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Clinical Trials/NCT06595862
NCT06595862CompletedNot Applicable

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

University of Massachusetts, Worcester2 sites in 1 country10 target enrollmentStarted: January 31, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 29 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

EA-Avatar

Experimental

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.

Intervention: EA-Avatar (Behavioral)

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

  • Acceptability of EA-Avatar as rated on participant feedback surveys(12 weeks)

Investigators

Sponsor
University of Massachusetts, Worcester
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lourah Kelly

Assistant Professor

University of Massachusetts, Worcester

Study Sites (2)

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