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
2 other identifiers
interventional
408
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2019
CompletedFirst Posted
Study publicly available on registry
December 30, 2019
CompletedStudy Start
First participant enrolled
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2022
CompletedResults Posted
Study results publicly available
September 26, 2024
CompletedSeptember 26, 2024
September 1, 2024
2.3 years
December 24, 2019
April 4, 2024
September 20, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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
Baseline, 1-month follow-up, 6-month follow-up, and 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
Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Number of Heavy Episodic Drinking Days
Self-reported number of days of heavy episodic drinking (4+ drinks for females/5+ drinks for males) in the past two weeks
Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Brief Young Adult Alcohol Consequences Questionnaire
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.
Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Secondary Outcomes (1)
Alcohol Use Disorder Identification Test Total Score
Baseline and 12-month follow-up
Study Arms (2)
Mobile Alcohol Expectancy Intervention
EXPERIMENTALParticipants randomized to the intervention condition will receive twice daily intervention messages for three weeks and have access to other psycho-educational alcohol information.
Assessment-only Control
NO INTERVENTIONParticipants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Nearly all study data (including all outcome data) were collected during the COVID-19 pandemic, which may have impacted alcohol expectancies and alcohol use, as well as contexts of alcohol use among young adult participants. All findings are based on self-report of alcohol use.
Results Point of Contact
- Title
- Christine Lee, Ph.D.
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Christine M Lee, PhD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor, School of Medicine: Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
December 24, 2019
First Posted
December 30, 2019
Study Start
January 6, 2020
Primary Completion
April 29, 2022
Study Completion
April 29, 2022
Last Updated
September 26, 2024
Results First Posted
September 26, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- 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.
- 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.
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.