Child/Adolescent Anxiety Multimodal Treatment Study

儿童/青少年焦虑多模式治疗研究

• 批准号: 6663709
• 负责人: John C. Piacentini
• 金额: $ 38.01万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6663709
• 关键词: adolescence (12-20); antidepressants; anxiety disorders; behavioral /social science research tag; clinical research; clinical trials; cognitive behavior therapy; combination therapy; cooperative study; fluvoxamine; functional ability; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; middle childhood (6-11); patient oriented research; psychopharmacology; psychotherapy; serotonin inhibitor

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.

描述（由申请人提供）：范围内的点流行估计值 从12％到20％，焦虑症是最常见的 影响儿童和青少年的条件。最常见的三个 损害儿童期焦虑症是分离焦虑症， 社会恐惧症和普遍焦虑症。作为一个小组，这些疾病 经常同时发生并造成临床上的严重困扰和障碍 影响学校，社交和家庭功能。这些，这些，这些 疾病使儿童处于焦虑症，严重抑郁症以及 在某些情况下，滥用药物延长到青春期和成年期。 因此，有效治疗儿童期焦虑症有望 减轻，也许可以防止长期发病率甚至死亡率。在 随机对照试验，我们已经证明了两个单一疗法， 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）是分离的有效治疗方法 儿童的焦虑，社交恐惧症和普遍的焦虑症 青少年。即使单层是有效的 治疗后的患者仍然有症状，可能会受益 从合并治疗。尚无系统的，对照研究 将CBT和SSRI单独或组合比较与对照条件 在同一患者人群中。该修订的申请提议为期四年， 六个站点，随机对照疗效试验比较了7至16岁的年轻人的认知行为（CBT）和药理学治疗 疾病。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）和药丸安慰剂 在318（53/站点）DSM-IV主要诊断的年轻人中对照（n = 48） 分离焦虑，社交恐惧症和/或普遍的焦虑症。阶段 II涉及I期响应者的6个月治疗维持期。全部 主题不管响应状态如何评估 评估点。除了全面的父母，孩子，临床医生和 教师报告，主要结果变量将由盲人评估 独立评估者。手动干预和评估协议加上 最先进的质量保证和不利事件监控程序 确保研究方案的统一跨站点给药。