ANXIETY MULTIMODAL STUDY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是进一步了解儿童焦虑症的治疗方法，特别是分离焦虑症（SAD）、社交恐惧症（SP）和广泛性焦虑症（GAD）。有几方面的考虑有助于评估这些疾病治疗的重要性。首先，作为一个群体，这些疾病非常常见，通常同时发生，并伴有严重的损害。其次，这些疾病不仅与儿童时期的不利条件有关，而且如果不加以治疗，很大一部分受影响儿童将面临长期损害，直至成年。第三，虽然最近的研究证实了CBT和选择性血清素再摄取抑制剂（SSRIs）的益处，但没有研究比较这些治疗方法及其联合治疗在同一临床人群对照条件下的疗效。我们小组成员的研究为CBT和选择性血清素再摄取抑制剂（SSRIs）的有效性提供了证据。然而，不同试验的方法差异和联合治疗细胞的缺乏限制了临床实践的推广。通过NIMH儿童精神药理学倡议研究单位（RUPP）最初建立的合作，我们提出了一项多地点随机对照试验，以复制和扩展精神药理学和CBT文献的初步发现，并解决结果的中介和调节因素的相关问题。七个地点参与了这项试验：杜克大学医学中心；约翰霍普金斯医疗机构；纽约大学/NYSPI，天普大学/宾夕法尼亚大学；加州大学洛杉矶分校；西方精神病学研究所和诊所以及NIMH。研究目标将通过一项为期6年、多地点、两阶段的研究来实现。第一阶段是一项为期12周的随机对照疗效研究，比较了SRT， CBT及其联合（COMB）与药丸安慰剂（PBO）在478名患有DSM-IV SAD， SP和GAD的儿童（7-17岁）中的疗效。II期包括对三种积极治疗有反应的患者的6个月治疗维持期。无论反应状态如何，所有受试者都将在所有计划的评估点进行评估。除了家长、儿童和临床医生的报告外，盲独立评估者（IE）将评估主要结果变量。除了采用最先进的干预方案外，还采用了质量保证和不良事件监测程序，以确保方案的统一跨站点管理。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of the proposed study is to further our knowledge of the treatment of childhood anxiety disorders, specifically separation anxiety disorder (SAD), social phobia (SP) and generalized anxiety disorder (GAD). Several considerations contribute to the importance of evaluating treatments for these disorders. First, as a group, these disorders are exceedingly common, typically co-occur and are associated with serious impairment. Second, not only are the disorders associated with disadvantage during childhood, but also if untreated, a significant proportion of affected children face prolonged impairment extending into adulthood. Third, while recent studies establish the benefits of both CBT and selective serotonin re-uptake inhibitors (SSRIs), there are no studies comparing the efficacy of these treatments and their combination against a control condition in the same clinical population. Studies by members of our group provide evidence for the efficacy of CBT and the selective serotonin reuptake inhibitors (SSRIs). However, methodological differences across trials and the absence of a combination treatment cell limit generalizability to clinical practice. Through established collaborations initially fostered by the NIMH Research Units of Pediatric Psychopharmacology initiative (RUPP), we propose a multi-site randomized controlled trial to replicate and extend the initial findings from the psychopharmacology and CBT literatures, and to address related questions of mediators and moderators of outcome. Seven sites are involved in this trial: Duke University Medical Center; Johns Hopkins Medical Institutions; NYU/NYSPI, Temple University/U Penn; University of California at Los Angeles; and Western Psychiatric Institute and Clinic and the NIMH. The study goals will be addressed through a six-year, multisite, 2-phase study. Phase I is a 12-week randomized controlled efficacy study comparing SRT, CBT, their combination (COMB), with pill placebo (PBO) in 478 children (ages 7-17 years) with primary diagnoses of DSM-IV SAD, SP, and GAD. Phase II involves a 6-month treatment maintenance period for responders to the three active treatments. All subjects regardless of response status will be evaluated at all scheduled assessment points. In addition to parent, child, and clinician report, blind Independent Evaluators (IE) will assess the primary outcome variables. Besides state-of-the art intervention protocols, quality assurance and adverse event monitoring procedures are employed to insure uniform cross-site administration of the protocol.