Actively Recruiting
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-04-25
310
Participants Needed
3
Research Sites
220 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions: 1. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving executive functioning in adolescents with epilepsy? 2. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving quality of life in adolescents with epilepsy? Participants will be randomly assigned to one of four groups: 1) Epilepsy Journey web-based modules and telehealth sessions, 2) Epilepsy Journey web-based modules only, 3) telehealth sessions with a therapist only, or 4) treatment as usual. Participants will: * Independently review Epilepsy Journey web-based modules focused on executive functioning skills (\~15-30 minutes) and/or have weekly telehealth sessions (\~30-45 minutes) with a therapist for 14 weeks. * Complete measures of executive functioning (parent and teen-report) and quality of life (teen-report) at the start of the study, 14-, 26-, and 66- weeks after randomization. The NIH toolbox will be completed at the start of the study and 26-weeks after randomization. Additional measures will also be collected.
CONDITIONS
Official Title
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 13 and 17 years at enrollment
- Lives at home with a primary caregiver and is enrolled in school (excluding summer breaks)
- Confirmed diagnosis of epilepsy with seizures categorized as generalized or focal onset
- Primary language is English
- Executive functioning deficits identified by parent-reported Behavior Rating Inventory of Executive Function-2nd edition (BRIEF-2) scores
- Parent or legal guardian willing to provide informed consent
- Participant willing to provide assent
You will not qualify if you...
- History of developmental delay, including autism spectrum disorder or intellectual impairment (IQ <70)
- History of severe mental illness such as schizophrenia, bipolar disorder, or recent depression with suicidal thoughts
- History of trauma or stressor-related disorders in past 3 months
- Recent or current serious medical diseases affecting major organs or systems
- Brain injury, brain tumor, or epilepsy surgery
- Any medical or psychological condition that requires treatment over study intervention
- Epilepsy with unknown or unclassified seizure onset
- Epilepsy currently treated with 3 or more anti-seizure medications
- History of failure to control seizures despite adequate use of 4 different anti-seizure medications
- Confirmed or suspected epileptic encephalopathy or progressive degenerative disorders
- One or more episodes of status epilepticus within 24 weeks before enrollment
- Treatable seizure causes such as metabolic, neoplastic, or infectious origins
- Non-epileptic seizures
- Currently following a ketogenic diet
- Participation in another investigational drug or device trial within 30 days prior to screening
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Childrens Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
A
Avani C Modi, Ph.D.
CONTACT
S
Stacy Buschhaus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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