Binge Alcohol ConsumptionEA-AvatarNCT07418047
Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults
A study testing EA-Avatar and Suicide safety planning app in people with Binge Alcohol Consumption and Suicidal Ideation, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Binge Alcohol Consumption, Suicidal Ideation
- What is being tested?
- EA-Avatar and Suicide safety planning app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- (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
Who cannot join
- (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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UMass Memorial Health - Marlborough Hospital
Marlborough, Massachusetts, 01752
Lourah M Kelly, PhD, 508-948-8973, lourah.kelly@umassmed.edu
Lourah M Kelly, PhD
- Recruiting
UMass Memorial Health - University Campus
Worcester, Massachusetts, 01545
Lourah M Kelly, PhD, 508-948-8973, lourah.kelly@umassmed.edu
Lourah M Kelly, PhD
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Binge Alcohol Consumption, Suicidal Ideation
- Being tested
- EA-Avatar, Suicide safety planning app
- Keywords
- suicidal ideation, binge drinking, emerging adults, feasibility, emergency department, digital health
- Medical subject headings
- Binge Drinking, Suicidal Ideation, Emergencies
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 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 planning appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Avatar guided digital health intervention for emerging adults (EA-Avatar) | Experimental | 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. Receives: Behavioral: EA-Avatar |
| Suicide safety plan app | Active comparator | 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. Receives: Behavioral: Suicide safety planning app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 daily diary surveys across 28 days
Measured: 28 days
Secondary outcomes (5)
Safety, as defined by number of adverse events in each arm
Number of adverse events in each arm over 12 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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 posted18 Feb 2026
- Study start10 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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, PhD, Principal investigator, UMass Chan Medical School, Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418047
- Sponsor's protocol ID
- 002997
- Other IDs
- R00AA029154
- Acronym
- EA-Avatar
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2026
- 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. Data will also be submitted to the National Data Archive.
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
- Randomized Controlled Feasibility Trial of an Avatar Guided Intervention for Young Adults Seen in the Emergency Department With Alcohol Use Problems and Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT07418047
- Acronym / sponsor ID
- EA-Avatar / 002997
- Conditions
- Binge Alcohol Consumption, Suicidal Ideation
- Keywords
- suicidal ideation, binge drinking, emerging adults, feasibility, emergency department, digital health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Feb 2026 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avatar guided digital health intervention for emerging adults (EA-Avatar) | Experimental | Behavioral: EA-AvatarThe 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 comparator | Behavioral: Suicide safety planning appParticipants 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- (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
Key exclusion criteria (5 listed)
- (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
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 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. | Behavioural | Avatar guided digital health intervention for emerging adults (EA-Avatar) |
| Suicide safety planning appA 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. | Behavioural | Suicide safety plan app |
Primary outcome
Acceptability as defined by positive ratings on the WAI-TECH-SF
Time frame: 12 weeks
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
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: 28 days
Feasibility will be supported by at least 75% of total daily diary surveys across 28 days
5 secondary outcomes
Safety, as defined by number of adverse events in each arm
Time frame: 12 weeks
Safety, as defined by serious adverse events in each arm
Time frame: 12 weeks
Safety as defined by worsening of drinking and suicidal ideation severity
Time frame: 12 weeks
Initial efficacy in binge drinking days, defined as days of binge drinking on the Time Line Follow-Back
Time frame: 12 weeks
Early efficacy in suicidal ideation severity, as defined by Beck Suicide Scale scores
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
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. Data will also be submitted to the National Data Archive.
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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.
UMass Memorial Health - Marlborough Hospital
Marlborough, United States
UMass Memorial Health - University Campus
Worcester, United States
Lourah M Kelly, PhD principal investigator
UMass Chan Medical School, Psychiatry and Behavioral Sciences
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 and Suicide safety planning app in people with Binge Alcohol Consumption 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 8 inclusion and 5 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as defined by positive ratings on the WAI-TECH-SF (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.