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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ADHD Treatment: Comparative and Combined Dosage Effects

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Methylphenidate 0.15 mg/kg
* Behavioral: Low-Intensity BMOD
* Drug: Methylphenidate 0.3 mg/kg
* Drug: Placebo
* Drug: Methylphenidate 0.6 mg/kg
* Behavioral: High Intensity BMOD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No Treatment<br>No Medication, No Behavior Modification (BMOD) | Drug: Placebo<br> <br> |
| Active Comparator: Low Dose Medication Only<br>0.15 mg/kg methylphenidate (MPH), No BMOD | Drug: Methylphenidate 0.15 mg/kg<br>* 0.15 m/kg/dose immediate-release methylphenidate<br>|
| Active Comparator: Medium Dose Medication Only<br>0.3 mg/kg MPH, No BMOD | Drug: Methylphenidate 0.3 mg/kg<br>* 0.3 mg/kg/dose immediate-release methylphenidate<br>|
| Active Comparator: Higher Dose Medication Only<br>0.6 mg/kg MPH, No BMOD | Drug: Methylphenidate 0.6 mg/kg<br>* 0.3 mg/kg/dose immediate-release methylphenidate<br>|
| Active Comparator: Low Intensity BMOD Only<br>Placebo, Low Intensity BMOD | Behavioral: Low-Intensity BMOD<br>* Lower-intensity behavioral treatment package.<br>Drug: Placebo<br> <br> |
| Active Comparator: Low Intensity BMOD + Low Dose Medication<br>0.15 mg/kg MPH, Low Intensity BMOD | Drug: Methylphenidate 0.15 mg/kg<br>* 0.15 m/kg/dose immediate-release methylphenidate<br>Behavioral: Low-Intensity BMOD<br>* Lower-intensity behavioral treatment package.<br>|
| Active Comparator: Low Intensity BMOD + Medium Dose Medication<br>0.3 mg/kg MPH, Low Intensity BMOD | Behavioral: Low-Intensity BMOD<br>* Lower-intensity behavioral treatment package.<br>Drug: Methylphenidate 0.3 mg/kg<br>* 0.3 mg/kg/dose immediate-release methylphenidate<br>|
| Active Comparator: Low Intensity BMOD + Higher Dose Medication<br>0.6 mg/kg MPH, Low Intensity BMOD | Behavioral: Low-Intensity BMOD<br>* Lower-intensity behavioral treatment package.<br>Drug: Methylphenidate 0.6 mg/kg<br>* 0.3 mg/kg/dose immediate-release methylphenidate<br>|
| Active Comparator: High Intensity BMOD Only<br>Placebo, High Intensity BMOD | Behavioral: High Intensity BMOD<br>* Comprehensive high-intensity Summer Treatment Program (STP)<br>|
| Active Comparator: High Intensity BMOD + Low Dose Medication<br>0.15 mg/kg MPH, High Intensity BMOD | Drug: Methylphenidate 0.15 mg/kg<br>* 0.15 m/kg/dose immediate-release methylphenidate<br>Behavioral: High Intensity BMOD<br>* Comprehensive high-intensity Summer Treatment Program (STP)<br>|
| Active Comparator: High Intensity BMOD + Medium Dose Medication<br>0.3 mg/kg MPH, High Intensity BMOD | Drug: Methylphenidate 0.3 mg/kg<br>* 0.3 mg/kg/dose immediate-release methylphenidate<br>Behavioral: High Intensity BMOD<br>* Comprehensive high-intensity Summer Treatment Program (STP)<br>|
| Active Comparator: High Intensity BMOD + Higher Dose Medication<br>0.6 mg/kg MPH, High Intensity BMOD | Drug: Methylphenidate 0.6 mg/kg<br>* 0.3 mg/kg/dose immediate-release methylphenidate<br>Behavioral: High Intensity BMOD<br>* Comprehensive high-intensity Summer Treatment Program (STP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Daily for 45 days | 
| Classroom Behavior | Daily records of percentage of assigned problems completed by children in a 60-minute classroom period. | Daily for 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Satisfaction | Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good). | End of Treatment |