Arnold L E, Abikoff H B, Cantwell D P, Conners C K, Elliott G, Greenhill L L, Hechtman L, Hinshaw S P, Hoza B, Jensen P S, Kraemer H C, March J S, Newcorn J H, Pelham W E, Richters J E, Schiller E, Severe J B, Swanson J M, Vereen D, Wells K C
Child and Adolescent Disorders Research Branch, National Institute of Mental Health, Rockville, MD 20857, USA.
Arch Gen Psychiatry. 1997 Sep;54(9):865-70. doi: 10.1001/archpsyc.1997.01830210113015.
The Collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (ADHD), the MTA, is the first child multisite cooperative agreement treatment study of children conducted by the National Institute of Mental Health, Rockville, Md. It examines the long-term effectiveness of medication vs behavioral treatment vs both for treatment of ADHD and compares state-of-the-art treatment with routine community care. In a parallel-groups design, 576 children (age, 7-9 years) with ADHD (96 at each site) are thoroughly assessed and randomized to 4 conditions: (1) medication alone, (2) psychosocial treatment alone, (3) the combination of both, (4) or community comparison. The first 3 groups are treated for 14 months and all are reassessed periodically for 24 months. Designers met the following challenges: framing clinically relevant primary questions; defining the target population; choice, intensity, and integration and combination of treatments for fair comparisons; combining scientific controls and standardization with clinical flexibility; and implementing a controlled clinical trial in a nonclinical setting (school) controlled by others. Innovative solutions included extensive decision algorithms and manualized adaptations of treatments to specific needs.
注意力缺陷多动障碍(ADHD)儿童协作多模式治疗研究(MTA)是美国国立精神卫生研究所(位于马里兰州罗克维尔)开展的首个针对儿童的多中心合作协议治疗研究。该研究考察药物治疗、行为治疗以及两者结合治疗ADHD的长期效果,并将最先进的治疗方法与常规社区护理进行比较。在平行组设计中,576名患有ADHD的儿童(年龄7至9岁,每个研究点96名)接受全面评估,并随机分配到4种治疗条件下:(1)仅药物治疗;(2)仅心理社会治疗;(3)两者结合;(4)社区对照。前3组接受14个月的治疗,所有儿童在24个月内定期接受重新评估。研究设计者面临以下挑战:提出临床相关的主要问题;界定目标人群;选择、确定治疗强度以及整合和组合治疗方法以进行公平比较;将科学对照和标准化与临床灵活性相结合;以及在由他人控制的非临床环境(学校)中开展对照临床试验。创新的解决方案包括广泛的决策算法以及根据特定需求对治疗方法进行手册化调整。