Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00445393
Status:
COMPLETED
Last Update Posted:
2009-01-06
First Post:
2007-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adolescent Idiopathic Scoliosis and Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-05', 'studyFirstSubmitDate': '2007-03-07', 'studyFirstSubmitQcDate': '2007-03-08', 'lastUpdatePostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Observation', 'Mental health', 'Scoliosis', 'Screening', 'Adolescent idiopathic scoliosis'], 'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.', 'detailedDescription': 'This study is a cross-sectional pilot study investigating the prevalence of psychiatric illness at various time points in the course of treatment of AIS. Three independent sets of questionnaires will be administered during a single scheduled clinical visit. There will be no clinical visits for the exclusive purpose of completing questionnaires. The first questionnaire will be the SRS outcome instrument. The second questionnaire will be the Achenbach YSR, completed by the adolescents, and the parents will be asked to complete the CBCL. Finally, a generic outcome measure specific to children and adolescents, the Pediatric Outcome Data Collection Instrument, will be administered. The time requirement to complete these questionnaires is anticipated to be approximately 45 minutes. The Achenbach questionnaires will be scored promptly after each is completed using the provided scoring templates. This data will be used to identify those at risk and make appropriate resources available. This would provide appropriate care for adolescents at high risk of mental health disorder by identifying those at risk via a non-invasive screening tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Aadolescents undergoing spinal surgery for scoliosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed with AIS, between the ages of eleven and sixteen, who are scheduled to undergo surgical intervention, will be eligible to participate in the study. The patient and one parent will be required to complete the questionnaires in their entirety at the predetermined time points. There are several different methods of surgical intervention for AIS, however there will be no selection on the basis of the type of intervention. Curve pattern and severity will, similarly, not be used as inclusion criteria.\n\nExclusion Criteria:\n\n* All types of scoliosis besides AIS will be excluded. This includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis.\n* Children younger than eleven years or older than sixteen years will be excluded.\n* Those with additional chronic disease will be excluded, due to the possibility of confounding.\n* Those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded.\n* Existence of psychiatric disorder prior to treatment will not be cause for exclusion from the study.'}, 'identificationModule': {'nctId': 'NCT00445393', 'briefTitle': 'Adolescent Idiopathic Scoliosis and Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Prevalence of Psychiatric Disorders in Adolescents With Idiopathic Scoliosis: A Pilot Study of a Validated Screening Tool', 'orgStudyIdInfo': {'id': 'H05-70606'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital - Dept of Orthopaedics", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Christopher Reilly, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Darin Davidson, MD, PGYIII', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Jane Garland, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Christopher Reilly', 'oldOrganization': 'University of British Columbia'}}}}