NCT00307268

Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD

Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 195 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

Detailed description

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.

Conditions

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2012-12-01
• First posted: 2006-03-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: Canada