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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Improving Medication Use for ADHD in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179894
• Other study ID #: R01MH066866
• Secondary ID: R01MH066866DSIR
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 14, 2015
• Start date: June 2003
• Est. completion date: July 2009

Study information

• Verified date: August 2015
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• Presence of ADHD

• Not currently on medication

Exclusion Criteria:

• No serious neurological disorders of sever mental health problems (suicidal behavior, autism)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• Physician training
Physicians are trained in guidelines for medication management.

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior changes as rated by teachers		Measured at Month 12	No
Secondary	Behavior change as rated by parents		Measured at Month 12	No
Secondary	Behavior changes as rated by classroom observation		Measured at Month 12	No
Secondary	Relation between adherence to protocol and behavior change		Measured at Month 12	No