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Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00179894
  Purpose

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

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

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
1 Physician training: Experimental
Physician participants will receive training in guidelines and medication monitoring
Behavioral: Physician training
Physicians are trained in guidelines for medication management.
2: No Intervention
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.

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179894

Contacts
Contact: John V. Lavigne, PhD 773-880-4824 jlavigne@childrensmemorial.org
Contact: Susan LeBailly, PhD 312-573-7792 slebailly@childrensmemorial.org

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: John V. Lavigne, PhD Children's Memorial Hospital
  More Information

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

Keywords provided by National Institute of Mental Health (NIMH):
ADHD
Attention Deficit Hyperactivity Disorder

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 30, 2009