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Development and implementation of multimodal and combined treatment studies in children and adolescents: NIMH perspectives.

Over the last decade, combined psychosocial and pharmacologic treatment studies have been marked by increasing methodologic sophistication and complexity. While the design and implementation of such studies with adults is difficult, even more levels of complexity must be faced by investigators who develop such studies with children. This paper reviews the rationale, background, and design considerations related to the development and implementation of such studies. In particular, issues related to the choice of particular treatment combinations, subject selection strategies, and assessment approaches are discussed. Because most childhood conditions have complex roots lying both in biological and psychosocial phenomena, greater use of multimodal treatment research approaches will be critical to advance the field of child and adolescent treatment research. Recommendations are outlined for future study designs for child and adolescent treatment trials.