AdolescentsNCT00623493
Detecting Risk of Suicide in a Pediatric Emergency Department
An observational study of Adolescents and Mental Disorder Diagnosed in Childhood, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
Trial summary
Objective: The ultimate goal of this project is to enhance the capacity of non-mental health clinicians working in an Emergency Departments (ED) to recognize and initiate further evaluation of children and adolescents at risk for suicide. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Adolescents, Mental Disorder Diagnosed in Childhood, Suicide Prevention
- How many people
- 524 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Feb 2008to 30 May 2018
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient must complete triage assessment at the PEDIATRIC ED.
- For the medical patients, triage level must be 2, 3, 4 or 5, and the patient must be medically stable. For medical patients in triage level 2, in order to determine if the patient is medically stable, the interviewer will contact the ED clinician (nurse or physician) prior to approaching the patient. Any patient deemed medically unstable will not be included in the study. For the psychiatric patients, leveling is not conducted in the same way. Therefore, triage level will not be considered an exclusion factor.
- Triage level in the PEDIATRIC EDs is defined by the Emergency Severity Index (ESI). ESI is a five-level ED triage algorithm that uses acuity and resource needs to stratify patients into five clinically relevant groups from 1 (most urgent) to 5 (least urgent) (Gilboy, 2005).
- Age: 10-21 years.
- English speaking
- A legal guardian must provide informed consent and patient must sign an assent document.
Who cannot join
- Developmental disability, severe cognitive impairment or communication disorder such that patient will not be able to comprehend the questions or communicate their answers
- Triage level of 1 (for medical patients), indicating that the patient is not medically stable
- Patient is not present with a legal guardian who can provide informed consent
- Patient is non-English speaking (unfortunately, the SIQ is not available at this time in Spanish or any other languages)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Childrens Hospital, Boston
Boston, Massachusetts, 02115
Nationwide Children's Hospital
Columbus, Ohio
Childrens National Medical Center
Washington D.C., District of Columbia
About this study
Objective:
The ultimate goal of this project is to enhance the capacity of non-mental health clinicians working in an Emergency Departments (ED) to recognize and initiate further evaluation of children and adolescents at risk for suicide.
Read more
Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a pediatric ED mental health population in the Children s National Medical Center (CNMC) ED.
Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to the CNMC ED for non-mental health reasons.
Study population:
The study population includes all patients admitted to the CNMC Emergency Department, ages 10 to 21, during the data collection weeks of the study period. Both patients admitted for mental health and non-mental health reasons will be included in the study.
Design:
This will be a prospective instrument development /validation study. During a designated study week, all mental health patients and a random subset of non-mental health patients admitted to the CNMC ED will be approached after their triage assessment. Following informed consent and assent, a 17-item suicide assessment tool created for this research project (RSQ-Revised), as well as a brief background questionnaire will be administered. These questions will be validated against a gold standard suicide assessment questionnaire, which will be administered to the subjects directly after the RSQ-Revised. The study aims to develop a brief suicide screening tool to be used at triage for all patients entering the ED.
Measures
Measures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).
Read the detailed description
Objective:
The ultimate goal of this project is to enhance the capacity of non-mental health clinicians working in an Emergency Department (ED) to recognize and initiate further evaluation of children and adolescents at risk for suicide.
- Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a pediatric ED mental health population.
- Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to a pediatric ED for non-mental health reasons.
Study population:
This is a multi-site study and will include all patients admitted to three pediatric EDs (the Children s National Medical Center (CNMC) ED, Children s Hospital Boston (CHB) ED, and Nationwide Children s Hospital (NCH) ED), ages 10 to 21, during the data collection days of the study period. Both patients admitted for mental health and non-mental health reasons will be included in the study.
For ease of reading, from here on in, the three pediatric EDs participating in this multi-site study will be referred to as the PEDIATRIC ED.
Design:
This will be a prospective instrument development / validation study. During 5 to 10 weekdays of the month, all mental health patients and a random subset of non-mental health patients admitted to the PEDIATRIC ED will be approached after their triage assessment. Following informed consent and assent, a 17-item suicide assessment tool created for this research project (RSQ-Revised), as well as a brief background questionnaire will be administered. These questions will be validated against a gold standard suicide assessment questionnaire, which will be administered to the subjects directly after the RSQ-Revised. The study aims to develop a brief suicide screening tool to be used at triage for all patients entering the ED.
Measures
Measures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).
- Keywords
- Screening, Suicide, Emergency Department, Children and Adolescents, Suicide Risk
- Medical subject headings
- Suicide Prevention, Suicide, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive score on suicide assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study start7 Feb 2008
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Time perspective
- Prospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa M Horowitz, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623493
- Sponsor's protocol ID
- 999908070
- Other IDs
- 08-M-N070
- Status last verified
- 30 May 2018
- First submitted
- 24 Feb 2008
- Last updated
- 1 Jun 2018
- Results posted
- No
Publications
Bancroft J, Hawton K, Simkin S, Kingston B, Cumming C, Whitwell D. The reasons people give for taking overdoses: a further inquiry. Br J Med Psychol. 1979 Dec;52(4):353-65. doi: 10.1111/j.2044-8341.1979.tb02536.x.
PubMed 508651Baumeister RF. Suicide as escape from self. Psychol Rev. 1990 Jan;97(1):90-113. doi: 10.1037/0033-295x.97.1.90.
PubMed 2408091Bearman PS, Moody J. Suicide and friendships among American adolescents. Am J Public Health. 2004 Jan;94(1):89-95. doi: 10.2105/ajph.94.1.89.
PubMed 14713704
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Risk of Suicide in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00623493
- Acronym / sponsor ID
- 999908070
- Keywords
- Screening, Suicide, Emergency Department, Children and Adolescents, Suicide Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 7 Feb 2008
- Study completion
- 30 May 2018
- First posted
- 26 Feb 2008 (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.
Objective:
The ultimate goal of this project is to enhance the capacity of non-mental health clinicians working in an Emergency Departments (ED) to recognize and initiate further evaluation of children and adolescents at risk for suicide.
Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a pediatric ED mental health population in the Children s National Medical Center (CNMC) ED.
Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to the CNMC ED for non-mental health reasons.
Study population:
The study population includes all patients admitted to the CNMC Emergency Department, ages 10 to 21, during the data collection weeks of the study period. Both patients admitted for mental health and non-mental health reasons will be included in the study.
Design:
This will be a prospective instrument development /validation study. During a designated study week, all mental health patients and a random subset of non-mental health patients admitted to the CNMC ED will be approached after their triage assessment. Following informed consent and assent, a 17-item suicide assessment tool created for this research project (RSQ-Revised), as well as a brief background questionnaire will be administered. These questions will be validated against a gold standard suicide assessment questionnaire, which will be administered to the subjects directly after the RSQ-Revised. The study aims to develop a brief suicide screening tool to be used at triage for all patients entering the ED.
Measures
Measures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).
Detailed description
Objective:
The ultimate goal of this project is to enhance the capacity of non-mental health clinicians working in an Emergency Department (ED) to recognize and initiate further evaluation of children and adolescents at risk for suicide.
- Aim 1: To re-validate the Risk of Suicide Questionnaire (RSQ), a screening tool that assists non-psychiatric clinicians in rapidly detecting suicide risk in pediatric patients, in a pediatric ED mental health population.
- Aim 2: To determine the utility of a suicide screening tool, a revised version of the Risk of Suicide Questionnaire, to detect suicide risk in pediatric patients presenting to a pediatric ED for non-mental health reasons.
Study population:
This is a multi-site study and will include all patients admitted to three pediatric EDs (the Children s National Medical Center (CNMC) ED, Children s Hospital Boston (CHB) ED, and Nationwide Children s Hospital (NCH) ED), ages 10 to 21, during the data collection days of the study period. Both patients admitted for mental health and non-mental health reasons will be included in the study.
For ease of reading, from here on in, the three pediatric EDs participating in this multi-site study will be referred to as the PEDIATRIC ED.
Design:
This will be a prospective instrument development / validation study. During 5 to 10 weekdays of the month, all mental health patients and a random subset of non-mental health patients admitted to the PEDIATRIC ED will be approached after their triage assessment. Following informed consent and assent, a 17-item suicide assessment tool created for this research project (RSQ-Revised), as well as a brief background questionnaire will be administered. These questions will be validated against a gold standard suicide assessment questionnaire, which will be administered to the subjects directly after the RSQ-Revised. The study aims to develop a brief suicide screening tool to be used at triage for all patients entering the ED.
Measures
Measures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient must complete triage assessment at the PEDIATRIC ED.
- For the medical patients, triage level must be 2, 3, 4 or 5, and the patient must be medically stable. For medical patients in triage level 2, in order to determine if the patient is medically stable, the interviewer will contact the ED clinician (nurse or physician) prior to approaching the patient. Any patient deemed medically unstable will not be included in the study. For the psychiatric patients, leveling is not conducted in the same way. Therefore, triage level will not be considered an exclusion factor.
- Triage level in the PEDIATRIC EDs is defined by the Emergency Severity Index (ESI). ESI is a five-level ED triage algorithm that uses acuity and resource needs to stratify patients into five clinically relevant groups from 1 (most urgent) to 5 (least urgent) (Gilboy, 2005).
- Age: 10-21 years.
- English speaking
Key exclusion criteria (4 listed)
- Developmental disability, severe cognitive impairment or communication disorder such that patient will not be able to comprehend the questions or communicate their answers
- Triage level of 1 (for medical patients), indicating that the patient is not medically stable
- Patient is not present with a legal guardian who can provide informed consent
- Patient is non-English speaking (unfortunately, the SIQ is not available at this time in Spanish or any other languages)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive score on suicide assessment
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 1 Jun 2018.
- Background: PubMed 508651Bancroft J, Hawton K, Simkin S, Kingston B, Cumming C, Whitwell D. The reasons people give for taking overdoses: a further inquiry. Br J Med Psychol. 1979 Dec;52(4):353-65. doi: 10.1111/j.2044-8341.1979.tb02536.x.
- Background: PubMed 2408091Baumeister RF. Suicide as escape from self. Psychol Rev. 1990 Jan;97(1):90-113. doi: 10.1037/0033-295x.97.1.90.
- Background: PubMed 14713704Bearman PS, Moody J. Suicide and friendships among American adolescents. Am J Public Health. 2004 Jan;94(1):89-95. doi: 10.2105/ajph.94.1.89.
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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. This study is not recruiting at the moment.
Lisa M Horowitz, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents and Mental Disorder Diagnosed in Childhood, run by National Institute of Mental Health (NIMH) at 3 sites 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 6 inclusion and 4 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Positive score on suicide assessment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00623493, which also lists 3 linked publications.
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 1 Jun 2018.