ClinicalTrials.gg
CompletedNCT06595862EA-AvatarUpdated Aug 3, 2026

Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk

An interventional study of EA-Avatar in Binge Drinking and Suicidal Ideation, sponsored by University of Massachusetts, Worcester. Completed at 2 sites in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 29 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Binge Drinking
  • Suicidal Ideation

Keywords

  • alcohol
  • suicidal thoughts
  • open pilot trial
03

In context

Binge Drinking

71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.

This study's enrollment of 10 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.

Browse Binge Drinking studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    EA-Avatar

    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.

    Behavioral: EA-Avatar

Interventions

  • BehavioralEA-Avatar

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

  3. 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

    Time frame: 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

    Time frame: 12 weeks

07

Study locations

2 sites
  • UMass Memorial Health - Marlborough Hospital
    Marlborough, Massachusetts 01752, United States
  • UMass Memorial, University Campus
    Worcester, Massachusetts 05145, United States
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form

Time frame: 6 months after the last participant completes the study (completes their 12 week follow-up), data will be analyzed and submitted for publication in a peer-reviewed scientific journal.

Access criteria: After publication of main and secondary outcomes in a peer-reviewed journal, de-identified data will be available upon reasonable request to the PI.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06595862
Responsible party
Lourah Kelly (Assistant Professor, University of Massachusetts, Worcester) — Principal investigator
First posted
Sep 19, 2024
Start date
Jan 31, 2025
Primary completion
May 21, 2026
Completion
May 21, 2026
Last update
Aug 3, 2026

Study contacts

Lourah M. Kelly
principal investigator · UMass Worcester (UMass Chan Medical School)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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