ANXIETY MULTIMODAL STUDY (CAMS)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是加深我们对儿童焦虑症治疗的认识，特别是分离性焦虑症(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方法的重要性。首先，作为一个群体，这些疾病是非常常见的，通常是同时发生的，并与严重的损害相关。其次，这些障碍不仅与儿童时期的不利因素有关，而且如果不加以治疗，相当大一部分受影响的儿童将面临持续到成年的损害。第三，虽然最近的研究证实了CBT和选择性5-羟色胺再摄取抑制剂(SSRI)的益处，但在同一临床人群中，还没有研究将这些治疗及其组合的疗效与控制条件进行比较。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)的有效性提供了证据。然而，不同试验的方法学差异以及缺乏联合治疗细胞限制了临床实践的推广。 通过最初由NIMH儿科精神药理学倡议(RUPP)研究单位建立的合作，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，并解决结果的调解人和调节者的相关问题。七个地点参与了这项试验：杜克大学医学中心；约翰霍普金斯大学医疗机构；纽约大学/NYSPI，坦普尔大学/宾夕法尼亚大学；加州大学洛杉矶分校；以及西方精神病研究所和诊所以及NIMH。 研究目标将通过一项为期六年、多地点、分两个阶段的研究来实现。第一阶段是一项为期12周的随机对照疗效研究，比较SRT、CBT及其组合(COMB)和安慰剂(PBO)在478名初诊为DSM-IV SAD、SP和GAD的儿童中的作用。第二阶段包括为期6个月的治疗维持期，供三种有效治疗的应答者使用。所有受试者，无论反应状态如何，都将在所有预定的评估点进行评估。除了父母、孩子和临床医生的报告外，盲目独立评估者(IE)将评估主要的结果变量。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.