- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958373
Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis
May 5, 2015 updated by: University of British Columbia
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.
Study Overview
Status
Withdrawn
Conditions
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital Department of Orthopaedics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Reilly, Dr., University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
August 12, 2009
First Submitted That Met QC Criteria
August 12, 2009
First Posted (Estimate)
August 13, 2009
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H08-02333
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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