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

Florida International University154 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

154

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Methylphenidate 0.15 mg/kgDRUG

0.15 m/kg/dose immediate-release methylphenidate

Low-Intensity BMODBEHAVIORAL

Lower-intensity behavioral treatment package.

Methylphenidate 0.3 mg/kgDRUG

0.3 mg/kg/dose immediate-release methylphenidate

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (2)

Florida International University Center for Children and Families

Miami, Florida, United States

Center for Children and Families, University at Buffalo

Buffalo, New York, United States

Outcomes

Primary Outcomes

Social Behavior-Negative Verbalizations

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.

Time frame: Daily for 45 days

Classroom Behavior

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

Time frame: Daily for 45 days

Secondary Outcomes

Treatment Satisfaction

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

Time frame: End of Treatment

Data from ClinicalTrials.gov

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