Feasibility, Preliminary Effectiveness, and Sustainability of a Cognitive-Behavioral Therapy Program Tailored for Youth with Autism and Anxiety Treated in Real-World Community-Based Clinics

项目总结/摘要 自闭症谱系障碍（ASD）是一种常见的神经发育障碍，影响54名美国儿童中的1名。 同时发生的焦虑影响了40%至50%的ASD儿童，造成严重的痛苦和损害。 对于ASD儿童的父母来说，焦虑的治疗是一个高度优先的问题，而认知行为疗法（CBT） 针对ASD进行的改良治疗已经证明了相对于标准护理CBT和常规护理的疗效。但现有 已经为学术医疗环境制定了协议，利益相关者的投入有限， 相应地减少了社区诊所在现实世界中的应用潜力。因此，我们建议 一项研究，其中来自农村和城市社区的利益相关者充分参与制定CBT 干预和相关的临床医生培训协议-社区为基础的焦虑程序量身定制的自闭症 （CAPTA）-能够在社区精神卫生环境中随时使用。我们将初步 评估治疗反应和机制。在目标1方面，我们会与下列儿童的家长进行需要评估： 青少年与ASD和共同发生的焦虑，社区精神卫生临床医生，和社区精神卫生 诊所领导人;我们还将咨询CBT专家咨询委员会，以解决青少年共同出现的焦虑问题 ASD患者和有生活经验的个体（即，父母和自我辩护者）。这一反馈来自 利益攸关方和专家将直接为《反贫困和技术援助行动计划》的调整提供信息。我们将进行一个小型的公开审判 （N=10），目的是获得真实世界的经验和完善的治疗和测量协议。 目标2涉及一项初步随机对照试验，在该试验中，在两个不同的研究中， 社区心理健康中心（N=60）。我们会研究该计划的初步成效， 焦虑症状的严重程度和损害，我们也将探讨理论导向的治疗机制。 目标3侧重于实施成果（忠实性、可行性、可接受性）和影响实施的背景因素 CAPTA的实施和维持。拟议的项目与 机构间自闭症协调委员会将扩大和实施循证干预措施， 社区设置，扩大服务劳动力，并加快从研究到实践的管道。 具体来说，这项试点研究将建立运输的可行性和可接受性CBT的青少年与ASD 和共同发生的焦虑到社区心理健康诊所，然后再发展到一个更大的混合效果- 在R 01中进行实施试验。

PROJECT SUMMARY/ABSTRACT Autism spectrum disorder (ASD) is a common neurodevelopmental disorder affecting 1 in 54 U.S. children. Co-occurring anxiety affects 40 to 50% of children with ASD, causing substantial distress and impairment. Treatment of anxiety is a high priority for parents of children with ASD, and cognitive-behavioral therapy (CBT) modified for ASD has demonstrated efficacy relative to standard care CBT and usual care. However, existing protocols have been established for academic medical settings with limited stakeholder input and correspondingly diminished potential for real-world uptake in community-based clinics. Accordingly, we propose a study in which stakeholders from both rural and urban communities are fully engaged to develop a CBT intervention and associated clinician training protocol - Community-based Anxiety Program Tailored for Autism (CAPTA) - that is able to be readily employed in community mental health settings. We will then preliminarily evaluate treatment response and mechanisms. In Aim 1, we will conduct a needs assessment with parents of youth with ASD and co-occurring anxiety, community mental health clinicians, and community mental health clinic leaders; we will also consult with an Advisory Board of experts in CBT for co-occurring anxiety in youth with ASD and individuals with lived experience (i.e., parents and self-advocates). This feedback from stakeholders and experts will directly inform adaptations to CAPTA. We will then conduct a small open trial (N=10) with the goal of obtaining real-world experience and refining the treatment and measurement protocols. Aim 2 involves a pilot randomized controlled trial in which CAPTA is compared to usual care in two different community-based mental health centers (N=60). We will examine CAPTA’s preliminary effectiveness to improve anxiety symptom severity and impairment, and we will also explore theoretically oriented treatment mechanisms. Aim 3 focuses on implementation outcomes (fidelity, feasibility, acceptability) and contextual factors influencing CAPTA implementation and sustainment. The proposed project is well-aligned with recommendations from the Interagency Autism Coordinating Committee to scale up and implement evidence-based interventions in community settings, expand the services workforce, and accelerate the pipeline from research to practice. Specifically, this pilot study will establish the feasibility and acceptability of transporting CBT for youth with ASD and co-occurring anxiety to community mental health clinics before progressing to a larger hybrid effectiveness- implementation trial in an R01.