N/A
N=154
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT00050622 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Social Behavior-Negative Verbalizations — 73.32; 45.41; 28.41; 15.08 Number of Observed Behaviors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methylphenidate 0.15 mg/kg (Drug); Low-Intensity BMOD (Behavioral); Methylphenidate 0.3 mg/kg (Drug); Placebo (Drug); Methylphenidate 0.6 mg/kg (Drug); High Intensity BMOD (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Aug 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Social Behavior-Negative Verbalizations |
73.32; 45.41; 28.41; 15.08; 27.06; 13.70 | — |
| PRIMARY Classroom Behavior |
37; 53; 57; 61; 53; 67 | — |
| SECONDARY Treatment Satisfaction |
1.8; 2.7; 3.8; 3.5; 4.6; 5.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00050622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.