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| Descriptive Information Fields | |||||||||
| Brief Title † | Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings | ||||||||
| Official Title † | Improving Medication Use for ADHD in Primary Care | ||||||||
| Brief Summary | This study will determine the effectiveness of educating pediatricians about attention deficit hyperactivity disorder treatment guidelines in improving child behavior and pediatricians' adherence to medication guidelines. |
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| Detailed Description | The most effective treatment for improving the core symptoms of inattention, impulsivity and hyperactivity in children with attention deficit hyperactivity disorder (ADHD) involves the use of stimulant medications. Most children with ADHD are treated by pediatricians, but the treatment provided is often less than optimal. This study is designed to see if training for pediatricians in following guidelines for management of first-line medicines for ADHD leads to improvement in child behavior, and whether the physicians can adhere to the guidelines. Over 100 studies have shown that stimulant medications are effective for improving the core symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Approximately 70% of children who receive ADHD medications are treated by their primary care pediatrician, but studies show that management is not always optimal. The present study is designed to see if child behavior can be improved by training pediatricians in the use of guidelines for treating ADHD, and whether the physicians can adhere to the guidelines. Twenty-four pediatric practices were randomized to a treatment as usual or specialized care (receiving training in guidelines and computer assisted monitoring of patient progress and medication titration). Children are assessed with parent and teacher reports at baseline, 4-, 9-, and 12-months post initiation of treatment, and classroom observations of behavior are assessed at baseline, 6-, and 12-months. Approximately 400 children are to be enrolled. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Behavior changes as rated by teachers [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Behavior change as rated by parents [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Behavior changes as rated by classroom observation [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Relation between adherence to protocol and behavior change [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] |
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| Condition † | Attention Deficit Disorder With Hyperactivity | ||||||||
| Intervention † | Behavioral: Physician training | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 400 | ||||||||
| Start Date † | June 2003 | ||||||||
| Completion Date | January 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 11 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00179894 | ||||||||
| Organization ID | R01 MH66866 | ||||||||
| Secondary IDs †† | DSIR 82-SECH | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | August 20, 2008 | ||||||||
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