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CompletedNCT00445393Updated Jan 6, 2009

Adolescent Idiopathic Scoliosis and Mental Health

An observational study in Scoliosis, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 11 Years to 16 Years. Per ClinicalTrials.gov, last updated 2009-01-06.

Sponsored by University of British Columbia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
11 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Scoliosis

Keywords

  • Observation
  • Mental health
  • Scoliosis
  • Screening
  • Adolescent idiopathic scoliosis
03

In context

Scoliosis

603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.

This study's planned enrollment of 100 is above the median of 84 across 236 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Aadolescents undergoing spinal surgery for scoliosis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients diagnosed with AIS, between the ages of eleven and sixteen, who are scheduled to undergo surgical intervention, will be eligible to participate in the study. 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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
06

Study locations

1 site
  • BC Children's Hospital - Dept of Orthopaedics
    Vancouver, British Columbia V6H3V4, Canada
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2007
First posted
Mar 9, 2007
Start
Oct 2006
CompletionActual
Oct 2008
Last update
Jan 6, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00445393
First posted
Mar 9, 2007
Start date
Oct 2006
Completion
Oct 2008
Last update
Jan 6, 2009

Study contacts

Christopher Reilly, MD, FRCSC
principal investigator · University of British Columbia
Darin Davidson, MD, PGYIII
study director · University of British Columbia
Jane Garland, MD
study director · University of British Columbia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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