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

Sponsor
University of Washington (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04213846
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
408
1
2
29.8
13.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Experimental: Mobile Alcohol Expectancy Challenge (mAEC)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Challenge and assessment-only control group).Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Challenge and assessment-only control group).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies to Reduce High-risk Alcohol Use and Consequences
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Daily Drinking Questionnaire - Typical number of drinks per week [1-month follow-up]

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

  2. Daily Drinking Questionnaire - Typical number of drinks per week [6-month follow-up]

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

  3. Daily Drinking Questionnaire - Typical number of drinks per week [12-month follow-up]

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

  4. Peak Estimated Blood Alcohol Concentration (Peak eBAC) [1-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

  5. Peak Estimated Blood Alcohol Concentration (Peak eBAC) [6-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

  6. Peak Estimated Blood Alcohol Concentration (Peak eBAC) [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

  7. Number of heavy episodic drinking episodes [1-month follow-up]

    Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month

  8. Number of heavy episodic drinking episodes [6-month follow-up]

    Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month

  9. Number of heavy episodic drinking episodes [12-month follow-up]

    Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month

  10. Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) [1-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.

  11. Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) [6-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.

  12. Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) [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.

  13. Alcohol Use Disorder Identification Test (AUDIT) alcohol use disorder symptoms [12-month follow-up]

    Total score on AUDIT based on alcohol use disorder indicators in the past year

  14. Daily Alcohol Use [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)]

    Number of standard drinks consumed yesterday

  15. Daily Alcohol-related Consequences [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)]

    Number of positive and negative alcohol-related consequences experienced yesterday

Secondary Outcome Measures

  1. Brief Comprehensive Effects Of Alcohol (Brief CEOA) [1-month]

    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

  2. Daily Positive and Negative Alcohol Expectancies [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)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98105

Sponsors and Collaborators

  • University of Washington
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Christine M Lee, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine Lee, Research Professor, School of Medicine: Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier:
NCT04213846
Other Study ID Numbers:
  • STUDY00002769
  • 2R01AA016979-05A1
First Posted:
Dec 30, 2019
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2021