Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician training
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Attention Deficit Hyperactivity Disorder
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)
Sites / Locations
- Ann & Robert H Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1 Physician training
2
Arm Description
Physician participants will receive training in guidelines and medication monitoring
Physician participants will provide usual care and no special intervention
Outcomes
Primary Outcome Measures
Behavior changes as rated by teachers
Secondary Outcome Measures
Behavior change as rated by parents
Behavior changes as rated by classroom observation
Relation between adherence to protocol and behavior change
Full Information
NCT ID
NCT00179894
First Posted
September 12, 2005
Last Updated
August 14, 2015
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00179894
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Physician training
Arm Type
Experimental
Arm Description
Physician participants will receive training in guidelines and medication monitoring
Arm Title
2
Arm Type
No Intervention
Arm Description
Physician participants will provide usual care and no special intervention
Intervention Type
Behavioral
Intervention Name(s)
Physician training
Intervention Description
Physicians are trained in guidelines for medication management.
Primary Outcome Measure Information:
Title
Behavior changes as rated by teachers
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Behavior change as rated by parents
Time Frame
Measured at Month 12
Title
Behavior changes as rated by classroom observation
Time Frame
Measured at Month 12
Title
Relation between adherence to protocol and behavior change
Time Frame
Measured at Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John V. Lavigne, PhD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
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