Child /adolescent anxiety multimodal treatment study

描述(由申请人提供)：估计患病率的范围为 从12%到20%，焦虑症是最常见的 影响儿童和青少年的疾病。最常见的三个 儿童期出现的焦虑症是分离性焦虑症， 社交恐惧症和广泛性焦虑症。作为一个群体，这些障碍 例行公事地同时发生并引起临床上显著的痛苦和损害 影响学校、社会和家庭的功能。如果不治疗，这些人 精神障碍使儿童面临患焦虑症、严重抑郁症的风险， 在某些情况下，药物滥用会延伸到青春期后期和成年期。 因此，对儿童期焦虑症的有效治疗有望 缓解，也许是为了防止长期的发病率甚至死亡率。在……里面 随机对照试验，我们已经证明了两种单一疗法， 认知行为疗法与选择性5-羟色胺再摄取 抑制剂(SSRI)、氟伏沙明(FLV)是有效的分离处理方法 儿童焦虑、社交恐惧症和广泛性焦虑症 青少年。即使单一疗法是有效的，也有相当多的人 %的患者在治疗后仍有症状，并可能受益 来自综合治疗。到目前为止还没有系统的对照研究。 将CBT和SSRI单独或组合与控制条件进行比较 在相同的患者群体中。这份修订后的申请提出了为期四年的 六个地点的随机对照疗效试验，比较认知-行为 7-16岁青少年焦虑症的CBT和药物治疗 精神错乱。第一阶段是一项为期12周的随机分配急性疗效研究，比较CBT、FLV、它们的组合(n=90，每种情况)和服用安慰剂 对照(n=48)318名患有DSM-IV的青年(53个/站点)，初步诊断为 分离焦虑、社交恐惧症和/或广泛性焦虑症。阶段 第二阶段涉及对第一阶段应答者为期6个月的治疗维持期。全 无论响应状态如何，都将在所有预定时间对受试者进行评估 评估分数。除了全面的家长、孩子、临床医生和 老师报告说，主要的结果变量将由盲人评估 独立评估者。手动干预和评估方案以及 最先进的质量保证和不良事件监测程序 确保研究方案的统一跨站点管理。

DESCRIPTION (provided by applicant): With point prevalence estimates ranging from 12 percent to 20 percent, anxiety disorders are among the most common conditions affecting children and adolescents. The three most commonly impairing childhood-onset anxiety disorders are separation anxiety disorder, social phobia and generalized anxiety disorder. As a group, these disorders routinely co-occur and cause clinically significant distress and impairment affecting school, social, and family functioning. Left untreated, these disorders leave children at risk for anxiety disorders, major depression and, in some cases, substance abuse extending into late adolescence and adulthood. Hence, effective treatments for childhood-onset anxiety disorders promise to alleviate and perhaps to prevent long-term morbidity and even mortality. In randomized controlled trials, we have shown that two monotherapies, cognitive-behavioral therapy (CBT) and the selective serotonin reuptake inhibitor (SSRI), fluvoxamine (FLV), are effective treatments for separation anxiety, social phobia, and generalized anxiety disorders in children and adolescents. Even though the monotherapies are effective a substantial number of patients remain symptomatic following treatment and, might have benefited from combined treatment. There are as yet no systematic, controlled studies comparing CBT and an SSRI, alone or in combination, against a control condition in the same patient population. This revised application proposes a four-year, six site, randomized controlled efficacy trial comparing cognitive-behavioral (CBT) and pharmacological treatment for youth ages 7 to 16 years with anxiety disorders. Phase 1 is a 12-week, random assignment acute efficacy study comparing CBT, FLV, their combination (n=90, each condition), and pill placebo control (n=48) in 318 (53/site) youth with DSM-IV primary diagnoses of separation anxiety, social phobia, and/or generalized anxiety disorder. Phase II involves a 6-month treatment maintenance period for Phase I responders. All subjects regardless of response status will be evaluated at all scheduled assessment points. In addition to comprehensive parent, child, clinician, and teacher reports, the primary outcome variables will be assessed by blind independent evaluators. Manualized intervention and assessment protocols plus state-of-the-art quality assurance and adverse event monitoring procedures insure uniform cross-site administration of the study protocol.