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Completed

NCT Number: NCT00050622

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University Center for Children and Families, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate 0.15 mg/kg

Drug

0.15 m/kg/dose immediate-release methylphenidate

Low-Intensity BMOD

Behavioral

Lower-intensity behavioral treatment package.

Methylphenidate 0.3 mg/kg

Drug

0.3 mg/kg/dose immediate-release methylphenidate

Placebo

Drug

Methylphenidate 0.6 mg/kg

Drug

0.3 mg/kg/dose immediate-release methylphenidate

High Intensity BMOD

Behavioral

Comprehensive high-intensity Summer Treatment Program (STP)

Primary outcomes

  1. Social Behavior-Negative Verbalizations

    Time frame: Daily for 45 days

    Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.

  2. Classroom Behavior

    Time frame: Daily for 45 days

    Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.

Secondary outcomes

  1. Treatment Satisfaction

    Time frame: End of Treatment

    Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

ADHD Treatment: Comparative and Combined Dosage Effects

Important dates

Study start
2001
Primary completion
2004
Study completion
2005
First posted
Dec 17, 2002
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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