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Adolescent Idiopathic Scoliosis and Mental Health

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ClinicalTrials.gov Identifier: NCT00445393
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : January 6, 2009
Sponsor:
Information provided by:
University of British Columbia

Brief Summary:
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 or disease
Scoliosis

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Psychiatric Disorders in Adolescents With Idiopathic Scoliosis: A Pilot Study of a Validated Screening Tool
Study Start Date : October 2006
Actual Study Completion Date : October 2008

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Christopher Reilly, University of British Columbia
ClinicalTrials.gov Identifier: NCT00445393     History of Changes
Other Study ID Numbers: H05-70606
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: January 2009

Keywords provided by University of British Columbia:
Observation
Mental health
Scoliosis
Screening
Adolescent idiopathic scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases