Viewing Study NCT06400810



Ignite Creation Date: 2024-05-11 @ 8:30 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06400810
Status: RECRUITING
Last Update Posted: 2024-05-06
First Post: 2024-04-17

Brief Title: Proximal Risk for Suicide in Adolescents
Sponsor: Oregon Health and Science University
Organization: Oregon Health and Science University

Study Overview

Official Title: Proximal Risk for Suicide in Adolescents
Status: RECRUITING
Status Verified Date: 2024-05
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: The central hypothesis is that biometric data can continuously monitor and allow for early identificationintervention of escalating suicidal symptoms The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents
Detailed Description: Suicide rates have exponentially increased and it is now the 2nd leading cause of death in adolescence accounting for over 12 million annual emergency department ED visits After an ED visit or attempt up to 20 of adolescents will have a second attempt within 12 months and almost half will have a repeat ED visit This proposals overall objectives are to investigate physiologic parameters and biometric data from wearable technology that is temporally related to suicidal behavior and develop a personalized predictive tool that can improve outpatient identification of adolescent patients with suicidality before a crisis develops requiring an ED visit The central hypothesis is that biometric data can continuously monitor and allow for early identificationintervention of escalating suicidal symptoms The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents To attain the overall objectives I will pursue the following specific aims i To evaluate whether HRV combined with patient-specific risk factors can be used to detect dynamic changes in suicide severity among a prospective cohort of acutely suicidal adolescents ii To utilize machine learning to determine whether there is a temporal relationshipsignature in the raw PPG signal before or immediately after changes in suicide severity reporting combined with patient-specific risk factors to develop a prediction tool for suicidality risk These aims will be accomplished in three years through a prospective observational study enrolling acutely suicidal adolescents in the ED and an inpatient psychiatric unit Ultimately such knowledge can offer unique opportunities for early detection just-in-time interventions and support over 12 million suicidal adolescents presenting to EDs nationally

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