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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00179894 |
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.
Condition | Intervention |
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Attention Deficit Disorder With Hyperactivity |
Behavioral: Physician training |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Improving Medication Use for ADHD in Primary Care |
Estimated Enrollment: | 400 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Physician training: Experimental
Physician participants will receive training in guidelines and medication monitoring
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Behavioral: Physician training
Physicians are trained in guidelines for medication management.
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2: No Intervention
Physician participants will provide usual care and no special intervention
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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.
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John V. Lavigne, PhD | 773-880-4824 | jlavigne@childrensmemorial.org |
Contact: Susan LeBailly, PhD | 312-573-7792 | slebailly@childrensmemorial.org |
United States, Illinois | |
Children's Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: John V. Lavigne, PhD 773-880-4824 jlavigne@childrensmemorial.org | |
Contact: Susan LeBailly, PhD 312-573-7792 slebailly@childrensmemorial.org | |
Principal Investigator: John V. Lavigne, PhD |
Principal Investigator: | John V. Lavigne, PhD | Children's Memorial Hospital |
Responsible Party: | Children's Memorial Hospital ( Harmony Maple ) |
Study ID Numbers: | R01 MH66866, DSIR 82-SECH |
Study First Received: | September 12, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00179894 |
Health Authority: | United States: Federal Government |
ADHD Attention Deficit Hyperactivity Disorder |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Pathologic Processes Disease Nervous System Diseases |