This trial is active, not recruiting.

Condition attention deficit disorder with hyperactivity
Treatments multi-setting early intervention, community intervention
Phase phase 2
Sponsor Lehigh University
Collaborator National Institute of Mental Health (NIMH)
Start date September 2001
End date August 2006
Trial size 200 participants
Trial identifier NCT00057668, DSIR CT-S, R01 MH61563, R01MH061563


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants from 3 years up to 5 years old.

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

Additional Information

Official title Prevention of Behavioral Deficits in Young ADHD Children
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Lehigh University.