Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD
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Purpose
To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials
| Condition |
|---|
|
Attention-Deficit/Hyperactivity Disorder (ADHD) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care |
| Enrollment: | 195 |
| Study Start Date: | March 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
This is a prospective, long-term, observational study of routine clinical care. The study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the Provincial ADHD Program. The study is designed for systematic follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or whether they elect to receive medication treatment. Evaluations occur every 6 months for 24 months. The population to be examined is children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment. No studies have been conducted that have evaluated the outcome of core ADHD symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. Two hundred patients will be enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment.
Inclusion Criteria:
Meet DSM-IV criteria for ADHD
Exclusion Criteria:
None
Contacts and Locations| Canada, British Columbia | |
| Children's and Women's Health Centre of BC | |
| Vancouver, British Columbia, Canada | |
| Principal Investigator: | Margaret Weiss, MD, PhD | The University of British Columbia |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00307268 History of Changes |
| Other Study ID Numbers: | H05-70361 |
| Study First Received: | March 23, 2006 |
| Last Updated: | January 21, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
ADHD Effectiveness |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 13, 2013