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Clinical Trials/NCT02925663
NCT02925663
Completed
Phase 2

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

Children's Hospital Medical Center, Cincinnati0 sites32 target enrollmentOctober 10, 2016
ConditionsEpilepsy

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
32
Primary Endpoint
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2016
End Date
June 28, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 3-months

Secondary Outcomes

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

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