negative Alcohol Expectancies | Mean score of likelihood of experiencing positive and negative alcohol experiences; Range 1-6; higher scores indicate greater expectation of positive and/or negative effects occurring that evening as a result of drinking | Daily Assessment at 1-month, 6-month, and 12-month follow-up; 14 days of assessment at each time point (up to 42 days per person across follow-up period) |