Child/Adolescent Anxiety Multimodal Treatment Study

描述（由申请人提供）：这是六点儿童/青少年焦虑多模式治疗研究（CAMS）的竞争延续，目前处于四年奖的第三年，正在响应PA-01-123邀请精神障碍临床研究的合作研究。焦虑症是影响青年的最常见疾病之一，点患病率为12-20%。三种最常见的儿童期焦虑障碍：分离性焦虑障碍（SAD）、广泛性焦虑障碍（GAD）和社交恐惧症（SP），通常会共同发生，并导致学业、社交和家庭功能的临床显著损害。如果不及时治疗，它们预示着持续的焦虑、严重的抑郁和成年后的药物滥用。因此，对儿童期焦虑症的有效治疗有望减轻甚至可能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表明，认知行为疗法（CBT）和选择性血清素再摄取抑制剂（SSRIs）对青少年焦虑症有效。迄今为止，还没有对照试验将CBT和SSRI单独或联合用于同一患者群体中合适的对照条件。CAMS是一项针对7-17岁患有SAD、SP和GAD的青少年的两期、蒙面、随机对照试验。I期是一个为期12周的急性疗效研究；受试者随机（2:2:2:1）接受CBT、舍曲林、其联合用药或安慰剂治疗。II期包括针对I期应答者的6个月的维持期。我们采用人工干预和评估方案，包括不良事件评估和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。在所有评估点对所有受试者进行有益和不良结果的评估。评估包括家长、儿童和临床医生评分；为了保持研究的盲性，主要结果由独立的盲评者评估。拟议的竞争延续，建立在样本招募和保留的可行性基础上，将CAMS延长24个月，并将CAMS样本从318个扩展到478个受试者，以增加(1)精确估计主要依赖措施的效应大小差异，(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).