Adolescent Idiopathic Scoliosis and Mental Health - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00445393

Purpose

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.

Condition
Scoliosis

MedlinePlus related topics: Child Mental Health Mental Health Scoliosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prevalence of Psychiatric Disorders in Adolescents With Idiopathic Scoliosis: A Pilot Study of a Validated Screening Tool

Further study details as provided by University of British Columbia:

Estimated Enrollment:	100
Study Start Date:	October 2006
Study Completion Date:	October 2008

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	11 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Aadolescents undergoing spinal surgery for scoliosis.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

All types of scoliosis besides AIS will be excluded. This includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis.
Children younger than eleven years or older than sixteen years will be excluded.
Those with additional chronic disease will be excluded, due to the possibility of confounding.
Those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded.
Existence of psychiatric disorder prior to treatment will not be cause for exclusion from the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445393

Locations

Canada, British Columbia
BC Children's Hospital - Dept of Orthopaedics
Vancouver, British Columbia, Canada, V6H3V4

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Christopher Reilly, MD, FRCSC	University of British Columbia
Study Director:	Darin Davidson, MD, PGYIII	University of British Columbia
Study Director:	Jane Garland, MD	University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Christopher Reilly )
Study ID Numbers:	H05-70606
Study First Received:	March 7, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00445393
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Observation
Mental health
Scoliosis
Screening
Adolescent idiopathic scoliosis

Study placed in the following topic categories:

Spinal Diseases
Scoliosis
Musculoskeletal Diseases
Mental Disorders
Bone Diseases

Additional relevant MeSH terms:

Spinal Curvatures

ClinicalTrials.gov processed this record on January 16, 2009