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）影响美国150名儿童和青少年中的约1名，使其成为最常见的神经生物学疾病之一。共病焦虑障碍影响多达80%的ASD青少年，造成严重的痛苦和损害，超过单独诊断ASD所造成的痛苦和损害。虽然认知行为疗法（CBT）已被确立为典型发育中的青少年焦虑症的金标准治疗方法，并且调查小组的创新工作支持其在ASD和共病焦虑症儿童中的效用，但对于ASD和共病焦虑症的早期青少年并不存在协议。事实上，对于患有ASD和共病焦虑症的早期青少年没有经验支持的治疗选择;并且现有的药物干预可能具有一些缺点（例如，在该人群中的有限功效、副作用和潜在的药物X药物相互作用）。因此，我们建议开发一种针对青少年早期焦虑和共病ASD的CBT方案，以及一种可信的比较方案（放松训练; RT），用于未来的多中心临床试验，以测试CBT在该人群中的疗效。为响应《恢复法案》的限制竞争，每家研究中心将雇用并培训至少三名新的研究工作人员来开展本研究。最初的方案开发工作将侧重于调整相关的治疗元素，从一个有效的CBT计划，为年幼的儿童ASD和共病焦虑的特点和早期青少年的临床需求。然后将添加适合发展的新型治疗成分。一个现存的RT治疗方案也将被修改用于早期青少年ASD。为了响应NIH路线图倡议，将注意不同演示文稿的协议适应性。将沿着方案制定治疗完整性和能力的衡量标准。此后，将通过我们治疗18名患有ASD和共病焦虑障碍的青少年（年龄11-14岁）的经验以及临床医生，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检查这两种方案实施的可行性，该研究将纳入计划的未来疗效试验的所有特征，比较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，完整性和能力措施将最终确定并测试可靠性和有效性，三个招募地点将制定促进和评估治疗交付和评估程序一致性的协议，并将编写相关的R 01赠款以测试CBT的有效性。本研究的三个招募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（塞梅尔）研究所的生物统计核心将提供数据管理服务。考虑到越来越多的青少年被诊断患有ASD，以及缺乏经验支持的治疗方案，为那些年轻的青少年与共病焦虑，我们提出的工作对一个有效的CBT协议将提供一个及时的贡献公共卫生工作。 公共卫生相关性：共病焦虑障碍影响了多达80%的自闭症谱系障碍青少年，造成了严重的痛苦和损害，而不仅仅是自闭症谱系障碍的诊断。认知行为疗法（CBT）是典型的青少年焦虑症患者的金标准治疗，但尚未适应ASD和共病焦虑青少年的独特需求。随着越来越多的青少年在幼儿期后被诊断出患有ASD，所提出的治疗方案可能有助于公共卫生工作，以解决患有ASD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.