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Wearable Suicidal Early Warning System for Adolescents

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ClinicalTrials.gov Identifier: NCT03030924
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
Welch Allyn
Information provided by (Responsible Party):
Dr. David Sheridan, Oregon Health and Science University

Brief Summary:
This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality.

Condition or disease Intervention/treatment
Suicide Adolescent Behavior Device: Solace

Detailed Description:
This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality. 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. Patients will be enrolled if presenting to the pediatric emergency department with acute suicidal thoughts or attempt. Upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physiologic Parameters for Monitoring Adolescent Suicidality
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : July 3, 2019
Estimated Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources


Intervention Details:
    Device: Solace
    Noninvasive physiologic monitor


Primary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Gender [ Time Frame: At enrollment ]
  2. Age [ Time Frame: at enrollment ]
    in Years

  3. Columbia Suicide Severity Score [ Time Frame: 1 week ]
    Numerical based on severity

  4. PHQ-9 Depression Scale [ Time Frame: 1 week ]
    Numerical based on severity

  5. Motion [ Time Frame: 1 week ]
    As detected by an accelerometer in Hz


Other Outcome Measures:
  1. past Medical History [ Time Frame: At enrollment ]
  2. Medications [ Time Frame: At enrollment and daily for one week after discharge ]
    Daily medications



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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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).
Criteria

Inclusion Criteria:

  • acute suicidality
  • consenting individual present in the emergency department

Exclusion Criteria:

  • medical admission for an ingestion or other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030924


Contacts
Contact: David Sheridan, MD 5034941691 sheridda@ohsu.edu
Contact: David C Sheridan, MD 5034941691 sheridda@ohsu.edu

Locations
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: David Sheridan, MD    503-494-1691    sheridda@Ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Welch Allyn
Investigators
Principal Investigator: David Sheridan, MD Oregon Health and Science University

Responsible Party: Dr. David Sheridan, Assistant Professor of Emergency Medicine/Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03030924     History of Changes
Other Study ID Numbers: STUDY00016409
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. David Sheridan, Oregon Health and Science University:
suicide

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms