Proximal Risk for Suicide in Adolescents

NCT06400810 | Recruiting

• 1 other identifier: STUDY00022262
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicide; Mental Health Issue

Keywords

adolescent; emergency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Suicidal Adolescent

he study will enroll subjects aged 13-17 years admitted with a chief complaint of acute suicidality or attempt. Patients will undergo physiologic and biometric monitoring in the hospital with a wrist-wearable device and chest wall ECG leads. They will undergo serial assessment four times daily to gather data regarding their activities, affect, and suicidality.

Device: Analog Devices Inc.

Interventions

Analog Devices Inc. DEVICE

Wearable wrist device that collects Photoplethysmography, accelerometer data among other parameters.

Also known as: Analog

Suicidal Adolescent

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All suicidal adolescents presenting with acute suicidality.

You may qualify if:

• subjects aged 13-17 years
• presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Analog Device, Inc.: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Emergencies

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Sheridan, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Sheridan, MD

CONTACT

503-494-1691; sheridda@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 6, 2024
• Study Start: June 15, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)