Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595862
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Evaluation of an Avatar-guided Mobile Health Intervention for Emerging Adults With Alcohol Misuse and Suicidality
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EA-Avatar
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None