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

Primary Purpose

Alcohol; Use, Problem

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Mobile Alcohol Expectancy Challenge (mAEC)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol; Use, Problem

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Alcohol Expectancy Challenge (mAEC)

Assessment-only Control

Arm Description

Participants randomized to the mAEC condition will receive twice daily intervention messages for three weeks and have access to other psycho-educational alcohol information.

Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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.
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.
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.
Alcohol Use Disorder Identification Test (AUDIT) alcohol use disorder symptoms
Total score on AUDIT based on alcohol use disorder indicators in the past year
Daily Alcohol Use
Number of standard drinks consumed yesterday
Daily Alcohol-related Consequences
Number of positive and negative alcohol-related consequences experienced yesterday

Secondary Outcome Measures

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
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

Full Information

First Posted
December 24, 2019
Last Updated
June 17, 2021
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04213846
Brief Title
Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences
Acronym
AMPS
Official Title
Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies to Reduce High-risk Alcohol Use and Consequences
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Use, Problem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Alcohol Expectancy Challenge (mAEC)
Arm Type
Experimental
Arm Description
Participants randomized to the mAEC condition will receive twice daily intervention messages for three weeks and have access to other psycho-educational alcohol information.
Arm Title
Assessment-only Control
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Mobile Alcohol Expectancy Challenge (mAEC)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Daily Drinking Questionnaire - Typical number of drinks per week
Description
The count of self-reported typical number of drinks consumed per week during the past month
Time Frame
1-month follow-up
Title
Daily Drinking Questionnaire - Typical number of drinks per week
Description
The count of self-reported typical number of drinks consumed per week during the past month
Time Frame
6-month follow-up
Title
Daily Drinking Questionnaire - Typical number of drinks per week
Description
The count of self-reported typical number of drinks consumed per week during the past month
Time Frame
12-month follow-up
Title
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
Description
The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking
Time Frame
1-month follow-up
Title
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
Description
The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking
Time Frame
6-month follow-up
Title
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
Description
The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking
Time Frame
12-month follow-up
Title
Number of heavy episodic drinking episodes
Description
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month
Time Frame
1-month follow-up
Title
Number of heavy episodic drinking episodes
Description
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month
Time Frame
6-month follow-up
Title
Number of heavy episodic drinking episodes
Description
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males) during the past month
Time Frame
12-month follow-up
Title
Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)
Description
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.
Time Frame
1-month follow-up
Title
Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)
Description
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.
Time Frame
6-month follow-up
Title
Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)
Description
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.
Time Frame
12-month follow-up
Title
Alcohol Use Disorder Identification Test (AUDIT) alcohol use disorder symptoms
Description
Total score on AUDIT based on alcohol use disorder indicators in the past year
Time Frame
12-month follow-up
Title
Daily Alcohol Use
Description
Number of standard drinks consumed yesterday
Time Frame
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)
Title
Daily Alcohol-related Consequences
Description
Number of positive and negative alcohol-related consequences experienced yesterday
Time Frame
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 Measure Information:
Title
Brief Comprehensive Effects Of Alcohol (Brief CEOA)
Description
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
Time Frame
1-month
Title
Daily Positive and Negative Alcohol Expectancies
Description
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
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Lee, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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