Child/Adolescent Anxiety Multimodal Treatment Study

描述(由申请人提供)：这是六个站点的儿童/青少年焦虑多模式治疗研究(CAMS，U01MH64092)的竞争性延续，目前处于四年奖的第三年，是应PA-01-123邀请精神疾病临床研究的合作研究而提交的。焦虑症是影响年轻人的最常见的疾病之一，点患病率为12%-20%。儿童时期最常见的三种焦虑症，分离焦虑症(SAD)、广泛性焦虑症(GAD)和社交恐惧症(SP)，通常是同时发生的，并在临床上造成显著的学习、社会和家庭功能障碍。如果不进行治疗，它们预示着持续的焦虑、严重的抑郁和药物滥用，直到成年。因此，对儿童期焦虑症的有效治疗有望缓解甚至预防发病率甚至死亡率。在随机对照试验中，我们小组的成员已经证明认知行为疗法(CBT)和选择性5-羟色胺再摄取抑制剂(SSRI)对青少年焦虑症有效。到目前为止，还没有在同一患者群体中将CBT和SSRI单独或联合与合适的对照条件进行比较的对照试验。CAMS是一项针对7-17岁患有SAD、SP和GAD的青年的两阶段、掩蔽、随机对照试验。第一阶段是一项为期12周的急性疗效研究；受试者随机(2：2：2：1)接受CBT、舍曲林、它们的组合或服用安慰剂。第二阶段包括对第一阶段应答者进行为期6个月的维护阶段。我们采用手动干预和评估方案，包括不良事件的评估，以及最先进的质量保证程序，以确保研究方案的统一跨站点管理。所有受试者都会在所有评估点接受有益和不利结果的评估。评估包括父母、孩子和临床医生的评分；为了保持研究的盲目性，主要结果由盲目的独立评估者评估。拟议的竞争性延续建立在样本招募和保留的可行性基础上，将把CAMS延长24个月，并将CAMS样本从318人扩大到478人，以增加以下能力：(1)准确估计主要依赖措施的影响大小差异；(2)促进确定分组差异(主持人分析)和治疗反应机制(调解人分析)。

DESCRIPTION (provided by applicant): This competing continuation of the six site Child/Adolescent Anxiety Multimodal Treatment Study (CAMS, U01MH64092), which is currently in year 3 of the 4 year award, is being submitted in response to PA-01-123 inviting collaborative research on Clinical Studies of Mental Disorders. Anxiety disorders are among the most common conditions affecting youth with point prevalence of 12-20%. The three most common childhood onset anxiety disorders, separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SP), routinely co-occur and cause clinically significant impairment in academic, social, and family functioning. Left untreated, they foretell persistent anxiety, major depression and substance abuse into adulthood. Hence, effective treatments for childhood-onset anxiety disorders promise to alleviate and perhaps to prevent morbidity and even mortality. In randomized controlled trials, members of our group have shown that cognitive-behavioral therapy (CBT) and the selective serotonin reuptake inhibitors (SSRIs) are effective for anxiety disorders in youth. To date there are no controlled trails comparing CBT and an SSRI, alone and in combination, to a suitable control condition in the same patient population. CAMS is a two phase, masked, randomized controlled trial for youth ages 7-17 years with SAD, SP and GAD. Phase I is a 12-week, acute efficacy study; subjects are randomized (2:2:2:1) to CBT, sertraline, their combination or pill placebo. Phase II involves a 6-month maintenance phase for Phase I responders. We employ manualized intervention and assessment protocols, including the assessment of adverse events, and state-of-the-art quality assurance procedures that insure uniform cross-site administration of the study protocol. All subjects are evaluated at all assessment points for both beneficial and adverse outcomes. Assessments include parent, child and clinician ratings; to preserve study blindness, the primary outcomes are assessed by blind independent evaluators. The proposed competing continuation, which builds on demonstrated feasibility in sample recruitment and retention, will extend CAMS for 24 months and expand the CAMS sample from 318 to 478 subjects to increase power (1) to precisely estimate effect size differences on the primary dependent measures and (2) to promote the identification of subgroup differences (moderator analyses) and mechanisms of treatment response (mediator analyses).