Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EFI-E
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring executive functioning
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EFI-E
Arm Description
10-session web-based modules to teach about executive functioning with videoconferencing with a therapist
Outcomes
Primary Outcome Measures
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
Secondary Outcome Measures
Adherence: SimpleMed Pillboxes or MEMS TrackCaps
Quality of life: PedsQL Epilepsy Module
Seizures
A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.
Full Information
NCT ID
NCT02925663
First Posted
October 3, 2016
Last Updated
February 4, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02925663
Brief Title
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
Official Title
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
executive functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients are receiving an executive functioning intervention in an open trial design-pre-post
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EFI-E
Arm Type
Experimental
Arm Description
10-session web-based modules to teach about executive functioning with videoconferencing with a therapist
Intervention Type
Behavioral
Intervention Name(s)
EFI-E
Intervention Description
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 Outcome Measure Information:
Title
Executive functioning: Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Adherence: SimpleMed Pillboxes or MEMS TrackCaps
Time Frame
3-months
Title
Quality of life: PedsQL Epilepsy Module
Time Frame
3-months
Title
Seizures
Description
A combination of chart review and parent-report will be used to create a composite seizure presence/absence variable.
Time Frame
3-months
Other Pre-specified Outcome Measures:
Title
Child behavioral and emotional functioning: Behavior Assessment Schedule for Children-2
Time Frame
3-months
Title
Treatment Feasibility
Description
Treatment Feasibility and Acceptability Questionnaire
Time Frame
3-months
Title
Executive functioning-BRIEF
Time Frame
5-months
Title
Executive functioning-BRIEF
Time Frame
8-months
Title
Adherence-SImple Med Pillbox or MEMS TrackCaps
Time Frame
8-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35873364
Citation
Gutierrez-Colina AM, Clifford L, Wade SL, Modi AC. Uncovering Key Elements of an Executive Functioning Intervention in Adolescents: Epilepsy Journey. Clin Pract Pediatr Psychol. 2022 Jun;10(2):150-163. doi: 10.1037/cpp0000410. Epub 2021 Sep 2.
Results Reference
derived
Learn more about this trial
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
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