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Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings

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ClinicalTrials.gov Identifier: NCT00179894
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 17, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Attention Deficit Disorder With Hyperactivity Behavioral: Physician training

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Medication Use for ADHD in Primary Care
Study Start Date : June 2003
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Physician training
Physician participants will receive training in guidelines and medication monitoring
Behavioral: Physician training
Physicians are trained in guidelines for medication management.
No Intervention: 2
Physician participants will provide usual care and no special intervention

Outcome Measures

Primary Outcome Measures :
  1. Behavior changes as rated by teachers [ Time Frame: Measured at Month 12 ]

Secondary Outcome Measures :
  1. Behavior change as rated by parents [ Time Frame: Measured at Month 12 ]
  2. Behavior changes as rated by classroom observation [ Time Frame: Measured at Month 12 ]
  3. Relation between adherence to protocol and behavior change [ Time Frame: Measured at Month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presence of ADHD
  • Not currently on medication

Exclusion Criteria:

  • No serious neurological disorders of sever mental health problems (suicidal behavior, autism)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179894

United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Mental Health (NIMH)
Principal Investigator: John V. Lavigne, PhD Ann & Robert H Lurie Children's Hospital of Chicago
More Information

Responsible Party: John V. Lavigne, Chief Psychologist, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT00179894     History of Changes
Other Study ID Numbers: R01MH066866 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015

Keywords provided by John V. Lavigne, Ann & Robert H Lurie Children's Hospital of Chicago:
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms