Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-06 @ 3:30 PM
Study NCT ID:
NCT00623493
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2008-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Risk of Suicide in a Pediatric Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 524}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05-30', 'completionDateStruct': {'date': '2018-05-30'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2008-02-24', 'studyFirstSubmitQcDate': '2008-02-24', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive score on suicide assessment'}]}, 'conditionsModule': {'keywords': ['Screening', 'Suicide', 'Emergency Department', 'Children and Adolescents', 'Suicide Risk'], 'conditions': ['Adolescents', 'Mental Disorder Diagnosed in Childhood', 'Suicide Prevention']}, 'referencesModule': {'references': [{'pmid': '508651', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2408091', 'type': 'BACKGROUND', 'citation': 'Baumeister RF. Suicide as escape from self. Psychol Rev. 1990 Jan;97(1):90-113. doi: 10.1037/0033-295x.97.1.90.'}, {'pmid': '14713704', 'type': 'BACKGROUND', 'citation': 'Bearman 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.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThe 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.\n\nAim 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.\n\nAim 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.\n\nStudy population:\n\nThe 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.\n\nDesign:\n\nThis 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.\n\nMeasures\n\nMeasures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).', 'detailedDescription': 'Objective:\n\nThe 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.\n\n* 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.\n* 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.\n\nStudy population:\n\nThis 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.\n\nFor 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.\n\nDesign:\n\nThis 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.\n\nMeasures\n\nMeasures include the proposed 17-item screening questionnaire and a gold standard assessment of suicidal ideation in adolescents, the Suicide Ideation Questionnaire (SIQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nPatient must complete triage assessment at the PEDIATRIC ED.\n\nFor 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.\n\nTriage 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).\n\nAge: 10-21 years.\n\nEnglish speaking\n\nA legal guardian must provide informed consent and patient must sign an assent document.\n\nEXCLUSION CRITERIA:\n\nDevelopmental disability, severe cognitive impairment or communication disorder such that patient will not be able to comprehend the questions or communicate their answers\n\nTriage level of 1 (for medical patients), indicating that the patient is not medically stable\n\nPatient is not present with a legal guardian who can provide informed consent\n\nPatient is non-English speaking (unfortunately, the SIQ is not available at this time in Spanish or any other languages)'}, 'identificationModule': {'nctId': 'NCT00623493', 'briefTitle': 'Detecting Risk of Suicide in a Pediatric Emergency Department', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Detecting Risk of Suicide in a Pediatric Emergency Department', 'orgStudyIdInfo': {'id': '999908070'}, 'secondaryIdInfos': [{'id': '08-M-N070'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Childrens Hospital, Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Lisa M Horowitz, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Mental Health (NIMH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}