SuicideNCT06400810
Proximal Risk for Suicide in Adolescents
An observational study of Suicide and Mental Health Issue, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide, Mental Health Issue
- What is being tested?
- Analog Devices Inc.
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Child
Study population: All suicidal adolescents presenting with acute suicidality.
Who may be able to join
- subjects aged 13-17 years
- presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU
Portland, Oregon, 97239
David C Sheridan, MD, 5034941691, sheridda@Ohsu.edu
About this study
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.
Read the 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
- Being tested
- Analog Devices Inc.
- Keywords
- adolescent, emergency
- Medical subject headings
- Suicide, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analog Devices Inc.Device
Also called Analog
Wearable wrist device that collects Photoplethysmography, accelerometer data among other parameters.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Analog Devices Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability and Suicidality
Prediction of Suicidality outcome measured by the Columbia Suicide Severity scale (higher score means more suicidal)
Measured: 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)
Measured: Four times daily up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Jun 2023
- Primary completion30 Jun 2025
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Analog Device, Inc.
- Responsible party
- Principal investigator, Dr. David Sheridan, Oregon Health and Science University
- Investigators
- David Sheridan, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400810
- Sponsor's protocol ID
- STUDY00022262
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Risk for Suicide in Adolescents
- ClinicalTrials.gov ID
- NCT06400810
- Acronym / sponsor ID
- STUDY00022262
- Conditions
- Suicide, Mental Health Issue
- Keywords
- adolescent, emergency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Analog Device, Inc.
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suicidal Adolescent | – | Device: Analog Devices Inc.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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- All suicidal adolescents presenting with acute suicidality.
Key inclusion criteria (2 listed)
- subjects aged 13-17 years
- presenting to the ED or inpatient psychiatric unit with a chief complaint of acute suicidality or attempt.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analog Devices Inc.Also: AnalogWearable wrist device that collects Photoplethysmography, accelerometer data among other parameters. | Device | Suicidal Adolescent |
Primary outcome
Heart rate variability and Suicidality
Time frame: Four times daily up to one week
Prediction of Suicidality outcome measured by the Columbia Suicide Severity scale (higher score means more suicidal)
Heart rate variability and Suicidality
Time frame: Four times daily up to one week
Prediction of Suicidality outcome measured by the High Frequency Heart Rate Variability Metric (lower score means less parasympathetic response)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Sheridan, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Mental Health Issue, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Sheridan, MD (503-494-1691, sheridda@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability and Suicidality (time frame: Four times daily up to one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.