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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
Est. completion date
Est. primary completion date
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, 

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