Proximal Risk for Suicide in Adolescents

NCT ID: NCT06400810

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2026-07-01

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.

Conditions

Suicide; Mental Health Issue

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Analog Devices Inc.

Intervention Type: DEVICE

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

Interventions

Analog Devices Inc.

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

Intervention Type: DEVICE

Other Intervention Names

Analog

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Analog Device, Inc.

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Dr. David Sheridan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Sheridan, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Sheridan, MD

Role: CONTACT

sheridda@ohsu.edu

503-494-1691

Facility Contacts

David C Sheridan, MD

Role: primary

sheridda@Ohsu.edu

5034941691

Other Identifiers

STUDY00022262

Identifier Type: -

Identifier Source: org_study_id