Clinical trial NCT00179894: Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
Official title: Improving Medication Use for ADHD in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Attention Deficit Hyperactivity Disorder
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 270
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Behavior changes as rated by teachers
timeFrame: Measured at Month 12
Secondary outcomes:
measure: Behavior change as rated by parents
timeFrame: Measured at Month 12
measure: Behavior changes as rated by classroom observation
timeFrame: Measured at Month 12
measure: Relation between adherence to protocol and behavior change
timeFrame: Measured at Month 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: John V. Lavigne, PhD
role: PRINCIPAL_INVESTIGATOR
References: