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OpenTrials
Active, Not Recruiting

NCT Number: NCT06595862

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Binge Drinking Alcohol Drinking Alcohol-Related Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Drinking Behavior Mental Disorders Self-Injurious Behavior Substance-Related Disorders Suicidal Ideation Suicide

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Health - Marlborough Hospital, Marlborough, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EA-Avatar

Behavioral

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.

Primary outcomes

  1. Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale

    Time frame: 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.

  2. 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

  3. Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol

    Time frame: 12 weeks

    Feasibility will be supported by at least 75% of total EMA and daily diary surveys across 28 days

Secondary outcomes

  1. Acceptability of EA-Avatar as rated on participant feedback surveys

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality

Acronym: EA-Avatar

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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