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

NCT ID: NCT00179894

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2009-07-31

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Physician training

Physician participants will receive training in guidelines and medication monitoring

Group Type: EXPERIMENTAL

Physician training

Intervention Type: BEHAVIORAL

Physicians are trained in guidelines for medication management.

2

Physician participants will provide usual care and no special intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physician training

Physicians are trained in guidelines for medication management.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

John V. Lavigne

Chief Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John V. Lavigne, PhD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R01MH066866

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 82-SECH

Identifier Type: -

Identifier Source: secondary_id

R01MH066866

Identifier Type: NIH

Identifier Source: org_study_id

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