Adolescent Idiopathic Scoliosis and Mental Health

NCT ID: NCT00445393

Last Updated: 2009-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Christopher Reilly, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Darin Davidson, MD, PGYIII

Role: STUDY_DIRECTOR

University of British Columbia

Jane Garland, MD

Role: STUDY_DIRECTOR

University of British Columbia

Locations

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BC Children's Hospital - Dept of Orthopaedics

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H05-70606

Identifier Type: -

Identifier Source: org_study_id

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