Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
John V. Lavigne, Ann & Robert H Lurie Children's Hospital of Chicago Identifier:
First received: September 12, 2005
Last updated: May 3, 2013
Last verified: March 2009

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
Attention Deficit Disorder With Hyperactivity
Behavioral: Physician training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Medication Use for ADHD in Primary Care

Resource links provided by NLM:

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Behavior changes as rated by teachers [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 270
Study Start Date: June 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00179894

United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: John V. Lavigne, PhD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: John V. Lavigne, Chief Psychologist, Ann & Robert H Lurie Children's Hospital of Chicago Identifier: NCT00179894     History of Changes
Other Study ID Numbers: R01 MH066866, R01MH066866, DSIR 82-SECH
Study First Received: September 12, 2005
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Keywords provided by 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
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on February 27, 2015