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Proximal Risk for Suicide in Adolescents

Proximal Risk for Suicide in Adolescents

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06400810
Enrollment
144
Registered
2024-05-06
Start date
2023-06-15
Completion date
2026-07-01
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue, Suicide

Keywords

adolescent, emergency

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.

Detailed 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.

Interventions

DEVICEAnalog Devices Inc.

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

Sponsors

Analog Device, Inc.
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability and SuicidalityFour times daily up to one weekPrediction of Suicidality outcome measured by the Columbia Suicide Severity scale (higher score means more suicidal)

Countries

United States

Contacts

Primary ContactDavid Sheridan, MD
sheridda@ohsu.edu503-494-1691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026