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

基于网络的干预措施可改善癫痫青少年的执行功能

• 批准号: 9034764
• 负责人: AVANI C MODI
• 金额: $ 23.4万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-02-12 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9034764
• 关键词: 17 year old; Address; Adherence; Adolescent; Affect; Aftercare; Antiepileptic Agents; Attention deficit hyperactivity disorder; Behavior; Behavior Therapy; Caring; Child; Childhood; Comorbidity; Complex; Data; Epilepsy; Equipment and supply inventories; Evidence based intervention; Executive Dysfunction; Exhibits; Family; Feedback; Focus Groups; Foundations; Future; Goals; Group Interviews; Health; Impairment; Individual; Informal Social Control; Intervention; Intervention Trial; Link; Measures; Medical; Memory; Memory impairment; Methodology; Modeling; Monitor; Multi-Institutional Clinical Trial; Neurobehavioral Manifestations; Neurodevelopmental Disorder; Neurologic; Online Systems; Outcome; Participant; Performance; Pharmaceutical Preparations; Phase; Play; Population; Prevalence; Problem Solving; Process; Protocols documentation; Qualifying; Quality of life; Questionnaires; Recruitment Activity; Risk; Role; Seizures; Short-Term Memory; Sleep; Social Functioning; Socioeconomic Status; Subgroup; Symptoms; Technology; Teenagers; Testing; Thinking; Time; Traumatic Brain Injury; Treatment Protocols; United States; Videoconferences; Videoconferencing; Vulnerable Populations; Work; Youth; acronyms; adverse outcome; base; depressive symptoms; executive function; health related quality of life; high risk; improved; inattention; innovation; neglect; neurobehavioral; open label; patient oriented; personalized approach; preference; prevent; primary caregiver; problem solving therapy; psychologic; skills; social; social stigma; therapy design; treatment adherence; usability

 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.

 描述（由申请人提供）：癫痫是一种常见的儿童疾病，影响了美国约326，000名青少年。患有癫痫的青少年有很大的风险，社会和学术成果差，神经行为共病（即，内化和外化症状）和治疗依从性差。研究表明，这些不良结果的一个潜在原因是执行功能（EF）的缺陷，执行功能被定义为目标导向和复杂活动所需的技能，包括解决问题，启动，监测，组织，计划，自我调节和工作记忆。1/3的癫痫青年有EF缺陷，是健康青年患病率的3倍。改善EF的循证干预措施在预防不良结局方面发挥关键作用（例如，心理共病、不依从治疗方案）和促进青少年癫痫患者的最佳功能;然而，对这一弱势群体没有任何措施。本研究的目的是通过一个迭代的、以患者为中心的过程，开发一种个性化的干预措施，以改善青少年癫痫患者的EF（执行功能干预-癫痫; EFI-E），该过程包括：1）识别 基于焦点小组反馈的癫痫青少年及其家庭的独特需求（第1阶段），2）修订干预方案的可用性测试，以获得对适用性、内容和个性化方法的反馈（第2阶段），最后3）开放标签试验，以确定EFI-E对癫痫青少年的可行性、可及性、可接受性和初步效果（第3阶段）。我们计划在所有3个阶段招募50名参与者（第1阶段; n=6-10;第2阶段; n=6-10;第3阶段; n=30）。参与者将在执行功能行为评定量表（BRIEF（r））上具有至少一个临床升高的EF子量表或至少两个风险子量表评分（高于平均值> 1个标准差），以符合EFI-E。EFI-E将包括8-10个基于网络的模块，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，监控和规划/组织。干预的前三个模块将是固定的;然而，其余模块将根据青少年最突出的EF缺陷和偏好进行调整。每个在线模块都将伴随着与治疗师的视频会议，以审查技能和解决问题的能力。青少年和主要照顾者将完成基线和治疗后问卷，并在整个开放试验期间获得电子监测的依从性。该项目解决了对循证干预的迫切需求，以改善EF，减少神经行为合并症，并改善高危癫痫人群的AED非依从性。这种干预有可能最终改善一个大型癫痫青少年亚组的学习成绩，社会功能，睡眠，耻辱和健康相关的生活质量。这项研究也为更大规模的多中心临床试验奠定了基础，该试验旨在检查EFI-E在改善青少年结局方面的疗效。