Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD
Brief summary
This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
Detailed description
Young children age 3-5.5 years will be studied. The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. Participants will be monitored by regular visits with a study physician. Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring
Interventions
DRUGMethylphenidate
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
Boys and girls who are: * Between the ages of 3-5.5 years * Qualified as having ADHD by our diagnostic evaluations and clinical staff * Otherwise generally healthy * Willing, and have parents that are willing, to attend all visits required by the study * Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week * In classrooms with teachers that are willing to participate by completing rating scale
Countries
United States
Outcome results
None listed