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临床试验/NCT02925663
NCT02925663已完成2 期

Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)

Children's Hospital Medical Center, Cincinnati0 个研究点目标入组 32 人开始时间: 2016年10月10日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
32
主要终点
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)

研究概览

简要总结

The purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E).

详细描述

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 establish the feasibility, accessibility, acceptability, and preliminary effects of an individually-tailored intervention to improve EF in adolescents with epilepsy (Executive Functioning Intervention-Epilepsy; EFI-E). Thirty participants will be recruited who have at least one clinically-elevated EF subscale or at least two at-risk subscale scores (> 1 standard deviation above the mean) on the parent Behavior Rating Inventory of Executive Function (BRIEF®)) to qualify for the EFI-E. EFI-E will consist of 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals. Baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial. Participants will be in the trial for 9 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 13-17 years
  • •Diagnosis of epilepsy
  • •Have at least two subclinical (>1 SD; T score between 60-65) or one clinically-elevated BRIEF subscale (T score > 65)
  • •Primary caregiver consent and adolescent assent to participate in study

排除标准

  • •Diagnosis of non-epilepsy medical disorders requiring daily medications with the exception of asthma and/or allergies
  • •Diagnosis of significant developmental disorders (e.g. Autism)
  • •Inability to read and speak English due to the questionnaires and intervention only been developed in English
  • •Family lives greater than 100 miles away from CCHMC
  • •If patient is planning to wean from their antiepileptic medication within the next 6 months

研究组 & 干预措施

EFI-E

Experimental

10-session web-based modules to teach about executive functioning with videoconferencing with a therapist

干预措施: EFI-E (Behavioral)

结局指标

主要结局

Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)

时间窗: 3-months

次要结局

  • Adherence: SimpleMed Pillboxes or MEMS TrackCaps(3-months)
  • Quality of life: PedsQL Epilepsy Module(3-months)
  • Seizures(3-months)

研究者

申办方类型
Other
责任方
Sponsor

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