The purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). This study will also examine the interactions between different levels of behavioral and drug treatments.

Official Title

ADHD Treatment: Comparative and Combined Dosage Effects

Conditions

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Participants attend a summer treatment program each Monday-Friday for 9 weeks. They participate in group recreational and classroom activities, with 12 children and 5 staff per group. Three behavioral conditions (no behavioral modification, low-intensity behavioral modification, and high-intensity behavioral modification) are delivered in random order, with each condition lasting 3 weeks. Along with the behavioral treatment conditions, children receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg methlyphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily and repeated 3 or 4 times within each behavioral treatment condition. Measures include frequency counts of positive and negative behaviors, academic productivity and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and side effects. Parents attend training sessions and implement behavioral programs at home.

Study Start

Eligibility & Criteria

Ages Eligible for Study: 5 Years – 12 Years, Genders Eligible for Study: Both Criteria Inclusion Criteria:Attention Deficit Hyperactivity Disorder IQ >= 80 Exclusion Criteria:- History of seizures or other neurological problems – Medical history that would involve considerable risk in taking stimulant medication – History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder

Total Enrolment

144

Contact Details

(Source: National Institute of Mental Health (NIMH): Clinical Trials: June 2004)