Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

项目总结 当前项目的目标是详述、重建和推进到关键的试验就绪蝉 《改善自闭症青少年认知的护理》--临床医生协助的闭环式研究 技术，为患有自闭症谱系障碍(ASD)的青少年提供移动应用程序。通过十个移动电话 评估蝉将捕捉有关感觉处理异常和相关认知缺陷的数据。 这些数据将填充机器学习算法，该算法将定制10个基于神经可塑性的 针对感觉加工异常的社会认知训练(NB-SCT)练习。这是个性化的 评估和治疗方法被认为是诱导关于社会情绪的适应性长期学习的方法 事件，从而最大限度地提高以心理证据为基础的靶向治疗的影响和普遍性 社交技能和关系策略，包括同伴 (教育和充实计划 人际关系技巧)。特别是，我们假设蝉诱导的加工和认知的增强将 促进同伴技能在患有自闭症青少年的环境中的应用，从而提高他们的实际生活质量 世界在运转。 在这个项目中，我们将建立在焦虑和精神病的两个研究成果的基础上，杠杆 在患有自闭症谱系障碍(ASD)的青少年中收集初步数据，并积累初步证据 蝉的作用是：1)单独治疗；2)同伴入门；3)同伴的增强剂。 在具体目标1中，我们将最终确定开发，确保评估数据正确填充已关闭的- 循环算法，正确引导个性化NB-SCT的交付。接下来，我们将涉及三名青少年 与ASD和两名同行临床医生在三个焦点小组将被组织起来，以完善蝉。一次 关于应用程序设计的决定已经做出，这三名青少年将参与为期两周的试运行以验证 蝉正在检测和改善感觉处理异常和认知缺陷。在…的末尾 在此测试运行中，每个利益相关者将被要求对享受性、易用性、产品质量和感知进行评级 有用处。最后，我们将把试运行中的这些数据提交给我们的顾问，以确认蝉是 适合在可行性试验中进行评估。在具体目标2中，我们将进行三臂 对48名患有自闭症的青少年进行的随机交叉试验，以记录蝉和 评估其作为单独治疗、作为同行入门读物或作为同行治疗增强剂的潜力。 在这个项目完成后，我们将有足够的可用性数据来支持第二阶段的疗效试验 旨在确立医疗索赔。在第二阶段完成后，我们将能够完成FDA 这是一种有效的监管途径，并有机会改善患有这种疾病的人的生活。

PROJECT SUMMARY The goal of the current project is to elaborate upon, reconstruct and advance to pivotal trial readiness CICADAS (Care Improving Cognition for ADolescents on the Autism Spectrum)—a clinician-assisted, closed-loop technology, mobile application for adolescents with Autism Spectrum Disorder (ASD). Via ten mobile assessments CICADAS will capture data on sensory processing abnormalities and associated cognitive deficits. These data will populate a machine learning algorithm that will tailor the delivery of ten neuroplasticity-based social cognitive training (NB-SCT) exercises targeting sensory processing abnormalities. This individualized assessment and treatment approach is posited to induce adaptive long-term learning about social-emotional events, thus maximizing the impact and generalizability of psychological Evidence Based Treatments targeting social skills and relational strategies, including PEERS (Program for the Education and Enrichment of Relationship Skills). In particular, we posit that CICADAS-induced enhancement of processing and cognition will facilitate the application of PEERS skills in the environment of adolescents with ASD, thus improving their real- world functioning. In this project, we will build upon promising results obtained from two studies in anxiety and psychosis, leverage pilot data collected in adolescents with Autism Spectrum Disorder (ASD), and accumulate preliminary evidence for CICADAS to function as 1) a stand-alone treatment; 2) a primer for PEERS; 3) an enhancer for PEERS. In Specific Aim 1, we will finalize development, ensuring that assessment data correctly populate the closed- loop algorithm and correctly guide the delivery of individualized NB-SCT. Next, we will involve three adolescents with ASD and two PEERS clinicians in three focus groups that will be organized to refine CICADAS. Once decisions regarding app design are made, the three adolescents will be involved in a 2-week trial run to verify that CICADAS is detecting and improving sensory processing abnormalities and cognitive deficits. At the end of this test run, each stakeholder will be asked to rate enjoyment, ease of use, product quality, and perceived usefulness. Finally, we will submit these data from the trial run to our consultant to confirm that CICADAS is suitable for evaluation in the feasibility trial. In Specific Aim 2, we will conduct a three-arm randomized crossover trial with 48 adolescents with ASD to document the acceptability of CICADAS and evaluate its potential as a stand-alone treatment, as a primer for PEERS, or as a treatment enhancer of PEERS. At the completion of this project we will have usability data sufficient to support an efficacy trial in Phase II designed to establish medical claims. At the completion of Phase II, we will be able to complete the FDA regulatory pathway and have the opportunity to improve the lives of people suffering from this condition.