Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults
EA-Avatar
Randomized Controlled Feasibility Trial of an Avatar Guided Intervention for Young Adults Seen in the Emergency Department With Alcohol Use Problems and Suicidal Thoughts
2 other identifiers
interventional
60
1 country
2
Brief Summary
The goal of this clinical trial is to learn whether a novel digital avatar (virtual coach) support program can help emerging adults ages 18-29 who present to the emergency department with suicidal thoughts and alcohol misuse (EA-Avatar). The study also aims to learn whether people find the program easy to use and whether daily surveys and the study design are able to be completed by the majority of emerging adult participants. The main questions this study aims to answer are:
- Do participants use the digital program and find it helpful?
- Is it possible for participants to complete daily surveys for twenty-eight days and follow-up surveys over twelve weeks?
- Are there early signs that the program may help lower alcohol use and suicidal thoughts? Researchers will compare participants who receive the new digital avatar program plus supportive text messages to participants who receive a freely available suicide safety planning app to see if there are differences in use, engagement, and early signs of benefit. Participants will:
- Receive standard care from the emergency department
- Be randomly put into one of two groups (EA-Avatar or a free suicide prevention app)
- Depending on their group, use a new avatar-guided digital support program with text message reminders OR use a free suicide safety planning app
- Complete surveys at the start of the study and again at four, eight, and twelve weeks
- Complete short daily surveys for twenty-eight days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2026
Shorter than P25 for early_phase_1
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
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
February 20, 2026
February 1, 2026
6 months
February 10, 2026
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Acceptability as defined by positive ratings on the WAI-TECH-SF
Positive ratings on the Working Alliance Inventory Technology Version, Short Form (WAI-TECH-SF) as measured by an average of 4 out of 7 or higher on the mean score. Minimum = 1, Maximum = 7, higher scores mean better acceptability
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 daily diary surveys across 28 days
28 days
Secondary Outcomes (5)
Safety, as defined by number of adverse events in each arm
12 weeks
Safety, as defined by serious adverse events in each arm
12 weeks
Safety as defined by worsening of drinking and suicidal ideation severity
12 weeks
Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back
12 weeks
Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores
12 weeks
Study Arms (2)
Avatar guided digital health intervention for emerging adults (EA-Avatar)
EXPERIMENTALThe avatar-guided digital intervention includes monitoring of alcohol use and triggers of 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 with inspirational quotes and reminders to access the avatar platform are used to support engagement and foster hope. They are also given any emergency department care and/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
Suicide safety plan app
ACTIVE COMPARATORParticipants are given information to download a freely available suicide safety planning app. They are also given any emergency department care and/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
Interventions
The avatar-guided digital intervention includes monitoring of alcohol use and triggers of 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 with inspirational quotes and reminders to access the avatar platform are used to support engagement and foster hope. They are also given any emergency department care and/or follow-up and referral services they would otherwise receive and can continue any other behavioral health care.
A publicly available suicide safety planning app which includes guidance on creating a Stanley-Brown Safety Plan, including warning signs, things users can do on their own when feeling suicidal, people who can distract them, people who can support them, professionals or organizations who can support them, and reasons for living.
Eligibility Criteria
You may qualify if:
- (1) emergency department admission for alcohol- or suicide-related reason since turning 18, OR treated for incidental suicide risk in the emergency department
- (2) aged 18-29
- (3) speak, read, and understand English
- (4) binge drinking in the past month OR alcohol use problems (Alcohol Use Disorders Identification Test score \> 5)
- (5) active suicidal ideation in the past month
- (6) owning and having access to a personal smartphone
- (7) willingness to be randomized to an avatar guided intervention for alcohol use problems and suicidal thoughts OR a freely available suicide safety planning app
- (8) for remote MyChart-based recruitment only, have MyChart activated
You may not qualify if:
- (1) severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation
- (2) imminent safety risk and have been recently unsafe to themselves or others
- (3) prisoner or are under arrest
- (4) not interested or not willing to be randomized to receive the avatar-guided digital intervention or safety plan app
- (5) under the care of a legal guardian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UMass Memorial Health - Marlborough Hospital
Marlborough, Massachusetts, 01752, United States
UMass Memorial Health - University Campus
Worcester, Massachusetts, 01545, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lourah M Kelly, PhD
UMass Chan Medical School, Psychiatry and Behavioral Sciences
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 18, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 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. Data will also be available in the National Data Archive in either October or April following study completion, whichever comes first.
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. Data will also be submitted to the National Data Archive.