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

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

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Binge Alcohol Consumption
• Intervention / Treatment: Behavioral: Suicide safety planning app; Behavioral: EA-Avatar

Detailed Description

This study is a randomized controlled feasibility study with emerging adults presenting to the emergency department with alcohol misuse and suicidal ideation, to test the acceptability, feasibility, safety, and initial efficacy of a newly developed digital intervention, as well as the feasibility of research protocols.

Sixty emerging adults aged 18-29 who have received care in the emergency department for alcohol use problems and/or suicidal thoughts will be recruited and asked to complete assessments at baseline, four weeks, eight weeks, and twelve weeks, as well as twenty-eight consecutive days of daily diary surveys. Half of participants will be given access to a newly designed avatar-guided digital intervention and text message intervention for emerging adults(EA-Avatar), while half will receive a freely available suicide safety planning app. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; under guardianship; at imminent risk of harming oneself in the emergency department).

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 acceptability of the avatar intervention and qualitative interviews of the intervention and research protocols.

Primary aims include participant acceptability of the intervention as rated by satisfaction surveys and feasibility of study procedures and assessments as defined by completion of follow-up assessment and daily surveys for 28 days. Secondary aims include early signals of potential effects on alcohol use severity, binge drinking days, and suicidal ideation severity, as well as safety as defined by adverse and serious adverse events and worsening of alcohol use problems or suicidal ideation severity from baseline to 12 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Marlborough, Massachusetts, United States, 01752
      • Recruiting
      • UMass Memorial Health - Marlborough Hospital
      • Contact: Lourah M Kelly, PhD; Phone Number: 508-948-8973; Email: lourah.kelly@umassmed.edu
      • Contact: Lourah M Kelly, PhD
    • Worcester, Massachusetts, United States, 01545
      • Recruiting
      • UMass Memorial Health - University Campus
      • Contact: Lourah M Kelly, PhD; Phone Number: 508-948-8973; Email: lourah.kelly@umassmed.edu
      • Contact: Lourah M Kelly, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avatar guided digital health intervention for emerging adults (EA-Avatar); 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.	Behavioral: EA-Avatar; 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.
Active Comparator: Suicide safety plan app; Participants 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.	Behavioral: Suicide safety planning app; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, as defined by number of adverse events in each arm	Number of adverse events in each arm over 12 weeks	12 weeks
Safety, as defined by serious adverse events in each arm	Safety as defined by serious adverse events in each arm over 12 weeks	12 weeks
Safety as defined by worsening of drinking and suicidal ideation severity	Safety as defined by worsening of alcohol use problems or suicidal ideation severity from baseline to 12 weeks, in increases of the sample standard deviation in either problem	12 weeks
Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back	Decreases in days of binge drinking in the past 90 days, as reported on the Time Line Follow Back from Baseline to 12 weeks	12 weeks
Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores	Decreases in severity of suicidal ideation in the past month, as reported on the Beck Suicide Scale items 1-19, from Baseline to 12 weeks, Minimum score = 0, maximum score = 57.	12 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Lourah M Kelly, PhD, UMass Chan Medical School, Psychiatry and Behavioral Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; binge drinking; emergency department; digital health; suicidal ideation; emerging adults
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Self-Injurious Behavior; Drinking Behavior; Alcohol-Related Disorders; Suicide; Alcohol Drinking; Pathological Conditions, Signs and Symptoms; Behavior; Emergencies; Suicidal Ideation; Binge Drinking
• Other Study ID Numbers: 002997; R00AA029154 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No