Wearable Suicidal Early Warning System for Adolescents

August 14, 2025 updated by: Dr. David Sheridan, Oregon Health and Science University

Physiologic Parameters for Monitoring Adolescent Suicidality

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality or are admitted to an inpatient psychiatric adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends associated with suicidality noninvasively in an objective manner beyond subjective questionnaires currently available. Upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency department (13-19 years of age).

Description

Inclusion Criteria:

  • acute suicidality
  • consenting individual present in the emergency department

Exclusion Criteria:

  • medical admission for an ingestion or other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart Rate Variability
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: At enrollment
At enrollment
Age
Time Frame: at enrollment
in Years
at enrollment
Columbia Suicide Severity Score
Time Frame: 1 week
Numerical based on severity
1 week
PHQ-9 Depression Scale
Time Frame: 1 week
Numerical based on severity
1 week
Motion
Time Frame: 1 week
As detected by an accelerometer in Hz
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
past Medical History
Time Frame: At enrollment
At enrollment
Medications
Time Frame: At enrollment and daily for one week after discharge
Daily medications
At enrollment and daily for one week after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute of Mental Health (NIMH)
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: David Sheridan, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

June 30, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 21, 2017

First Submitted That Met QC Criteria

January 21, 2017

First Posted (Estimated)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00016409
  • 5K12HL133115 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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