Preventing Behavior Problems in Children With ADHD - Tabular View

Tracking Information
First Received Date ^ICMJE	April 4, 2003
Last Updated Date	August 15, 2006
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Preventing Behavior Problems in Children With ADHD
Official Title ^ICMJE	Prevention of Behavioral Deficits in Young ADHD Children
Brief Summary	This study will determine the effectiveness of a combination of treatments in preventing behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD) in young children.
Detailed Description	Participants are randomly assigned to either a Multi-Setting Early Intervention group or to a Community Intervention group. The Early Intervention group receives parent training and assessment-based behavioral and academic intervention for 1 year, followed by either a high or a low intensity maintenance intervention for an additional 18 months. The Community Intervention group members receive psychotropic medication, special education services, and monthly sessions to obtain information about child development and medical functioning for 2 years. Participants are assessed on six occasions over 4 years. Parents and teachers assess children's behavior, academic performance, and archival data, including medical and school records.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Attention Deficit Disorder With Hyperactivity
Intervention ^ICMJE	Behavioral: Multi-Setting Early Intervention Behavioral: Community Intervention
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	200
Completion Date	August 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Attention Deficit Hyperactivity Disorder (ADHD) diagnosis Preschool, nursery school, or group daycare enrollment at least 2 days per week Parents who can communicate in English Exclusion Criteria: Plans to move out of the area in the near future Mental retardation, neurological damage, significant motor or physical impairments, or autism or other pervasive developmental disorder Inattentive ADHD or conduct disorder
Gender	Both
Ages	3 Years to 5 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00057668
Responsible Party
Study ID Numbers ^ICMJE	R01 MH61563, DSIR CT-S
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	August 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP