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

Florida International University (FIU)

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Placebo; Behavioral: Low-Intensity BMOD; Drug: Methylphenidate 0.15 mg/kg; Drug: Methylphenidate 0.3 mg/kg; Drug: Methylphenidate 0.6 mg/kg; Behavioral: High Intensity BMOD

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00050622

R01MH062946 (U.S. NIH Grant/Contract)

DSIR CT-CT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

154 participants in 12 patient groups, including a placebo group

No Treatment

Placebo Comparator group

Description:

No Medication, No Behavior Modification (BMOD)

Treatment:

Drug: Placebo

Low Dose Medication Only

Active Comparator group

Description:

0.15 mg/kg methylphenidate (MPH), No BMOD

Treatment:

Drug: Methylphenidate 0.15 mg/kg

Medium Dose Medication Only

Active Comparator group

Description:

0.3 mg/kg MPH, No BMOD

Treatment:

Drug: Methylphenidate 0.3 mg/kg

Higher Dose Medication Only

Active Comparator group

Description:

0.6 mg/kg MPH, No BMOD

Treatment:

Drug: Methylphenidate 0.6 mg/kg

Low Intensity BMOD Only

Active Comparator group

Description:

Placebo, Low Intensity BMOD

Treatment:

Drug: Placebo

Behavioral: Low-Intensity BMOD

Low Intensity BMOD + Low Dose Medication

Active Comparator group

Description:

0.15 mg/kg MPH, Low Intensity BMOD

Treatment:

Behavioral: Low-Intensity BMOD

Drug: Methylphenidate 0.15 mg/kg

Low Intensity BMOD + Medium Dose Medication

Active Comparator group

Description:

0.3 mg/kg MPH, Low Intensity BMOD

Treatment:

Drug: Methylphenidate 0.3 mg/kg

Behavioral: Low-Intensity BMOD

Low Intensity BMOD + Higher Dose Medication

Active Comparator group

Description:

0.6 mg/kg MPH, Low Intensity BMOD

Treatment:

Drug: Methylphenidate 0.6 mg/kg

Behavioral: Low-Intensity BMOD

High Intensity BMOD Only

Active Comparator group

Description:

Placebo, High Intensity BMOD

Treatment:

Behavioral: High Intensity BMOD

High Intensity BMOD + Low Dose Medication

Active Comparator group

Description:

0.15 mg/kg MPH, High Intensity BMOD

Treatment:

Drug: Methylphenidate 0.15 mg/kg

Behavioral: High Intensity BMOD

High Intensity BMOD + Medium Dose Medication

Active Comparator group

Description:

0.3 mg/kg MPH, High Intensity BMOD

Treatment:

Drug: Methylphenidate 0.3 mg/kg

Behavioral: High Intensity BMOD

High Intensity BMOD + Higher Dose Medication

Active Comparator group

Description:

0.6 mg/kg MPH, High Intensity BMOD

Treatment:

Drug: Methylphenidate 0.6 mg/kg

Behavioral: High Intensity BMOD