NIMH collaborative multimodal treatment study of children with ADHD (MTA): Design, methodology, and protocol evolution

Abstract

The steering committee of the collaborative six-site Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (the MTA) had to develop a common protocol consistent with public health goals and with scientific and clinical state of the art. With the aid of statistical, educational, and public health consultation, the steering committee balanced the stated objectives of the RFA against budgetary, clinical, ethical, and logistical practicalities. Two primary questions will be addressed: (1) What is the relative long-term effectiveness of excellent medication vs. excellent behavioral treatment vs. the combination? (2) What is the relative long-term effective ness of each of these state-of-the art intense treatments vs. routine community care? In a parallel-group design, 576 children (96 at each site) age 7-9 in grades 1-4 are thoroughly assessed in multiple domains from multiple informants and randomized to 4 treatment conditions: a medication-alone strategy, a psychosocial-treatment-alone strategy, a combination strategy, and community comparison (assessment and referral). The first three groups are treated for 14 months and all are re-assessed periodically for 24 months. Each treatment strategy is multi-component, with compromises between clinical flexibility and cross-site uniformity supported by a multi-tiered supervisory/fidelity structure, including 10 manuals, weekly teleconference panels, site visits, circuit-riding consultants, and feedback loops from therapists and supervisors to the steering committee about clinical realities. The resulting data should not only answer the primary questions above, but also support secondary data analyses about the effect of comorbidity, sex, SES, and other subject characteristics on treatment outcome. The MTA should both provide conclusions useful to the practicing clinician and define questions for the next generation of investigations.