Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis

Sponsor
University of British Columbia (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00958373
Collaborator
(none)
0
1
53
0

Study Details

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 Intervention/Treatment Phase

    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 :
    Oct 1, 2006
    Actual Primary Completion Date :
    Mar 1, 2011
    Actual Study Completion Date :
    Mar 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      11 Years to 16 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 British Columbia Children's Hospital Department of Orthopaedics Vancouver British Columbia Canada V6H 3V4

      Sponsors and Collaborators

      • University of British Columbia

      Investigators

      • Principal Investigator: Christopher Reilly, Dr., University of British Columbia

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of British Columbia
      ClinicalTrials.gov Identifier:
      NCT00958373
      Other Study ID Numbers:
      • H08-02333
      First Posted:
      Aug 13, 2009
      Last Update Posted:
      May 6, 2015
      Last Verified:
      Jun 1, 2011
      Keywords provided by University of British Columbia
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of May 6, 2015