Clinical trial NCT06595862: Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk
Official title: Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge Drinking
Suicidal Ideation
Keywords: alcohol
suicidal thoughts
open pilot trial
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group open pilot trial, in order to test the usability of the EA-Avatar digital intervention and feasibility of the research protocols of the EA-Avatar intervention.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability of the EA-Avatar digital intervention, defined by ratings on the System Usability Scale
timeFrame: 12 weeks
measure: Feasibility of research protocols, defined as follow-up retention
timeFrame: 12 weeks
measure: Feasibility of research protocols, defined as adherence to the ecological momentary assessment/daily diary protocol
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability of EA-Avatar as rated on participant feedback surveys
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: UMass Memorial Health - Marlborough Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial, University Campus
state: Massachusetts
Study officials:
affiliation: UMass Worcester (UMass Chan Medical School)
name: Lourah M. Kelly
role: PRINCIPAL_INVESTIGATOR
References: