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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

ADHD Treatment: Comparative and Combined Dosage Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050622
• Other study ID #: R01MH062946
• Secondary ID: R01MH062946DSIR
• Status: Completed
• Phase: N/A
• First received: December 16, 2002
• Last updated: November 3, 2011
• Start date: September 2001

Study information

• Verified date: November 2011
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate

Behavioral:
• Comprehensive behavioral treatment program

Locations

Country	Name	City	State
United States	Center for Children and Families, University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

External Links

•   Center for Children and Families Home Page