NCT00050622

Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

ADHD Treatment: Comparative and Combined Dosage Effects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 methylphenidate, 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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	Methylphenidate 0.15 mg/kg	0.15 m/kg/dose immediate-release methylphenidate
BEHAVIORAL	Low-Intensity BMOD	Lower-intensity behavioral treatment package.
DRUG	Methylphenidate 0.3 mg/kg	0.3 mg/kg/dose immediate-release methylphenidate
DRUG	Placebo
DRUG	Methylphenidate 0.6 mg/kg	0.3 mg/kg/dose immediate-release methylphenidate
BEHAVIORAL	High Intensity BMOD	Comprehensive high-intensity Summer Treatment Program (STP)

Timeline

• Start date: 2001-09-01
• Primary completion: 2004-08-01
• Completion: 2005-06-01
• First posted: 2002-12-17
• Last updated: 2016-09-30
• Results posted: 2016-09-30

Locations

2 sites across 1 country: United States