Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920252
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-06-16
Brief Title:
A Digitally Assisted Risk Reduction Platform for Youth At High Risk for Suicide
Sponsor:
Ksana Health
Organization:
Ksana Health
Study Overview
Official Title:
Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth At High Risk for Suicide
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite efforts to prevent suicide US rates are climbing and suicide is the second leading cause of death among youth Digital tools especially personal smartphones are promising avenues to address these issues and can be used to provide a unique understanding of risk factors including psychological distress anhedonia and behavioral withdrawal and sleep disturbance among high-risk individuals This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people
Detailed Description:
Suicide is the second leading cause of death among youth Digital tools especially personal smartphones are promising avenues to address these issues and can be used to provide a unique understanding of risk factors including psychological distress anhedonia and behavioral withdrawal and sleep disturbance among high-risk individuals This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people Specifically we will conduct a pragmatic randomized controlled trial RCT based at the intensive outpatient services Intensive Adolescent and Family DBT Program Columbia Doctors to test the impact of using the Vira platform for patients versus treatment as usual control TAU ie not using Vira This project will include adolescent patients n 200 aged 13-18-years-old randomized to a Vira group n 100 and b treatment as usual control group n 100 Participants will include current patients receiving treatment in the intensive outpatient program and all treatment decisions will be overseen by practitioners within the program The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes Specifically we will conduct a pragmatic randomized controlled trial RCT based at the intensive outpatient services Intensive Adolescent and Family DBT Program Columbia Doctors to test the impact of using the Vira platform for patients versus treatment as usual control TAU ie not using Vira This project will include adolescent patients n 200 aged 13-18-years-old randomized to a Vira group n 100 and b treatment as usual control group n 100 Participants will include current patients receiving treatment in the intensive outpatient program and all treatment decisions will be overseen by practitioners within the program The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AAAV0626 | OTHER | Columbia University | httpsreporternihgovquickSearchR44MH128484 |
| R44MH128484 | NIH | None | None |