SuicideNCT03030924
Wearable Suicidal Early Warning System for Adolescents
An observational study of Suicide and Adolescent Behavior, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Suicide, Adolescent Behavior
- What is being tested?
- Solace
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 1 Feb 2027
- Phase
- Observational
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 19 years
- All sexes
- Child, Adult
Study population: Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency department (13-19 years of age).
Who may be able to join
- acute suicidality
- consenting individual present in the emergency department
Who cannot join
- medical admission for an ingestion or other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Adolescent Behavior
- Being tested
- Solace
- Keywords
- suicide
- Medical subject headings
- Suicide, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolaceDevice
Noninvasive physiologic monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Measured: 1 week
Secondary outcomes (5)
Gender
Measured: At enrollment
Age
in Years
Measured: at enrollment
Columbia Suicide Severity Score
Numerical based on severity
Measured: 1 week
PHQ-9 Depression Scale
Numerical based on severity
Measured: 1 week
Motion
As detected by an accelerometer in Hz
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start18 Sep 2017
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI)
- 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
- NCT03030924
- Sponsor's protocol ID
- STUDY00016409
- Other IDs
- 5K12HL133115
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheridan DC, Lin A. Emergency Department Adolescent Suicidality: A Pilot Study to Determine How Common Actual Attempts Are. Pediatr Emerg Care. 2022 Feb 1;38(2):e458-e461. doi: 10.1097/PEC.0000000000002629.
PubMed 35100750Sheridan DC, Dehart R, Lin A, Sabbaj M, Baker SD. Heart Rate Variability Analysis: How Much Artifact Can We Remove? Psychiatry Investig. 2020 Sep;17(9):960-965. doi: 10.30773/pi.2020.0168. Epub 2020 Sep 18.
PubMed 33017533