Web-based Intervention to Improve Executive Functioning in Teens with Epilepsy

 描述(由申请人提供)：癫痫是一种常见的儿童疾病，在美国大约有326,000名年轻人受到影响。患有癫痫的青少年面临着社会和学术成果差、神经行为并存(即症状内化和外化)以及治疗依从性差的重大风险。研究表明，这些糟糕结果的一个潜在原因是执行功能(EF)缺陷，即目标导向的复杂活动所需的技能，包括解决问题、启动、监控、组织、计划、自我调节和工作记忆。1/3的青年癫痫患者存在EF缺陷，是健康青年患病率的3倍。改善EF的循证干预可以在预防不良后果(例如，心理并存、不遵守治疗方案)和促进青少年癫痫患者的最佳功能方面发挥关键作用；然而，对于这一脆弱群体来说，这一点都不存在。本研究的目的是开发一种个性化的干预措施，通过迭代的、以患者为中心的过程来改善青少年癫痫患者的EF(执行功能干预-癫痫；EFI-E)，其中包括：1)确定 根据焦点小组反馈，癫痫青少年及其家庭的独特需求(阶段1)，2)修订的干预方案的可用性测试，以获得关于适用性、内容和个体化方法的反馈(阶段2)，以及3)开放标签试验，以确定EFI-E治疗青少年癫痫的可行性、可及性、可接受性和初步效果(阶段3)。我们计划为所有3个阶段招募50名参与者(阶段1；n=6-10；阶段2；n=6-10；阶段3；n=30)。参与者将在执行功能行为评定表(Brief(R))上至少有一个临床升高的EF子量表或至少两个风险子量表得分(&gt；1个标准差高于平均值)，才有资格参加EFI-E。EFI-E将由8-10个基于网络的模块组成，涉及基本的EF技能，包括：解决问题的技能、自我调节、工作记忆、监控和计划/组织。干预的前三个模块将得到修复；然而，其余模块将根据青少年最突出的EF缺陷和偏好进行定制。每个在线模块将伴随着与治疗师的视频会议，以审查围绕青少年确定的目标的技能和问题解决方案。基线和治疗后问卷将由青少年和主要照顾者完成，并将在整个开放试验期间获得电子监测的依从性。该项目解决了循证干预的迫切需要，以改善EF，减少神经行为并存，并改善高危癫痫人群中AED的不依从性。这种干预有可能最终改善一大批癫痫青少年的学习成绩、社会功能、睡眠、耻辱和与健康相关的生活质量。这项研究还为检验EFI-E在改善青少年结局方面的有效性的更大规模的多点临床试验奠定了基础。

 DESCRIPTION (provided by applicant): Epilepsy is a common childhood condition affecting approximately 326,000 youth in the United States. Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and poor treatment adherence. Studies have shown that one potential reason for these poor outcomes are deficits in executive functioning (EF), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation and working memory. EF deficits have been documented in 1/3 of youth with epilepsy, which is 3 times the prevalence in healthy youth. Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and promoting optimal functioning in adolescents with epilepsy; however none exists for this vulnerable population. The aim of the current study is to develop an individually-tailored intervention to improve EF in adolescents with epilepsy (Executive Functioning Intervention-Epilepsy; EFI-E) through an iterative, patient-centered process that includes: 1) identification of the unique needs of adolescents with epilepsy and their families based on focus group feedback (Phase 1), 2) usability testing of a revised intervention protocol to elicit feedback on the applicability, content, and individualized approach (Phase 2), and finally 3) an open-label trial t establish the feasibility, accessibility, acceptability, and preliminary effect of the EFI-E for adolescents with epilepsy (Phase 3). We plan to recruit 50 participants for all 3 phases (Phase 1; n=6-10; Phase 2; n=6-10; Phase 3; n=30). Participants will have at least one clinically-elevated EF subscale or at least two at-risk subscale scores on (> 1 standard deviation above the mean) on the Behavior Rating Inventory of Executive Function (BRIEF(r))) to qualify for the EFI-E. EFI-E will consist of 8-10 web-based modules addressing foundational EF skills including: problem-solving skills, self-regulation, working memory, monitoring, and planning/organizing. The first three modules of the intervention will be fixed; however, the remaining modules will be tailored based on the adolescent's most prominent EF deficit and preference. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around an adolescent-identified goal. Baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial. This project addresses the critical need for evidence-based interventions to improve EF, reduce neurobehavioral comorbidities, and improve AED non-adherence in a high risk epilepsy population. This intervention has the potential to ultimately improve academic performance, social functioning, sleep, stigma, and health-related quality of life in a large subgroup of adolescents with epilepsy. This study also lays the foundation for larger multi-site clinical trial examining the efficacy of EFI-E in improving adolescent outcomes.