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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00050622
First received: December 16, 2002
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate
Behavioral: Comprehensive behavioral treatment program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: ADHD Treatment: Comparative and Combined Dosage Effects

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Estimated Enrollment: 144
Study Start Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050622

Locations
United States, New York
Center for Children and Families, University at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
  More Information

Additional Information:
No publications provided

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00050622     History of Changes
Other Study ID Numbers: R01 MH62946, R01MH062946, DSIR CT-CT
Study First Received: December 16, 2002
Last Updated: November 3, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014