Alcohol; Use, Problem
Conditions
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 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.
Interventions
BEHAVIORALExperimental: 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).
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Intervention and assessment-only control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Drinking Questionnaire - Typical Number of Drinks Per Week | Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up | The count of self-reported typical number of drinks consumed per week during the past month |
| Peak Estimated Blood Alcohol Concentration (Peak eBAC) | Baseline, 1-month follow-up, 6-month follow-up, and 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 |
| Number of Heavy Episodic Drinking Days | Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up | Self-reported number of days of heavy episodic drinking (4+ drinks for females/5+ drinks for males) in the past two weeks |
| Brief Young Adult Alcohol Consequences Questionnaire | Baseline, 1-month follow-up, 6-month follow-up, and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Disorder Identification Test Total Score | Baseline and 12-month follow-up | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Assessment-only Control Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. | 203 |
| 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). | 205 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 21 |
| Overall Study | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | Assessment-only Control | Mobile Alcohol Expectancy Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants | 205 Participants | 408 Participants |
| Age, Continuous | 20.78 years STANDARD_DEVIATION 1.59 | 20.90 years STANDARD_DEVIATION 1.66 | 20.84 years STANDARD_DEVIATION 1.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 30 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 167 Participants | 169 Participants | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 37 Participants | 39 Participants | 76 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 24 Participants | 40 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 6 Participants | 18 Participants |
| Race (NIH/OMB) White | 125 Participants | 131 Participants | 256 Participants |
| Region of Enrollment United States | 203 participants | 205 participants | 408 participants |
| School Type 2-year college | 50 Participants | 52 Participants | 102 Participants |
| School Type 4-year college | 153 Participants | 153 Participants | 306 Participants |
| Sex: Female, Male Female | 129 Participants | 131 Participants | 260 Participants |
| Sex: Female, Male Male | 74 Participants | 74 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 205 |
| other Total, other adverse events | 0 / 203 | 0 / 205 |
| serious Total, serious adverse events | 0 / 203 | 0 / 205 |
Outcome results
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.
Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | Baseline | 9.14 number of consequences | Standard Deviation 3.82 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 1-month follow-up | 5.92 number of consequences | Standard Deviation 4.41 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 6-month follow-up | 5.95 number of consequences | Standard Deviation 4.93 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 12-month follow-up | 5.97 number of consequences | Standard Deviation 4.58 |
| Mobile Alcohol Expectancy Intervention | Brief Young Adult Alcohol Consequences Questionnaire | 12-month follow-up | 5.89 number of consequences | Standard Deviation 4.78 |
| Mobile Alcohol Expectancy Intervention | Brief Young Adult Alcohol Consequences Questionnaire | Baseline | 8.88 number of consequences | Standard Deviation 4.12 |
| Mobile Alcohol Expectancy Intervention | Brief Young Adult Alcohol Consequences Questionnaire | 6-month follow-up | 5.16 number of consequences | Standard Deviation 4.7 |
| Mobile Alcohol Expectancy Intervention | Brief Young Adult Alcohol Consequences Questionnaire | 1-month follow-up | 5.85 number of consequences | Standard Deviation 5.17 |
Comparison: Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.7895% CI: [0.82, 1.16]Generalized linear mixed model
Comparison: Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.2795% CI: [0.75, 1.08]Generalized linear mixed model
Comparison: Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.9595% CI: [0.84, 1.2]Generalized linear mixed model
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
Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | Baseline | 13.51 drinks | Standard Deviation 10.17 |
| Assessment-only Control | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | 1-month follow-up | 10.70 drinks | Standard Deviation 10.29 |
| Assessment-only Control | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | 6-month follow-up | 9.46 drinks | Standard Deviation 9.47 |
| Assessment-only Control | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | 12-month follow-up | 9.91 drinks | Standard Deviation 11.22 |
| Mobile Alcohol Expectancy Intervention | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | 12-month follow-up | 8.81 drinks | Standard Deviation 7.83 |
| Mobile Alcohol Expectancy Intervention | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | Baseline | 12.23 drinks | Standard Deviation 8.49 |
| Mobile Alcohol Expectancy Intervention | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | 6-month follow-up | 9.06 drinks | Standard Deviation 8.46 |
| Mobile Alcohol Expectancy Intervention | Daily Drinking Questionnaire - Typical Number of Drinks Per Week | 1-month follow-up | 8.95 drinks | Standard Deviation 7.76 |
Comparison: Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.3495% CI: [0.81, 1.07]Generalized linear mixed model
Comparison: Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.3795% CI: [0.91, 1.3]Generalized linear mixed model
Comparison: Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.895% CI: [0.85, 1.23]Generalized linear mixed model
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
Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Number of Heavy Episodic Drinking Days | Baseline | 2.85 Number of days | Standard Deviation 2.22 |
| Assessment-only Control | Number of Heavy Episodic Drinking Days | 1-month follow-up | 2.26 Number of days | Standard Deviation 2.32 |
| Assessment-only Control | Number of Heavy Episodic Drinking Days | 6-month follow-up | 2.07 Number of days | Standard Deviation 2.2 |
| Assessment-only Control | Number of Heavy Episodic Drinking Days | 12-month follow-up | 2.03 Number of days | Standard Deviation 2.13 |
| Mobile Alcohol Expectancy Intervention | Number of Heavy Episodic Drinking Days | 12-month follow-up | 1.83 Number of days | Standard Deviation 2.02 |
| Mobile Alcohol Expectancy Intervention | Number of Heavy Episodic Drinking Days | Baseline | 2.85 Number of days | Standard Deviation 2.13 |
| Mobile Alcohol Expectancy Intervention | Number of Heavy Episodic Drinking Days | 6-month follow-up | 2.04 Number of days | Standard Deviation 2.37 |
| Mobile Alcohol Expectancy Intervention | Number of Heavy Episodic Drinking Days | 1-month follow-up | 1.87 Number of days | Standard Deviation 1.95 |
Comparison: Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.0495% CI: [0.69, 0.99]Generalized linear mixed model
Comparison: Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.8495% CI: [0.77, 1.23]Generalized linear mixed model
Comparison: Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.3495% CI: [0.73, 1.22]Generalized linear mixed model
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
Time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | Baseline | 0.19 grams per deciliter | Standard Deviation 0.14 |
| Assessment-only Control | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | 1-month follow-up | 0.15 grams per deciliter | Standard Deviation 0.11 |
| Assessment-only Control | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | 6-month follow-up | 0.14 grams per deciliter | Standard Deviation 0.12 |
| Assessment-only Control | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | 12-month follow-up | 0.14 grams per deciliter | Standard Deviation 0.11 |
| Mobile Alcohol Expectancy Intervention | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | 12-month follow-up | 0.13 grams per deciliter | Standard Deviation 0.1 |
| Mobile Alcohol Expectancy Intervention | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | Baseline | 0.16 grams per deciliter | Standard Deviation 0.1 |
| Mobile Alcohol Expectancy Intervention | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | 6-month follow-up | 0.13 grams per deciliter | Standard Deviation 0.1 |
| Mobile Alcohol Expectancy Intervention | Peak Estimated Blood Alcohol Concentration (Peak eBAC) | 1-month follow-up | 0.14 grams per deciliter | Standard Deviation 0.11 |
Comparison: Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.7595% CI: [0.88, 1.2]Generalized linear mixed model
Comparison: Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.7295% CI: [0.86, 1.25]Generalized linear mixed model
Comparison: Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.9195% CI: [0.85, 1.21]Generalized linear mixed model
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)
Time frame: Baseline and 12-month follow-up
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Alcohol Use Disorder Identification Test Total Score | Baseline | 12.52 units on a scale | Standard Deviation 5.46 |
| Assessment-only Control | Alcohol Use Disorder Identification Test Total Score | 12-month follow-up | 10.72 units on a scale | Standard Deviation 5.68 |
| Mobile Alcohol Expectancy Intervention | Alcohol Use Disorder Identification Test Total Score | Baseline | 11.88 units on a scale | Standard Deviation 4.87 |
| Mobile Alcohol Expectancy Intervention | Alcohol Use Disorder Identification Test Total Score | 12-month follow-up | 10.04 units on a scale | Standard Deviation 5.34 |
Comparison: Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.p-value: 0.6995% CI: [0.89, 1.08]Generalized linear mixed model