Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
February 4, 2020 updated by: Children's Hospital Medical Center, Cincinnati
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EFI-E
10-session web-based modules to teach about executive functioning with videoconferencing with a therapist
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: 3-months
|
3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence: SimpleMed Pillboxes or MEMS TrackCaps
Time Frame: 3-months
|
3-months
|
|
|
Quality of life: PedsQL Epilepsy Module
Time Frame: 3-months
|
3-months
|
|
|
Seizures
Time Frame: 3-months
|
A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.
|
3-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child behavioral and emotional functioning: Behavior Assessment Schedule for Children-2
Time Frame: 3-months
|
3-months
|
|
|
Treatment Feasibility
Time Frame: 3-months
|
Treatment Feasibility and Acceptability Questionnaire
|
3-months
|
|
Executive functioning-BRIEF
Time Frame: 5-months
|
5-months
|
|
|
Executive functioning-BRIEF
Time Frame: 8-months
|
8-months
|
|
|
Adherence-SImple Med Pillbox or MEMS TrackCaps
Time Frame: 8-months
|
8-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2016
Primary Completion (Actual)
January 4, 2018
Study Completion (Actual)
June 28, 2018
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 4, 2016
First Posted (Estimate)
October 6, 2016
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21HD083335 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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