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

NCT ID: NCT04213846

Last Updated: 2024-09-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2022-04-29

Brief Summary

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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

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The purpose of this study is to develop and test a smartphone app that can both collect daily data and deliver a personalized intervention 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.

Conditions

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Alcohol; Use, Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Intervention and assessment-only control group).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mobile Alcohol Expectancy Intervention

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

Group Type EXPERIMENTAL

Experimental: Mobile Alcohol Expectancy Intervention

Intervention Type BEHAVIORAL

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).

Assessment-only Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: Mobile Alcohol Expectancy Intervention

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Christine Lee

Research Professor, School of Medicine: Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine M Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2R01AA016979-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002769

Identifier Type: -

Identifier Source: org_study_id

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