Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk
EA-Avatar
Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality
2 other identifiers
interventional
10
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
January 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
February 20, 2026
February 1, 2026
1.3 years
September 11, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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
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
12 weeks
Secondary Outcomes (1)
Acceptability of EA-Avatar as rated on participant feedback surveys
12 weeks
Study Arms (1)
EA-Avatar
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UMass Memorial Health - Marlborough Hospital
Marlborough, Massachusetts, 01752, United States
UMass Memorial, University Campus
Worcester, Massachusetts, 05145, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lourah M. Kelly
UMass Worcester (UMass Chan Medical School)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 11, 2024
First Posted
September 19, 2024
Study Start
January 31, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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.
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.