Proximal Risk for Suicide in Adolescents

Suicide Clinical Trial

Official title:

Proximal Risk for Suicide in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400810
• Other study ID #: STUDY00022262
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Oregon Health and Science University
• Contact: David Sheridan, MD
• Phone: 503-494-1691
• Email: sheridda[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention 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.

Description:

Suicide rates have exponentially increased, and it is now the 2nd leading cause of death in adolescence, accounting for over 1.2 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 proposal's 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 identification/intervention 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 relationship/signature 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 1.2 million suicidal adolescents presenting to EDs nationally.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: July 1, 2026
• Est. primary completion date: June 30, 2025
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• subjects aged 13-17 years

• presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.

Exclusion Criteria:

• acutely agitated patients per the treating physician

• adolescents who are not medically cleared from a suicide attempt

• no legally authorized representative available to provide consent

• parental report of significant developmental delay or autism diagnosis

• prisoners

• non-English speaking.

Related Conditions & MeSH terms

• Mental Health Issue
• Suicide

Intervention

Device:
• Analog Devices Inc.
Wearable wrist device that collects Photoplethysmography, accelerometer data among other parameters.

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Analog Device, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability and Suicidality	Prediction of Suicidality outcome measured by the Columbia Suicide Severity scale (higher score means more suicidal)	Four times daily up to one week
Primary	Heart rate variability and Suicidality	Prediction of Suicidality outcome measured by the High Frequency Heart Rate Variability Metric (lower score means less parasympathetic response)	Four times daily up to one week