ANXIETY MULTIMODAL STUDY (CAMS)

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 本研究的目的是进一步了解儿童焦虑症的治疗，特别是分离焦虑症（SAD），社交恐惧症（SP）和广泛性焦虑症（GAD）。几个考虑因素有助于评估这些疾病的治疗的重要性。首先，作为一个群体，这些疾病是非常常见的，通常共同发生，并与严重的损害。第二，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，很大一部分受影响的儿童将面临长期的损害，一直延续到成年。第三，虽然最近的研究确立了CBT和选择性5-羟色胺再摄取抑制剂（SSRIs）的益处，但没有研究比较这些治疗及其组合在相同临床人群中与对照条件的疗效。我们小组成员的研究为CBT和选择性5-羟色胺再摄取抑制剂（SSRIs）的疗效提供了证据。然而，不同试验的方法学差异和缺乏联合治疗单元限制了临床实践的普遍性。 通过最初由NIMH儿科精神药理学研究单位（RUPP）培养的合作，我们提出了一项多中心随机对照试验，以复制和扩展精神药理学和CBT文献的初步发现，并解决结果的介导者和调节者的相关问题。本试验涉及七个研究中心：杜克大学医学中心、约翰霍普金斯医疗机构、纽约大学/纽约SPI、坦普尔大学/宾夕法尼亚大学、加州大学洛杉矶分校、西部精神病研究所和诊所以及NIMH。 研究目标将通过一项为期6年的多中心2期研究来实现。I期是一项为期12周的随机对照疗效研究，在478名主要诊断为DSM-IV SAD、SP和GAD的儿童（年龄7 - 17岁）中比较SRT、CBT及其组合（COMB）与安慰剂（PBO）。II期包括针对三种活性治疗的应答者的6个月治疗维持期。将在所有计划的评估时间点对所有受试者（无论缓解状态如何）进行评价。除父母、儿童和临床医生报告外，盲态独立评价者（IE）将评估主要结局变量。除了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中心管理。

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.