SuicideNCT01594138
Linguistic Characteristics of Suicidal Patients in the Emergency Department
An observational study of Suicide, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide
- What is being tested?
- Standardized questionnaires and a ubiquitous questionnaire
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child
Study population: CCHMC suicidal and non-suicidal adolescents
Who may be able to join
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hopsital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Standardized questionnaires and a ubiquitous questionnaire
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized questionnaires and a ubiquitous questionnaireOther
Columbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011)
| Study group | Role | What they receive |
|---|---|---|
| Suicidal Subjects | Suicidal Subjects Receives: Other: Standardized questionnaires and a ubiquitous questionnaire | |
| Non-Suicidal Control Subjects | Non-Suicidal Control Subjects Receives: Other: Standardized questionnaires and a ubiquitous questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between questionnaire responses from adolescents with and without suicidal behavior
Measured: At time of questinnaire administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionJul 2014
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.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Pestian, PhD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594138
- Sponsor's protocol ID
- 2008-1421
- Status last verified
- Feb 2017
- First submitted
- 30 Apr 2012
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linguistic Characteristics of Suicidal Patients in the ED (Emergency Department)
- ClinicalTrials.gov ID
- NCT01594138
- Acronym / sponsor ID
- 2008-1421
- Conditions
- Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 May 2012 (estimated)
- 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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicidal Subjects | – | Other: Standardized questionnaires and a ubiquitous questionnaireSuicidal Subjects |
| Non-Suicidal Control Subjects | – | Other: Standardized questionnaires and a ubiquitous questionnaireNon-Suicidal Control Subjects |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- CCHMC suicidal and non-suicidal adolescents
Key inclusion criteria (10 listed)
- 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
- Subjects age 13 years 0 months to 17 years, 11 months old
Key exclusion criteria (5 listed)
- 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
- 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.
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 |
|---|---|---|
| Standardized questionnaires and a ubiquitous questionnaireColumbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011) | Other | Non-Suicidal Control Subjects, Suicidal Subjects |
Primary outcome
Differences between questionnaire responses from adolescents with and without suicidal behavior
Time frame: At time of questinnaire administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
Related trials for Suicide
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
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. This study is not recruiting at the moment.
John Pestian, PhD principal investigator
Cincinnati Childrens Hospital Medical Center
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, run by Children's Hospital Medical Center, Cincinnati 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 15 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between questionnaire responses from adolescents with and without suicidal behavior (time frame: At time of questinnaire administration). 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 15 Feb 2017.