Child/Adolescent Anxiety Multimodal Treatment Study

描述（由申请人提供）：点患病率估计值范围为 从12%到20%，焦虑症是最常见的 影响儿童和青少年的状况。最常见的三种 损害儿童期发作的焦虑症是分离焦虑症， 社交恐惧症和广泛性焦虑症。作为一个群体， 通常同时发生并导致临床显著的痛苦和损害 影响学校社会和家庭功能如果不治疗，这些 疾病使儿童有患焦虑症、严重抑郁症的风险， 在某些情况下，药物滥用延续到青春期后期和成年期。 因此，儿童期发作的焦虑症的有效治疗有望 减轻并可能防止长期发病率甚至死亡率。在 随机对照试验，我们已经表明，两种单一疗法， 认知行为疗法（CBT）和选择性5-羟色胺再摄取 抑制剂（SSRI），氟伏沙明（FLV），是有效治疗分离 儿童焦虑症、社交恐惧症和广泛性焦虑症， 青少年。即使单一疗法有效， 的患者在治疗后仍有症状， 综合治疗。目前还没有系统的对照研究 将单独或组合的CBT和SSRI与对照条件进行比较 在相同的患者群体中。这一修订后的申请提出了一个为期四年， 比较认知行为（CBT）和药物治疗7 - 16岁青少年焦虑症的6个地点、随机对照疗效试验 紊乱1期是一项为期12周、随机分配的急性疗效研究 比较CBT、FLV、它们的组合（每种条件n=90）和药丸安慰剂 对照组（n=48），318例（53例/研究中心），DSM-IV主要诊断为 分离焦虑症、社交恐惧症和/或广泛性焦虑症。相 II期涉及I期应答者的6个月治疗维持期。所有 无论缓解状态如何，受试者将在所有计划的 评估点。除了全面的父母，孩子，临床医生， 教师报告，主要结果变量将由盲法评估 独立评估员。人工干预和评估方案，加上 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中心给药。

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.