ScoliosisNCT00445393
Adolescent Idiopathic Scoliosis and Mental Health
An observational study of Scoliosis, run by University of British Columbia at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Scoliosis
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Aadolescents undergoing spinal surgery for scoliosis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital - Dept of Orthopaedics
Vancouver, British Columbia, V6H3V4
About this study
Official title: Prevalence of Psychiatric Disorders in Adolescents With Idiopathic Scoliosis: A Pilot Study of a Validated Screening Tool
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.
- Conditions
- Scoliosis
- Keywords
- Observation, Mental health, Scoliosis, Screening, Adolescent idiopathic scoliosis
- Medical subject headings
- Scoliosis, Psychological Well-Being
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startOct 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Reilly, MD, FRCSC, Principal investigator, University of British ColumbiaDarin Davidson, MD, PGYIII, Study director, University of British ColumbiaJane Garland, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445393
- Sponsor's protocol ID
- H05-70606
- Status last verified
- Jan 2009
- First submitted
- 7 Mar 2007
- Last updated
- 6 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Psychiatric Disorders in Adolescents With Idiopathic Scoliosis: A Pilot Study of a Validated Screening Tool
- ClinicalTrials.gov ID
- NCT00445393
- Acronym / sponsor ID
- H05-70606
- Conditions
- Scoliosis
- Keywords
- Observation, Mental health, Scoliosis, Screening, Adolescent idiopathic scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Aadolescents undergoing spinal surgery for scoliosis.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2009.
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2009.