Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)

New York State Psychiatric Institute

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Methylphenidate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00018863

U01MH060833 (U.S. NIH Grant/Contract)

U01MH060903 (U.S. NIH Grant/Contract)

DSIR CT-M2

U01MH060943 (U.S. NIH Grant/Contract)

U01MH060642 (U.S. NIH Grant/Contract)

U01MH060848 (U.S. NIH Grant/Contract)

#3761

U01MH060900 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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