Child /adolescent anxiety multimodal treatment study

描述（由申请人提供）：点患病率估计范围 从 12% 到 20%，焦虑症是最常见的疾病之一 影响儿童和青少年的状况。最常见的三种 损害儿童期发病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，这些疾病 通常同时发生并导致临床上显着的痛苦和损害 影响学校、社会和家庭的运作。如果不加以治疗，这些 疾病使儿童面临焦虑症、重度抑郁症的风险， 在某些情况下，药物滥用会持续到青春期后期和成年期。 因此，针对儿童期发作的焦虑症的有效治疗有望 减轻甚至预防长期发病甚至死亡。在 随机对照试验，我们已经证明两种单一疗法， 认知行为疗法（CBT）和选择性血清素再摄取 抑制剂（SSRI）、氟伏沙明（FLV）是有效的分离治疗方法 儿童的焦虑症、社交恐惧症和广泛性焦虑症 青少年。尽管单一疗法对相当多的患者有效 的患者在治疗后仍然有症状，并且可能会受益 来自综合治疗。目前还没有系统的、对照的研究 将 CBT 和 SSRI 单独或组合与对照条件进行比较 在同一患者群体中。该修订后的申请提出了为期四年的 比较认知行为的六中心随机对照疗效试验 针对 7 至 16 岁青少年焦虑症的 CBT 和药物治疗 失调。第 1 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）和药物安慰剂 在 318 名（53 名/中心）青少年中进行对照（n=48），患有 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。阶段 II 期涉及 I 期反应者 6 个月的治疗维持期。全部 无论响应状态如何，受试者都将在所有预定的时间进行评估 评估点。除了全面的家长、孩子、临床医生和 老师报告，主要结果变量将通过盲法评估 独立评估员。手动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.