1/3 CBT for Anxiety Disorders in Autism: Adapting Treatment for Adolescents

1/3 CBT 治疗自闭症焦虑症：调整青少年治疗

• 批准号: 7842833
• 负责人: Jeffrey James Wood
• 金额: $ 22.17万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7842833
• 关键词: 9 year old; Address; Adherence; Adolescent; Adverse effects; Affect; Age; Anxiety; Anxiety Disorders; Attention; Autistic Disorder; Biostatistics Core; California; Case Series; Centers for Disease Control and Prevention (U.S.); Characteristics; Child; Childhood; Clinical; Clinical Trials; Competence; Development; Diagnosis; Disadvantaged; Distress; Drug Interactions; Elements; Family; Feedback; Florida; Frequencies; Future; Gold; Grant; Impairment; Institutes; Intervention; Link; Los Angeles; Manuals; Measures; Mental Health; Mental disorders; Morbidity - disease rate; Neurobiology; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Procedures; Protocols documentation; Psychopathology; Public Health; Randomized Controlled Trials; Recovery; Relative (related person); Relaxation Therapy; Sample Size; Sampling; School-Age Population; Schools; Services; Site; Supervision; Symptoms; Testing; Training; Treatment Protocols; United States; United States National Institutes of Health; Universities; Validity and Reliability; Work; Writing; Youth; autism spectrum disorder; cognitive behavior therapy; data management; early adolescence; early childhood; efficacy testing; efficacy trial; experience; innovation; meetings; neuropsychiatry; novel; programs; protocol development; public health relevance; quality assurance; response; social; standard care; trial comparing

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.

描述（由申请人提供）：自闭症谱系障碍 (ASD) 影响美国 150 名儿童和青少年中大约 1 名，使其成为最常见的神经生物学疾病之一。共病焦虑症影响多达 80% 的 ASD 青少年，其造成的痛苦和损害远远超过仅 ASD 诊断所造成的痛苦和损害。虽然认知行为疗法 (CBT) 已被确立为典型青少年焦虑症治疗的黄金标准，并且研究团队的创新工作支持其在患有自闭症谱系障碍 (ASD) 和共病焦虑症儿童中的实用性，但尚不存在针对青少年早期的治疗方案患有 ASD 和共病焦虑症。事实上，对于患有自闭症谱系障碍和共病焦虑症的早期青少年，没有经验支持的治疗方案。现有的药物干预措施可能存在一些缺点（例如，对该人群的疗效有限、副作用以及潜在的药物间相互作用）。因此，我们建议针对青春期早期的焦虑和共病 ASD 制定 CBT 方案，以及可靠的比较方案（放松训练；RT），用于未来的多中心临床试验，以测试 CBT 在该人群中的功效。为了响应《恢复法限制竞争》，每个中心将雇用和培训至少三名新研究人员来进行这项研究。最初的方案制定工作将侧重于调整针对患有 ASD 和共病焦虑的幼儿的有效 CBT 计划中的相关治疗要素，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型治疗成分。现有的放疗治疗方案也将进行修改，以用于患有自闭症谱系障碍的早期青少年。为了响应 NIH 路线图倡议，将关注不同演示文稿的协议适应性。治疗完整性和能力的衡量标准将与方案一起制定。此后，我们将通过治疗 18 名患有 ASD 和共病焦虑症的青少年（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审查实施这两种方案的可行性，该研究纳入了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)。项目结束时，将完成完善的治疗手册，最终确定诚信和能力衡量标准并测试其可靠性和有效性，三个招募地点将制定协议，促进和评估治疗提供的一致性以及跨地点的评估程序，并将编写链接的 R01 拨款来测试 CBT 的功效。本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（塞梅尔）研究所的生物统计学核心将提供数据管理服务。考虑到诊断患有自闭症谱系障碍的青少年人数不断增加，以及患有共病焦虑的青少年缺乏经验支持的治疗方案，我们提出的有效 CBT 方案的工作将为公共卫生工作做出及时的贡献。 公共卫生相关性：共病焦虑症影响多达 80% 的自闭症谱系障碍青少年，除了自闭症谱系诊断之外，还会造成严重的痛苦和损害。认知行为疗法 (CBT) 是患有焦虑症的典型发育青少年的黄金标准治疗方法，但尚未适应患有 ASD 和共病焦虑症青少年的独特需求。随着越来越多的青少年在幼儿期后被诊断出患有自闭症谱系障碍，所提出的治疗方案可能有助于公共卫生工作，以满足患有自闭症谱系障碍的青少年的心理健康需求。