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

Not Applicable

Recruiting

• Conditions: Binge Drinking; Suicidal Ideation
• Interventions: Behavioral: EA-Avatar

• Registration Number: NCT06595862
• Lead Sponsor: University of Massachusetts, Worcester

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.

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.

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Study Start: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Emergency department admission for alcohol- or suicide-related reason
• aged 18-29
• speak, read, and understand English
• binge drinking and alcohol use problems in the past month
• active suicidal ideation in the past month
• owning and having access to a personal smartphone

Exclusion Criteria

• severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation
• at imminent safety risk and need to be on a 1:1 observation, in which case research may interfere with their clinical care in the emergency department
• under arrest or a prisoner/inmate
• not interested or are unwilling to use an avatar-guided digital intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EA-Avatar	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.

Primary Outcome Measures

Name	Time	Method
Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale	12 weeks	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.
Feasibility of research protocols, defined as follow-up retention	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	12 weeks	Feasibility will be supported by at least 75% of total EMA and daily diary surveys across 28 days

Secondary Outcome Measures

Name	Time	Method
Acceptability of EA-Avatar as rated on participant feedback surveys	12 weeks	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

Trial Locations

Locations (2)

UMass Memorial Health - Marlborough Hospital; 🇺🇸 Marlborough, Massachusetts, United States

UMass Memorial, University Campus; 🇺🇸 Worcester, Massachusetts, United States