Child/Adolescent Anxiety Multimodal Treatment Study

描述（由申请人提供）：这六个网站的儿童/青少年焦虑多模式治疗研究（CAMS），这是目前在第3年的4年奖的竞争延续，正在提交响应PA-01-123邀请精神疾病的临床研究的合作研究。焦虑症是影响青少年的最常见疾病之一，患病率为12- 20%。三种最常见的儿童期发作的焦虑症，分离焦虑症（SAD），广泛性焦虑症（GAD）和社交恐惧症（SP），通常同时发生，并导致临床上显著的损害，在学术，社会和家庭功能。如果不及时治疗，他们将持续焦虑，严重抑郁和药物滥用到成年。因此，有效的治疗儿童期发作的焦虑症有望减轻，甚至可能防止发病率，甚至死亡率。在随机对照试验中，我们小组的成员已经表明，认知行为疗法（CBT）和选择性5-羟色胺再摄取抑制剂（SSRIs）对青少年焦虑症有效。到目前为止，还没有对照试验将CBT和SSRI单独或联合使用与相同患者人群中的适当对照条件进行比较。CAMS是一项针对7-17岁SAD、SP和GAD青少年的两阶段、盲法、随机对照试验。I期是一项为期12周的急性疗效研究;受试者随机（2：2：2：1）接受CBT、舍曲林、其组合或安慰剂。II期包括I期应答者的6个月维持期。我们采用手动干预和评估方案，包括不良事件评估，以及最先进的质量保证程序，确保研究方案的统一跨中心管理。在所有评估点对所有受试者的有益和不良结局进行评估。评估包括父母、儿童和临床医生评级;为了保持研究盲态，主要结局由盲态独立评估者评估。拟议的竞争性续延是建立在样本征聘和保留方面已证明的可行性基础上的，将CAMS延长24个月，并将CAMS样本从318例受试者扩大到478例受试者，以增加把握度（1）精确估计主要依赖性指标的效应量差异，以及（2）促进亚组差异的识别（调节分析）和治疗反应机制（中介分析）。

DESCRIPTION (provided by applicant): This competing continuation of the six site Child/Adolescent Anxiety Multimodal Treatment Study (CAMS), 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).