Binge DrinkingEA-AvatarNCT06595862
Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk
A study testing EA-Avatar in people with Binge Drinking and Suicidal Ideation, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Binge Drinking, Suicidal Ideation
- What is being tested?
- EA-Avatar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2025to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-29 years old
- Past month binge drinking OR score of 6 or greater on the Alcohol Use Disorder Identification Test
- Past month active suicidal ideation per clinical chart and confirmed via self-report
- Have a personal smartphone device with internet access
- Speak, read, and understand English
Who cannot join
- Severe cognitive delay, active psychosis, or heavy intoxication that would interfere with understanding the study
- Imminent safety risk requiring a 1:1 observation
- In police custody during emergency department visit
- Unwilling or not interested in using an avatar-directed intervention in addition to their usual emergency department care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UMass Memorial Health - Marlborough Hospital
Marlborough, Massachusetts, 01752
UMass Memorial, University Campus
Worcester, Massachusetts, 05145
About this study
Official title: Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality
This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.
Read the detailed description
This study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge.
Ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department).
All ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care. Participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of usability of the avatar intervention and qualitative interviews of the intervention and research protocols.
Based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.
- Conditions
- Binge Drinking, Suicidal Ideation
- Being tested
- EA-Avatar
- Keywords
- alcohol, suicidal thoughts, open pilot trial
- Medical subject headings
- Binge Drinking, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA-AvatarBehavioural
The avatar-guided digital intervention includes monitoring of alcohol use and common triggers suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages provide reminders to access the avatar platform to learn or practice skills and provide encouragement.
| Study group | Role | What they receive |
|---|---|---|
| EA-Avatar | Experimental | The avatar-guided digital intervention includes monitoring of alcohol use and common triggers suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages provide reminders to access the avatar platform to learn or practice skills and provide encouragement. EA-Avatar is given in addition to emergency department care as usual. Receives: Behavioral: EA-Avatar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale
If any System Usability Items are less than 3.5 out of 5, those aspects of the digital intervention will be revised in the beta version.
Measured: 12 weeks
Feasibility of research protocols, defined as follow-up retention
Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments
Measured: 12 weeks
Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol
Feasibility will be supported by at least 75% of total EMA and daily diary surveys across 28 days
Measured: 12 weeks
Secondary outcomes (1)
Acceptability of EA-Avatar as rated on participant feedback surveys
Feedback on the alpha version of EA-Avatar measured via a feedback survey with items rated on a 4-point likert scale from strongly disagree to strongly agree, which assesses opinions about avatar appearance and customizations, the helpfulness of skills, and helpfulness of features of the platform
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Jan 2025
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group open pilot trial, in order to test the usability of the EA-Avatar digital intervention and feasibility of the research protocols of the EA-Avatar intervention.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lourah Kelly, University of Massachusetts, Worcester
- Investigators
- Lourah M. Kelly, Principal investigator, UMass Worcester (UMass Chan Medical School)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595862
- Sponsor's protocol ID
- 001128
- Other IDs
- R00AA029154
- Acronym
- EA-Avatar
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with per reasonable request to the PI, after the final report and data is published in a peer-reviewed scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality
- ClinicalTrials.gov ID
- NCT06595862
- Acronym / sponsor ID
- EA-Avatar / 001128
- Conditions
- Binge Drinking, Suicidal Ideation
- Keywords
- alcohol, suicidal thoughts, open pilot trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.
Detailed description
This study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge.
Ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department).
All ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care. Participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of usability of the avatar intervention and qualitative interviews of the intervention and research protocols.
Based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group open pilot trial, in order to test the usability of the EA-Avatar digital intervention and feasibility of the research protocols of the EA-Avatar intervention.
| Arm | Type | Receives |
|---|---|---|
| EA-Avatar | Experimental | Behavioral: EA-AvatarThe avatar-guided digital intervention includes monitoring of alcohol use and common triggers suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages provide reminders to access the avatar platform to learn or practice skills and provide encouragement. EA-Avatar is given in addition to emergency department care as usual. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18-29 years old
- Past month binge drinking OR score of 6 or greater on the Alcohol Use Disorder Identification Test
- Past month active suicidal ideation per clinical chart and confirmed via self-report
- Have a personal smartphone device with internet access
- Speak, read, and understand English
Key exclusion criteria (4 listed)
- Severe cognitive delay, active psychosis, or heavy intoxication that would interfere with understanding the study
- Imminent safety risk requiring a 1:1 observation
- In police custody during emergency department visit
- Unwilling or not interested in using an avatar-directed intervention in addition to their usual emergency department care
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 |
|---|---|---|
| EA-AvatarThe avatar-guided digital intervention includes monitoring of alcohol use and common triggers suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages provide reminders to access the avatar platform to learn or practice skills and provide encouragement. | Behavioural | EA-Avatar |
Primary outcome
Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale
Time frame: 12 weeks
If any System Usability Items are less than 3.5 out of 5, those aspects of the digital intervention will be revised in the beta version.
Feasibility of research protocols, defined as follow-up retention
Time frame: 12 weeks
Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments
Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol
Time frame: 12 weeks
Feasibility will be supported by at least 75% of total EMA and daily diary surveys across 28 days
1 secondary outcome
Acceptability of EA-Avatar as rated on participant feedback surveys
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with per reasonable request to the PI, after the final report and data is published in a peer-reviewed scientific journal.
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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.
Lourah M. Kelly principal investigator
UMass Worcester (UMass Chan Medical School)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA-Avatar in people with Binge Drinking and Suicidal Ideation, run by University of Massachusetts, Worcester at 2 sites 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 5 inclusion and 4 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale (time frame: 12 weeks). The study lists 3 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 3 Aug 2026.