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

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Behavioral: EFI-E

• Registration Number: NCT02925663
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Study Start: 2016-10-10
• Primary Completion: 2018-01-04
• Study Completion: 2018-06-28
• Status Verified: 2018-07
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EFI-E	EFI-E	10-session web-based modules to teach about executive functioning with videoconferencing with a therapist

Primary Outcome Measures

Name	Time	Method
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)	3-months

Secondary Outcome Measures

Name	Time	Method
Adherence: SimpleMed Pillboxes or MEMS TrackCaps	3-months
Quality of life: PedsQL Epilepsy Module	3-months
Seizures	3-months	A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.