Alcohol; Use, ProblemAMPSNCT04213846
Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences
A study testing Experimental: Mobile Alcohol Expectancy Intervention in people with Alcohol; Use, Problem, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Use, Problem
- What is being tested?
- Experimental: Mobile Alcohol Expectancy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies to Reduce High-risk Alcohol Use and Consequences
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.
Read the 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.
- Conditions
- Alcohol; Use, Problem
- Being tested
- Experimental: Mobile Alcohol Expectancy Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Mobile Alcohol Expectancy InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Experimental: Mobile Alcohol Expectancy Intervention |
| Assessment-only Control | No intervention | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Secondary outcomes (1)
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)
Measured: Baseline and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start6 Jan 2020
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol; Use, ProblemStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Intervention and assessment-only control group).
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christine Lee, University of Washington
- Investigators
- Christine M Lee, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213846
- Sponsor's protocol ID
- STUDY00002769
- Other IDs
- 2R01AA016979-05A1
- Acronym
- AMPS
- Status last verified
- Sep 2024
- First submitted
- 24 Dec 2019
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Mobile Phone App Intervention: Challenging Alcohol Expectancies to Reduce High-risk Alcohol Use and Consequences
- ClinicalTrials.gov ID
- NCT04213846
- Acronym / sponsor ID
- AMPS / STUDY00002769
- Conditions
- Alcohol; Use, Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two conditions (mobile Alcohol Expectancy Intervention and assessment-only control group).
| Arm | Type | Receives |
|---|---|---|
| Mobile Alcohol Expectancy Intervention | Experimental | Behavioral: Experimental: Mobile Alcohol Expectancy InterventionParticipants randomized to the intervention condition will receive twice daily intervention messages for three weeks and have access to other psycho-educational alcohol information. |
| Assessment-only Control | No intervention | –Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Mobile Alcohol Expectancy InterventionParticipants 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). | Behavioural | Mobile Alcohol Expectancy Intervention |
Primary outcome
Daily Drinking Questionnaire - Typical Number of Drinks Per Week
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Alcohol Use Disorder Identification Test Total Score
Time frame: Baseline and 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Lee, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Mobile Alcohol Expectancy Intervention in people with Alcohol; Use, Problem, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Drinking Questionnaire - Typical Number of Drinks Per Week (time frame: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.