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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John V. Lavigne, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179894
First received: September 12, 2005
Last updated: May 3, 2013
Last verified: March 2009

September 12, 2005
May 3, 2013
June 2003
July 2009   (final data collection date for primary outcome measure)
Behavior changes as rated by teachers [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Behavior changes are rated by teachers
Complete list of historical versions of study NCT00179894 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Behavior change as rated by parents
  • Behavior changes as rated by classroom observation
  • Relation between adherence to protocol and behavior change
Not Provided
Not Provided
 
Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
Improving Medication Use for ADHD in Primary Care

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Behavioral: Physician training
Physicians are trained in guidelines for medication management.
  • Experimental: 1 Physician training
    Physician participants will receive training in guidelines and medication monitoring
    Intervention: Behavioral: Physician training
  • No Intervention: 2
    Physician participants will provide usual care and no special intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of ADHD
  • Not currently on medication

Exclusion Criteria:

  • No serious neurological disorders of sever mental health problems (suicidal behavior, autism)
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179894
R01 MH066866, R01MH066866, DSIR 82-SECH
No
John V. Lavigne, Ann & Robert H Lurie Children's Hospital of Chicago
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
Ann & Robert H Lurie Children's Hospital of Chicago
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP