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OpenTrials
Completed

NCT Number: NCT02925663

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

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).

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EFI-E

Behavioral

This is 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.

Primary outcomes

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

    Time frame: 3-months

Secondary outcomes

  1. Adherence: SimpleMed Pillboxes or MEMS TrackCaps

    Time frame: 3-months

  2. Quality of life: PedsQL Epilepsy Module

    Time frame: 3-months

  3. Seizures

    Time frame: 3-months

    A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.

Other outcomes

  1. Child behavioral and emotional functioning: Behavior Assessment Schedule for Children-2

    Time frame: 3-months

  2. Treatment Feasibility

    Time frame: 3-months

    Treatment Feasibility and Acceptability Questionnaire

  3. Executive functioning-BRIEF

    Time frame: 5-months

  4. Executive functioning-BRIEF

    Time frame: 8-months

  5. Adherence-SImple Med Pillbox or MEMS TrackCaps

    Time frame: 8-months

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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