2/3 CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents

描述(由申请人提供)：自闭症谱系障碍(ASD)在美国大约每150名儿童和青少年中就有1名受到影响，使其成为最常见的神经生物学疾病之一。多达80%的患有自闭症的年轻人会受到共患焦虑症的影响，这会造成严重的痛苦和损害，而不仅仅是自闭症的诊断。虽然认知行为疗法(CBT)已被确立为典型发育中青少年焦虑症的黄金标准治疗方法，研究团队的创新工作支持了其在患有自闭症和共病焦虑的儿童中的实用价值，但尚不存在针对患有自闭症和共病焦虑症的早期青少年的方案。事实上，对于患有自闭症和共病焦虑症的早期青少年，没有经验支持的治疗选择；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x药物相互作用)。因此，我们建议开发一种针对青春期早期焦虑和共病ASD的CBT方案，以及一种可信的比较方案(松弛训练；RT)，用于未来的多点临床试验，以测试CBT在这一人群中的疗效。为了响应复苏法案的有限竞争，每个站点将雇用和培训至少三名新的研究人员来进行这项研究。最初的方案开发工作将侧重于调整针对患有自闭症和共病焦虑的较小儿童的有效CBT计划中的相关治疗元素，以适应早期青少年的特征和临床需求。然后将添加适合发育的新的治疗成分。现有的RT治疗方案也将被修改，用于患有ASD的早期青少年。作为对国家卫生研究院路线图倡议的回应，将注意议定书的适应性，并提供不同的介绍。治疗完整性和能力的措施将与协议一起制定。此后，我们将通过我们治疗18名患有自闭症和共病焦虑症的青少年(11-14岁)的经验以及通过临床医生、患者和专家的反馈来完善方案和措施的制定。然后，将在一项试点研究的背景下审查实施这两种方案的可行性，该研究纳入了计划中的未来疗效试验的所有特征，比较了CBT和RT，但样本量有限(N=48)。在项目结束时，将完成完善的治疗手册，最后确定诚信和能力措施，并测试其可靠性和有效性，三个招聘地点将制定促进和评估各地点提供治疗和评估程序的一致性的协议，并将编写一份与R01挂钩的赠款，以测试CBT的疗效。这项研究的三个招聘地点是加州大学洛杉矶分校(UCLA)、南佛罗里达大学和迈阿密大学。加州大学洛杉矶分校神经精神病学(SEMEL)研究所的生物统计核心将提供数据管理服务。考虑到越来越多的年轻人被诊断为ASD，而那些患有共病焦虑的青少年缺乏经验支持的治疗选择，我们提出的旨在制定有效的CBT方案的工作将及时为公共卫生努力做出贡献。 公共卫生相关性：多达80%患有自闭症谱系障碍的年轻人患有共病焦虑症，除了自闭症谱系诊断之外，还会造成巨大的痛苦和损害。认知行为疗法(CBT)是典型的青春期焦虑症患者的黄金标准治疗方法，但尚未适应患有自闭症和焦虑症的青少年的独特需求。随着越来越多的青少年在儿童早期之后被诊断出患有自闭症，这样的治疗方案可以有助于公共卫生努力，以满足患有自闭症的早期青少年的心理健康需求。

DESCRIPTION (provided by applicant): Autism spectrum disorders (ASD) affect approximately 1 out of 150 children and adolescents in the United States, making them one of the most common neurobiological conditions. Comorbid anxiety disorders affect as many as 80% of youth with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) has been established as the gold standard treatment for anxiety disorders among typically developing youth, and innovative work by the investigative team supports its utility in children with ASD and comorbid anxiety, a protocol does not exist for early adolescents with ASD and comorbid anxiety disorders. In fact, there are no empirically supported treatment options for early adolescents with ASD and comorbid anxiety disorders; and existing pharmacological interventions may have some disadvantages (e.g., limited efficacy in this population, side effects, and potential drug x drug interactions). Accordingly, we are proposing to develop a CBT protocol for anxiety and comorbid ASD in early adolescence, as well as a credible comparison protocol (Relaxation Training; RT) for use in a future multisite clinical trial to test the efficacy of CBT in this population. In response to the Recovery Act Limited Competition, each site will hire and train at least three new study staff to conduct this study. Initial protocol development efforts will focus on adapting relevant treatment elements from an efficacious CBT program for younger children with ASD and comorbid anxiety to the characteristics and clinical needs of early adolescents. Developmentally appropriate, novel treatment components will then be added. An extant RT treatment protocol will also be modified for use with early adolescents with ASD. In response to the NIH Roadmap Initiative, attention will be paid to protocol adaptability with varying presentations. Measures of treatment integrity and competence will be developed along with the protocols. Thereafter, protocol and measure development will be refined through our experiences treating 18 young adolescents (ages 11-14 years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and expert feedback. The feasibility of implementation of both protocols will then be examined in the context of a pilot study incorporating all the features of the planned future efficacy trial comparing CBT and RT, but with a limited sample size (N = 48). At the end of the project, refined treatment manuals will be completed, integrity and competence measures will be finalized and tested for reliability and validity, and the three recruitment sites will have developed protocols promoting and assessing the consistency of treatment delivery and assessment procedures across sites, and a linked R01 grant to test the efficacy of CBT will be written. The three recruitment sites for this study are the University of California, Los Angeles (UCLA); the University of South Florida; and the University of Miami. The UCLA Neuropsychiatric (Semel) Institute's Biostatistics Core will provide data management services. Considering the rising number of youth diagnosed with ASD, and the lack of empirically supported treatment options for those young adolescents with comorbid anxiety, our proposed work toward an efficacious CBT protocol will provide a timely contribution to public health efforts. PUBLIC HEALTH RELEVANCE: Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder but has yet to be adapted to meet the unique needs of adolescents with ASD and comorbid anxiety. With more youth being diagnosed with ASD after the early childhood period, a treatment protocol such as that proposed could contribute to public health efforts to address the mental health needs of early adolescents with ASD.