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

改善自闭症谱系青少年认知能力的护理 (CICADAS)

• 批准号: 10266160
• 负责人: Hyun Kyu Lee
• 金额: $ 26.03万
• 依托单位: POSIT SCIENCE CORPORATION
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266160
• 关键词: Adolescent; Age; Algorithms; Anxiety; Brain; Caregivers; Caring; Clinic; Clinical; Cognition; Cognitive deficits; Collaborations; Cross-Over Trials; Data; Development; Education; Emotional; Enhancers; Ensure; Environment; Evaluation; Event; Evidence based treatment; Exercise; Focus Groups; Goals; Interpersonal Relations; Intervention; Learning; Link; Medical; Minnesota; Neurodevelopmental Disorder; Neuronal Plasticity; Outcome; Parents; Participant; Pattern; Perception; Performance; Phase; Program Sustainability; Psychoses; Quality of life; Randomized; Regulatory Pathway; Running; Sensory; Social Behavior; Social Interaction; Social skills development; Surveys; System; Technology; Teenagers; Testing; Time; Universities; Validation; Waiting Lists; Youth; adherence rate; adolescent with autism spectrum disorder; anxious; arm; autism spectrum disorder; base; cognitive training; design; digital; efficacy trial; evidence base; experience; feasibility trial; flexibility; improved; machine learning algorithm; mobile application; phase 2 designs; programs; psychologic; reduce symptoms; relating to nervous system; response; skills; smartphone based assessment; social; social cognition; social skills; treatment response; trial readiness; usability; week trial

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.

项目摘要 当前项目的目标是详细说明、重建和推进CICADAS，使其为关键的试验做好准备。 (Care改善自闭症谱系青少年的认知）-一个临床医生辅助的闭环 技术，移动的应用程序的青少年自闭症谱系障碍（ASD）。通过十个移动的 评估CICADAS将捕获关于感觉处理异常和相关认知缺陷的数据。 这些数据将填充一个机器学习算法，该算法将定制十个基于神经可塑性的 社会认知训练（NB-SCT）针对感觉处理异常的练习。这种个性化 评估和治疗的方法是假定诱导适应性长期学习的社会情绪 事件，从而最大限度地发挥心理循证治疗目标的影响和普遍性 社会技能和关系战略，包括PEERS （教育和丰富妇女知识方案） 关系技巧）。特别是，我们认为CICADAS诱导的加工和认知增强将 促进在ASD青少年环境中应用PEERS技能，从而提高他们的真实的 世界运转。 在本项目中，我们将在焦虑和精神病两项研究中取得的有希望的结果的基础上，利用 在患有自闭症谱系障碍（ASD）的青少年中收集的试点数据，并积累初步证据 对于CICADAS来说，其功能是：1）独立治疗; 2）PEERS的引物; 3）PEERS的增强剂。 在具体目标1中，我们将完成开发，确保评估数据正确地填充封闭的 循环算法，正确引导个体化NB-SCT的输送。接下来，我们将涉及三名青少年 与ASD和两名PEERS临床医生组成三个焦点小组，将组织完善CICADAS。一旦 关于应用程序设计的决定作出后，三名青少年将参与为期2周的试运行，以验证 CICADAS正在检测和改善感觉处理异常和认知缺陷。结束时 在这次测试中，每个利益相关者都将被要求对享受、易用性、产品质量和感知进行评级。 有用性最后，我们将把这些试运行数据提交给我们的顾问，以确认CICADAS是 适合在可行性试验中进行评价。在具体目标2中，我们将进行三臂 在48名ASD青少年中进行的随机交叉试验，以记录CICADAS的可接受性， 评估其作为独立治疗、作为PEERS引物或作为PEERS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。 旨在建立医疗索赔。在第二阶段完成后，我们将能够完成FDA 监管途径，并有机会改善患有这种疾病的人的生活。