ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings

This study is currently recruiting participants.
Study NCT00179894.   Last updated on August 20, 2008.   Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
Official Title  Improving Medication Use for ADHD in Primary Care
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.

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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Primary Outcome Measure  Behavior changes as rated by teachers [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Attention Deficit Disorder With Hyperactivity
Intervention  Behavioral: Physician training
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  400
Start Date  June 2003
Completion Date January 2009
Eligibility Criteria 

Inclusion Criteria:

  • Presence of ADHD
  • Not currently on medication

Exclusion Criteria:

  • No serious neurological disorders of sever mental health problems (suicidal behavior, autism)
Gender Both
Ages 6 Years to 11 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: John V. Lavigne, PhD     773-880-4824     jlavigne@childrensmemorial.org    
Contact: Susan LeBailly, PhD     312-573-7792     slebailly@childrensmemorial.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00179894
Organization ID R01 MH66866
Secondary IDs †† DSIR 82-SECH
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     John V. Lavigne, PhD     Children's Memorial Hospital    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  September 12, 2005
Last Updated Date August 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers