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

Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol; Use, Problem
• Intervention / Treatment: Behavioral: Experimental: Mobile Alcohol Expectancy Challenge (mAEC)

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 (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.

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Alcohol Expectancy Challenge (mAEC); 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); 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).
No Intervention: Assessment-only Control; Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Christine M Lee, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 26, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: STUDY00002769; 2R01AA016979-05A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Datasets with cross-sectional and/or longitudinal datasets will be available in Microsoft Excel, where it can be transferred easily to a statistical program such as SAS, Stata, SPSS, or R. Codebooks to assist with data analyses and interpretation will be created and can be shared. We plan to make the datasets available for sharing at the time that the main project findings are published or shortly thereafter. We will share data that do not compromise individuals' rights and privacy available in accordance with the University of Washington (UW) IRB policies. To facilitate replication in other studies, all measures we use are available in the public domain and are popular measures of alcohol use, alcohol-related consequences or alcohol expectancies. For any measure we modify or create for our purposes, we will described in detail (with added items listed) these changes in our published work.

IPD Sharing Time Frame

The raw datafile and codebook, which will initially be used for internal study team purposes, will be available for public use after our main aims paper are published; approximately one year of the final year of funding.

Analytic code will be made available upon request after publication of manuscript.

• IPD Sharing Access Criteria: Individual researchers can contact the PI for data requests. Researchers can request datasets to replicate published papers and/or for new unpublished analyses unrelated to main study aims. After contacting the PI, researchers will be requested to fill out a questionnaire with respect to data requested and appropriate forms for data sharing. Requests will be reviewed by the PI and co-investigators to determine if analyses are currently underway for the same variables. If not, study documentation and de-identified data will be made available to the requestor.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No