Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis

This study has been terminated.
(Didn't have the resources necessary to carry out the study)
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00958373
First received: August 12, 2009
Last updated: June 13, 2011
Last verified: June 2011

August 12, 2009
June 13, 2011
October 2006
March 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00958373 on ClinicalTrials.gov Archive Site
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Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis
Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients between the ages of eleven and sixteen who may have a prevalence of psychiatric illness at various time points in the course of treatment of AIS.

Adolescent Idiopathic Scoliosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with AIS between the ages of eleven and sixteen, scheduled to undergo surgical intervention
  • 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.
Both
11 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00958373
H08-02333
Not Provided
Dr. Christopher Reilly, University of British Columbia
University of British Columbia
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Principal Investigator: Christopher Reilly, Dr. University of British Columbia
University of British Columbia
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP