Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00179894

Purpose

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.

Condition	Intervention
Attention Deficit Disorder With Hyperactivity	Behavioral: Physician training

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Official Title:

Improving Medication Use for ADHD in Primary Care

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Behavior changes as rated by teachers [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:

400

Study Start Date:

June 2003

Estimated Study Completion Date:

January 2009

Estimated Primary Completion Date:

January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Physician training: Experimental Physician participants will receive training in guidelines and medication monitoring	Behavioral: Physician training Physicians are trained in guidelines for medication management.
2: No Intervention Physician participants will provide usual care and no special intervention

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

Ages Eligible for Study:

6 Years to 11 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Presence of ADHD
Not currently on medication

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179894

Contacts

Contact: John V. Lavigne, PhD	773-880-4824	jlavigne@childrensmemorial.org
Contact: Susan LeBailly, PhD	312-573-7792	slebailly@childrensmemorial.org

Locations

United States, Illinois
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60614
Contact: John V. Lavigne, PhD 773-880-4824 jlavigne@childrensmemorial.org
Contact: Susan LeBailly, PhD 312-573-7792 slebailly@childrensmemorial.org
Principal Investigator: John V. Lavigne, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

John V. Lavigne, PhD

Children's Memorial Hospital

More Information

Responsible Party:

Children's Memorial Hospital ( Harmony Maple )

Study ID Numbers:

R01 MH66866, DSIR 82-SECH

First Received:

September 12, 2005

Last Updated:

August 20, 2008

ClinicalTrials.gov Identifier:

NCT00179894

Health Authority:

United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

ADHD
Attention Deficit Hyperactivity Disorder

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 07, 2009