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

Alcohol; Use, Problem Clinical Trial

— AMPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04213846
• Other study ID #: STUDY00002769
• Secondary ID: 2R01AA016979-05A
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol; Use, Problem

Intervention

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).

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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
Secondary	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)