- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594138
Linguistic Characteristics of Suicidal Patients in the Emergency Department
February 13, 2017 updated by: Children's Hospital Medical Center, Cincinnati
Linguistic Characteristics of Suicidal Patients in the ED (Emergency Department)
The purpose of this study is to determine whether patients who have a high risk for serious suicide behavior will demonstrate a speech pattern that has a relationship to language patterns found in suicide notes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In an average week the CCHMC Emergency Department (ED) evaluates 40 patients with suicidal behavior.
Currently, there is no systematic method for assessment of suicide risk in these patients and often, emergency department staff are required to make judgments about the disposition of these patients without a full understanding of the patient's risk for another serious suicide attempt.
This pilot project involves experts in child psychiatry, biomedical informatics, and emergency medicine to collect pilot data for developing a method to estimate the risk of serious suicidal behavior based on computational linguistics.
Study Type
Observational
Enrollment (Actual)
60
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
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hopsital Medical Center
-
-
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 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
CCHMC suicidal and non-suicidal adolescents
Description
Inclusion Criteria for Suicidal Subjects:
- Subjects age 13 years 0 months to 17 years, 11 months old
- Admission to CCHMC ED, psychiatric units, or medical units with suicidal behavior or attempt
- The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
- English is spoken as the primary language in the home
Inclusion Criteria for Non-Suicidal Subjects:
- Subjects age 13 years 0 months to 17 years, 11 months old
- Admission to CCHMC ED with no current or no history of suicide ideation/attempt/gesture
- No past or current history of a major mood disorder
- No history of death by suicide in first-degree relatives
- The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
- English is spoken as the primary language in the home
Exclusion Criteria for Suicidal Subjects:
- Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol
- Level of consciousness precludes consent and research assessments
- Unable to assent because of severe mental retardation or incapacitating psychosis
Exclusion Criteria for Non-Suicidal Subjects:
- Any current or past suicide attempts
- Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suicidal Subjects
|
Columbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011)
|
|
Non-Suicidal Control Subjects
|
Columbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Differences between questionnaire responses from adolescents with and without suicidal behavior
Time Frame: At time of questinnaire administration
|
At time of questinnaire administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Pestian, PhD, Cincinnati Childrens Hospital Medical Center
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
September 1, 2009
Primary Completion (ACTUAL)
November 1, 2011
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
April 30, 2012
First Submitted That Met QC Criteria
May 7, 2012
First Posted (ESTIMATE)
May 8, 2012
Study Record Updates
Last Update Posted (ACTUAL)
February 15, 2017
Last Update Submitted That Met QC Criteria
February 13, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-1421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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