1/3 Treatment of Anxiety in Autism Spectrum Disorder

描述(由申请人提供)：自闭症谱系障碍(ASD)是常见的神经发育综合征，影响1%的美国儿童。共患焦虑症的自闭症儿童中有40%到50%受到影响，在自闭症单独造成的基础上，还会造成巨大的痛苦和损害。在受影响的年轻人中，高度焦虑与自闭症症状和社交失调的严重程度有关。此外，患有自闭症儿童的父母认为与焦虑相关的问题是他们的孩子面临的两个最大挑战之一。[虽然认知行为疗法(CBT)的标准做法已经被证实是治疗典型发育中的青少年焦虑症的一种有效和安全的治疗方法，但它在ASD合并病例中的有效性仍不清楚。到目前为止，还没有研究将标准的CBT与认知行为干预进行实验比较，这种干预已经针对患有焦虑和自闭症的儿童进行了个性化。]文献中的这一差距特别令人担忧，因为对于患有自闭症和共病焦虑的年轻人，没有经验支持的治疗选择，而且现有的药物干预可能有一些缺点(例如，在这一人群中疗效有限，副作用，以及潜在的药物治疗 X药物相互作用)。[因此，我们建议在三个治疗地点进行一项随机对照试验，以评估个性化CBT治疗自闭症儿童焦虑(行为干预：BIACA)与标准CBT治疗焦虑(应对猫计划)的疗效。在过去五年中，建议的BIACA干预措施已针对高功能自闭症儿童的特征和需求进行了调整和量身定做；应对猫计划反映了在NIH资助的多项试验中得到经验支持的社区标准。]为了响应NIH路线图倡议，BIACA采用了模块化治疗方法，允许根据每个青少年的独特需求进行个性化干预。[因此，拟议的研究将：(1)检查BIACA相对于代表标准实践治疗的应对猫的有效性，(2)评估治疗成果的维持，(3)检查个性化干预对社会反应性、孤独感和友谊质量等功能结果的影响，(4)测试自闭症严重程度作为治疗结果的调节因素，以及(5)探索治疗结果的其他调节因素和中介。]总共180名患有自闭症和共生焦虑的青年(8-13岁)将被随机分配到两种治疗条件中的一种。这项研究的三个招聘地点是加州大学洛杉矶分校、南佛罗里达大学(USF)和坦普尔大学。美国联邦将提供数据管理服务。考虑到被诊断为自闭症的儿童人数不断增加，以及共病焦虑的频率和严重程度，拟议的工作是为患有自闭症的青少年的独特需求量身定做的，并将及时为公共卫生努力做出贡献。

DESCRIPTION (provided by applicant): Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. High anxiety is associated with increased severity of ASD symptoms and social maladjustment in affected youth. Further, parents of children with ASD consider anxiety-related problems to be among the top two challenges facing their children. [Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD.] This gap in the literature is of particular concern because there are no empirically-supported treatment options for youth with ASD and comorbid anxiety, and existing pharmacological interventions may have some disadvantages (e.g., limited efficacy in this population, side effects, and potential for drug x drug interactions). [Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Over the last five years, the proposed BIACA intervention has been adapted and tailored to the characteristics and needs of high-functioning children with ASD; the Coping Cat program reflects the community standard that has been empirically supported in multiple NIH-funded trials.] In response to the NIH Roadmap Initiative, BIACA employs a modular treatment approach, allowing the intervention to be personalized to each youngster's unique needs. [Thus, the proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes such as social responsiveness, loneliness, and friendship quality, (4) test autism severity as a moderator of treatment outcome, and (5) explore other moderators and mediators of treatment outcome.] A total of 180 youth (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the two treatment conditions. The three recruitment sites for this study are UCLA, the University of South Florida (USF), and Temple University. USF will provide data management services. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.