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

项目摘要/摘要 自闭症谱系障碍(ASD)是一种常见的神经发育障碍，每54名美国儿童中就有一名受到影响。 40%到50%的自闭症儿童会受到共生焦虑的影响，导致严重的痛苦和损害。 对于患有自闭症儿童的父母来说，焦虑的治疗是高度优先的，认知行为疗法(CBT) 与标准护理、CBT和常规护理相比，针对ASD的改良已显示出疗效。然而，现有的 已经为学术医疗环境建立了协议，利益相关者的输入有限，并且 相应地，以社区为基础的诊所在现实世界中采用的潜力也降低了。因此，我们建议 一项研究，来自农村和城市社区的利益相关者充分参与制定CBT 干预和相关临床医生培训方案--为自闭症量身定做的基于社区的焦虑方案 (CAPTA)-能够在社区心理健康环境中随时就业的人。然后我们将初步地 评估治疗反应和机制。在目标1中，我们将与家长一起进行需求评估 患有自闭症和焦虑症的青少年、社区心理健康临床医生和社区心理健康 临床领导；我们还将咨询CBT专家咨询委员会，以解决青年中的共生焦虑问题 与自闭症和有生活经验的个人(即父母和自我倡导者)合作。这一反馈来自 利益攸关方和专家将直接为适应Capta提供信息。然后我们将进行一次小型的公开试验 (n=10)，目的是获得真实世界的经验并完善治疗和测量方案。 AIM 2涉及一项先导随机对照试验，在该试验中，将CAPTA与两种不同的常规护理进行比较 社区精神卫生中心(N=60)。我们将审查Capta的初步有效性，以改进 焦虑症状的严重程度和损害，我们还将探索理论导向的治疗机制。 目标3侧重于执行结果(保真度、可行性、可接受性)和影响执行结果的背景因素 履约协助方案的实施和维持。拟议的项目与 机构间自闭症协调委员会扩大和实施循证干预措施 社区环境，扩大服务队伍，加快从研究到实践的管道。 具体地说，这项初步研究将确定为患有自闭症的青少年运送CBT的可行性和可接受性 在取得更大的混合疗效之前，将焦虑和共生焦虑转移到社区心理健康诊所- 在R01上进行实施试验。

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.