2/3 Treatment of Anxiety in Autism Spectrum Disorder

描述（由申请人提供）：自闭症谱系障碍（ASD）是一种常见的神经发育综合征，影响1%的美国儿童。共病焦虑障碍影响40%至50%的ASD儿童，导致严重的痛苦和损害，超过单独的ASD。高度焦虑与ASD症状的严重程度增加和受影响青年的社会适应不良有关。此外，自闭症儿童的父母认为与焦虑有关的问题是他们的孩子面临的两大挑战之一。[虽然标准实践认知行为疗法（CBT）已被确立为典型发育中的青少年焦虑症的有效和安全的治疗方法，但其在ASD共病病例中的效用仍然未知。到目前为止，还没有研究通过实验将标准实践CBT与针对患有焦虑和ASD共病的儿童进行个性化的认知行为干预进行比较。文献中的这一差距特别令人担忧，因为对于患有ASD和共病焦虑的青少年没有药物支持的治疗选择，并且现有的药物干预可能具有一些缺点（例如，在该人群中的疗效有限，副作用和药物治疗的潜力 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ASD焦虑的个性化CBT（自闭症儿童焦虑行为干预：BIACA）相对于焦虑的标准实践CBT（应对猫计划）的疗效。在过去的五年里，拟议的BIACA干预措施已经适应并适应了高功能ASD儿童的特点和需求;应对猫计划反映了在多个NIH资助的试验中得到经验支持的社区标准。为了响应NIH的路线图倡议，BIACA采用了模块化治疗方法，使干预措施能够个性化，以满足每个青少年的独特需求。[Thus，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功效，（2）评估治疗收益的维持，（3）检查个性化干预对功能结果如社会反应、孤独和友谊质量的影响，（4）测试自闭症严重程度作为治疗结果的调节剂，和（5）探索治疗结果的其他调节剂和介质。]共有180名患有ASD和并发焦虑症的青少年（年龄8-13岁）将被随机分配到两种治疗条件之一。这项研究的三个招募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。USF将提供数据管理服务。考虑到越来越多的儿童被诊断患有ASD以及共病焦虑的频率和严重程度，拟议的工作是针对ASD青少年的独特需求而设计的，并将为公共卫生工作做出及时的贡献。

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.