NCT00958373

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 6, 2015

Status Verified

June 1, 2011

Enrollment Period

4.4 years

First QC Date

August 12, 2009

Last Update Submit

May 5, 2015

Conditions

Keywords

Scoliosisadolescent idiopathic scoliosisspine curvepediatricmental healthscreening

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

ScoliosisPsychological Well-Being

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPersonal SatisfactionBehavior

Study Officials

  • Christopher Reilly, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

October 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 6, 2015

Record last verified: 2011-06

Locations