Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00958373
(Didn't have the resources necessary to carry out the study)
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.
Condition or disease
Adolescent Idiopathic Scoliosis
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
11 Years to 16 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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.