Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

儿科抽动综合行为干预反应的多模式分析

基本信息

批准号：
10743782
负责人：
Christine A Conelea
金额：
$ 79.23万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-12 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10743782
关键词：
Affect Age Behavior Behavior Therapy Behavioral Brain Child Childhood Chronic Clinical Clinical Trials Clinical assessments Code Data Decision Making Electroencephalography Elements Functional Magnetic Resonance Imaging Future Gilles de la Tourette syndrome Goals Impairment Improve Access Impulsivity Intervention Knowledge Link Literature Logistic Regressions Measurement Measures Mental disorders Methods Modeling Motor Movement Multi-Institutional Clinical Trial Obsessive-Compulsive Disorder Outcome Outcome Measure Outpatients Patient-Focused Outcomes Patients Procedures Process Provider Research Rest Sampling Seminal Severities Signal Transduction Symptoms Therapeutic Tic disorder Work Youth associated symptom behavior measurement behavior observation bench-to-bedside translation biobehavior clinical practice design efficacy trial experience follow up assessment functional magnetic resonance imaging/electroencephalography improved indexing individualized medicine magnetic resonance imaging/electroencephalography member motor control multidisciplinary multimodality neural neuropsychiatric disorder neuropsychiatric symptom neuroregulation novel patient engagement predicting response predictive marker predictive modeling primary care setting profiles in patients prognostic indicator psychosocial repetitive behavior research and development response skills standard care support network therapeutic target therapy development tic suppression treatment adherence treatment planning vocalization

项目摘要

PROJECT SUMMARY The overall objective of this proposal is to conduct the first mechanistic clinical trial of pediatric Comprehensive Behavioral Intervention for Tics (CBIT) to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT delivery. Chronic tics affect 1-3% of youth in the US and are a disabling neuropsychiatric symptom associated with multiple childhood-onset mental disorders. CBIT is the current first-line, gold-standard treatment for tics and focuses on skills to enhance voluntary tic suppression and reduce tic triggers. However, about 50% of youth do not benefit from CBIT. The current study aims to use multimodal measurements to identify predictors of response (for whom does CBIT work?), the therapeutic processes that activate change (what are the potent aspects of CBIT delivery?), and correlates of response (what changes occur in patients whose tics improve?). Study hypotheses, based on the literature and our preliminary data, predict that CBIT relies upon, engages, and strengthens connectivity within and between functional brain networks that support top-down control over motor functions. Youth ages 10-17 years with chronic tics (N = 100) will complete a course of 8 outpatient, weekly sessions of CBIT and pre-, post-, and 3-month follow up assessments. Multimodal assessments will include: 1) neural measures of functional connectivity among the brain's large-scale functional networks using fMRI and EEG during rest and tic expression and suppression, 2) direct-observation behavioral measurement of tics, and 3) psychosocial measures, including assessments of clinical symptoms and patient-centered outcome measures informed by preliminary data and our Patient Advisory Board. CBIT process will be assessed via a novel video-based behavioral coding of CBIT sessions. This project has the potential to directly benefit patients both immediately and in the long-term. Results will have a downstream impact on clinical practice by informing individualized treatment planning and efforts to streamline and improve CBIT quality. Results will also have an upstream impact on treatment development by identifying novel neural targets for intervention and strategies for improving CBIT outcomes via refinement or adjunctive procedures.

项目概要该提案的总体目标是进行第一个儿科综合性临床试验抽动症行为干预 (CBIT)，用于识别生物行为预测因素以及反应和症状的相关性 CBIT 交付最有效的方面。慢性抽动症影响美国 1-3% 的青少年，是一种致残性疾病与多种儿童期发病的精神障碍相关的神经精神症状。 CBIT 是当前抽动症的一线黄金标准治疗，重点是增强自愿抽动抑制和治疗的技能减少抽动触发因素。然而，大约 50% 的青少年没有从 CBIT 中受益。目前的研究旨在利用多模式测量以确定反应的预测因素（CBIT 对谁有效？）激活变革的流程（CBIT 交付的有效方面是什么？）以及响应的相关性（抽动改善的患者会发生什么变化？）。基于文献和我们的研究假设初步数据预测 CBIT 依赖、参与并加强内部和之间的连通性支持对运动功能进行自上而下控制的功能性大脑网络。 10-17岁的青少年慢性抽动症 (N = 100) 将完成 8 次门诊、每周 CBIT 疗程以及治疗前、治疗后和治疗后的疗程。 3个月的跟踪评估。多模式评估将包括：1）功能的神经测量使用功能磁共振成像和脑电图在休息和抽动期间大脑大规模功能网络之间的连接表达和抑制，2) 抽动的直接观察行为测量，以及 3) 社会心理措施，包括临床症状评估和以患者为中心的结果措施初步数据和我们的患者咨询委员会。 CBIT 流程将通过新颖的基于视频的方式进行评估 CBIT 会话的行为编码。该项目有可能立即使患者直接受益从长远来看。结果将通过告知个体化治疗对临床实践产生下游影响治疗计划以及简化和提高 CBIT 质量的努力。结果也会有上游通过确定新的神经干预目标和策略来影响治疗发展通过细化或辅助程序改善 CBIT 结果。