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Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00958373
Recruitment Status : Withdrawn (Didn't have the resources necessary to carry out the study)
First Posted : August 13, 2009
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):

Study Description
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
Adolescent Idiopathic 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 Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis
Study Start Date : October 2006
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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
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.

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.
Contacts and Locations

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): NCT00958373

Canada, British Columbia
British Columbia Children's Hospital Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Christopher Reilly, Dr. University of British Columbia
More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00958373     History of Changes
Other Study ID Numbers: H08-02333
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: June 2011

Keywords provided by University of British Columbia:
adolescent idiopathic scoliosis
spine curve
mental health

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Behavioral Symptoms