Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk (EA-Avatar)
Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Marlborough, Massachusetts, United States, 01752
- UMass Memorial Health - Marlborough Hospital
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Worcester, Massachusetts, United States, 05145
- UMass Memorial, University Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale
Time Frame: 12 weeks
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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.
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12 weeks
|
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Feasibility of research protocols, defined as follow-up retention
Time Frame: 12 weeks
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Feasibility will be supported by retention of research participants in at least 80% at each of the four assessments
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12 weeks
|
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Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol
Time Frame: 12 weeks
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Feasibility will be supported by at least 75% of total EMA and daily diary surveys across 28 days
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of EA-Avatar as rated on participant feedback surveys
Time Frame: 12 weeks
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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
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12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lourah M. Kelly, UMass Worcester (UMass Chan Medical School)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001128
- R00AA029154 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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