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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01AA016979-05A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Alcohol Expectancy Intervention | Experimental | Participants randomized to the intervention condition will receive twice daily intervention messages for three weeks and have access to other psycho-educational alcohol information. |
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| Assessment-only Control | No Intervention | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Mobile Alcohol Expectancy Intervention | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Disorder Identification Test Total Score | Measure of hazardous/harmful drinking in the past year based on indicators of alcohol use disorder (Total score range: 0-40, with higher values indicating greater hazardous/harmful drinking) | Baseline and 12-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine M Lee, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
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.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Assessment-only Control | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
| FG001 | Mobile Alcohol Expectancy Intervention | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Assessment-only Control | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
| BG001 | Mobile Alcohol Expectancy Intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | drinks | Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up |
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Adverse event data were collected between initial screening and final follow-up for each participant, a period of up to fifteen months.
We used clinicaltrials.gov definitions for adverse events and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assessment-only Control | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Lee, Ph.D. | University of Washington | 206-543-6574 | leecm@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2024 | May 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2024 | May 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Intervention and assessment-only control group).
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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).
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| School Type | Count of Participants | Participants |
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| 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 | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | grams per deciliter | Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up |
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| Primary | 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 | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Number of days | Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up |
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| Primary | 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. | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | number of consequences | Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up |
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| Secondary | Alcohol Use Disorder Identification Test Total Score | Measure of hazardous/harmful drinking in the past year based on indicators of alcohol use disorder (Total score range: 0-40, with higher values indicating greater hazardous/harmful drinking) | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-month follow-up |
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| 0 |
| 203 |
| 0 |
| 203 |
| 0 |
| 203 |
| EG001 | Mobile Alcohol Expectancy Intervention | 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). | 0 | 205 | 0 | 205 | 0 | 205 |
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| 1-month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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| Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section. | Generalized linear mixed model | Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer. | 0.72 | Count/Rate Ratio | 1.04 | 2-Sided | 95 | 0.86 | 1.25 | Superiority | Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up. |
| Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section. | Generalized linear mixed model | Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer. | 0.91 | Count/Rate Ratio | 1.01 | 2-Sided | 95 | 0.85 | 1.21 | Superiority | Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up. |
| 1-month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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| Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section. | Generalized linear mixed model | Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution. | 0.84 | Count/Rate Ratio | 0.98 | 2-Sided | 95 | 0.77 | 1.23 | Superiority | Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up. |
| Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section. | Generalized linear mixed model | Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution. | 0.34 | Count/Rate Ratio | 0.90 | 2-Sided | 95 | 0.73 | 1.22 | Superiority | Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up. |
| 1-month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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| Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section. | Generalized linear mixed model | Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution. | 0.27 | Count/Rate Ratio | 0.90 | 2-Sided | 95 | 0.75 | 1.08 | Superiority | Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up. |
| Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section. | Generalized linear mixed model | Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution. | 0.95 | Count/Rate Ratio | 1.01 | 2-Sided | 95 | 0.84 | 1.20 | Superiority | Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up. |
| 12-month follow-up |
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