ADHD Treatment: Comparative and Combined Dosage Effects
Overview
- Phase
- N/A
- Intervention
- Placebo
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Florida International University
- Enrollment
- 154
- Locations
- 2
- Primary Endpoint
- Social Behavior-Negative Verbalizations
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
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.
Investigators
Eligibility 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
Arms & Interventions
No Treatment
No Medication, No Behavior Modification (BMOD)
Intervention: Placebo
Low Dose Medication Only
0.15 mg/kg methylphenidate (MPH), No BMOD
Intervention: Methylphenidate 0.15 mg/kg
Medium Dose Medication Only
0.3 mg/kg MPH, No BMOD
Intervention: Methylphenidate 0.3 mg/kg
High Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, High Intensity BMOD
Intervention: High Intensity BMOD
Higher Dose Medication Only
0.6 mg/kg MPH, No BMOD
Intervention: Methylphenidate 0.6 mg/kg
Low Intensity BMOD Only
Placebo, Low Intensity BMOD
Intervention: Low-Intensity BMOD
Low Intensity BMOD Only
Placebo, Low Intensity BMOD
Intervention: Placebo
Low Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, Low Intensity BMOD
Intervention: Methylphenidate 0.15 mg/kg
Low Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, Low Intensity BMOD
Intervention: Low-Intensity BMOD
Low Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, Low Intensity BMOD
Intervention: Low-Intensity BMOD
Low Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, Low Intensity BMOD
Intervention: Methylphenidate 0.3 mg/kg
Low Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, Low Intensity BMOD
Intervention: Low-Intensity BMOD
Low Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, Low Intensity BMOD
Intervention: Methylphenidate 0.6 mg/kg
High Intensity BMOD Only
Placebo, High Intensity BMOD
Intervention: High Intensity BMOD
High Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, High Intensity BMOD
Intervention: Methylphenidate 0.15 mg/kg
High Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, High Intensity BMOD
Intervention: High Intensity BMOD
High Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, High Intensity BMOD
Intervention: Methylphenidate 0.3 mg/kg
High Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, High Intensity BMOD
Intervention: Methylphenidate 0.6 mg/kg
High Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, High Intensity BMOD
Intervention: High Intensity BMOD
Outcomes
Primary Outcomes
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.
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
- Treatment Satisfaction(End of Treatment)