Design and rationale of controlled study of long-term methylphenidate and multimodal psychosocial treatment in children with ADHD.

OBJECTIVE: To describe the rationale, methodology, and sample characteristics of a dual-site treatment study (New York and Montreal) of children with attention-deficit/hyperactivity disorder (ADHD) conducted between 1990 and 1995. The hypotheses were that (1) methylphenidate combined with comprehensive multimodal psychosocial treatment was superior to methylphenidate alone in improving multiple functions and (2) the efficacy of the psychosocial intervention resulted from its specific components and not from nonspecific treatment effects.
METHOD: One hundred three children with ADHD (ages 7-9), free of conduct and learning disorders, who responded to methylphenidate, were randomized for 2 years to (1) methylphenidate treatment alone; (2) methylphenidate combined with multimodal psychosocial treatment that included parent training and counseling, academic assistance, psychotherapy, and social skills training; or (3) methylphenidate plus attention control treatment that excluded specific aspects of the psychosocial intervention. Children were switched to single-blind placebo after 12 months; methylphenidate was reinstituted when clinically indicated. Assessments included ratings by parents, teachers, children, and psychiatrists; school observations in academic and gym classes; and academic performance tests. Almost 80% of families completed the 2-year study. Companion papers present treatment effects.
CONCLUSIONS: A comprehensive 2-year psychosocial treatment was delivered successfully to children with ADHD and their families. Copyright 2004 American Academy of Child and Adolescent Psychiatry

RCT Entities:   Population Interventions Outcomes