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Crossover randomised controlled trial (titration phase) followed by parallel group randomised controlled trial (efficacy phase).
Five weeks for titration phase and 4 weeks for efficacy phase.
Six academic sites, USA; enrolment February 2001 to April 2003.
Titration phase: 165 children aged 3–5.5 years with DSM-IV attention deficit/hyperactivity disorder (ADHD) of the predominantly hyperactive or combined subtypes (Revised Conners Parent and Teacher Rating Scale hyperactive-impulsive subscale T score of 65). Efficacy phase: 114 children completing the titration phase. Exclusions: previous stimulant treatment; intolerance to methylphenidate; Children’s Global Assessment Scale impairment score ⩾50; different primary caregiver over past 6 months; Full Scale IQ score equivalent of ⩽70 on the Differential Ability Scales; less than …
For correspondence: Dr Laurence Greenhill, Division of Child and Adolescent Psychiatry, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA;
Sources of funding: National Institute of Mental Health, University of California Irvine, Duke University Medical Center, NYSPI/Columbia University, New York University Child Study Centre, University of California Los Angeles, Johns Hopkins University.