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

• 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
• 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

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.

项目摘要 该提案的总体目标是进行儿科综合性的第一次机械临床试验， 抽搐行为干预（CBIT），以识别生物行为预测因子以及反应和 CBIT交付的最有效方面。慢性抽搐影响美国1-3%的青少年，是一种致残性疾病。 与多种儿童期发作的精神障碍相关的神经精神症状。CBIT是目前 一线，金标准治疗抽搐，并侧重于技能，以加强自愿抽搐抑制， 减少抽搐的诱因。然而，大约50%的年轻人没有从CBIT中受益。本研究旨在利用 多模态测量以识别响应预测因子（CBIT对谁有效？），治疗 激活变化的过程（CBIT交付的有效方面是什么？），和反应的相关性 (what在抽搐改善的患者中发生变化？）。研究假设，基于文献和我们的 初步数据，预测CBIT依赖，从事，并加强内部和之间的连接 支持自上而下控制运动功能的功能性大脑网络。10-17岁青年， 慢性抽搐（N = 100）将完成8个门诊疗程，每周一次的CBIT治疗， 3-一个月的跟踪评估。多模式评估将包括：1）功能性神经测量 在休息和抽搐期间使用fMRI和EEG的大脑大规模功能网络之间的连接 表达和抑制，2）抽搐的直接观察行为测量，和3）心理社会 测量，包括临床症状评估和以患者为中心的结局测量， 初步数据和我们的患者咨询委员会。CBIT过程将通过一个新的基于视频的评估 CBIT会话的行为编码。该项目有可能直接使患者受益， 从长远来看。结果将通过告知个体化，对临床实践产生下游影响 治疗计划和努力简化和提高CBIT质量。结果也将有一个上游 通过确定新的神经靶点进行干预和治疗策略对治疗发展的影响 通过改进或改进程序改善CBIT结果。