Status:
RECRUITING
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Medical University of South Carolina
Children's Hospital of Orange County
Conditions:
Epilepsy in Children
Executive Dysfunction
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
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 epile...
Detailed Description
Epilepsy is a common pediatric neurological condition affecting \~470,000 youth in the United States. Adolescents with epilepsy are at significant risk for neurobehavioral comorbidities (i.e., depress...
Eligibility Criteria
Inclusion
- Age between 13-17 years at the time of enrollment
- Child lives at home with primary caregiver and is enrolled in school (excluding summer breaks).
- Confirmed diagnosis of epilepsy with seizures that are categorized as either generalized or focal in onset. Epilepsy is defined as: 1) At least two unprovoked seizures occurring more than 24-hours apart; or 2) One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures.
- Primary language of English
- Screening Inclusion: On the parent-reported Behavior Rating Inventory of Executive Function-2nd edition (BRIEF-2), have executive functioning deficits defined as at least 2 subclinical (60\<T\<65) or one clinical BRIEF-2 subscale T scores (T≥65).
- Parent/legal guardian(s) willing to sign an IRB approved informed consent
- Participant willing to sign an Institutional Review Board approved assent
Exclusion
- Parent or clinician-reported history in the adolescent of:
- developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ\<70)
- severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months, depression with active suicidal ideation or suicidal ideation/intent in the past 3 months)
- prior (3-months) or current history of trauma and/or stressor-related disorders (e.g. PTSD)
- recent or current significant medical disease (i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic or endocrine)
- brain injury or brain tumor; and/or
- epilepsy surgery
- any other medical and/or psychological condition that takes treatment precedence over the study intervention
- Clinician-reported diagnosis in the adolescent of
- epilepsy whose seizures are categorized only as either unknown onset or unclassified onset (defined as insufficient information to determine onset)
- epilepsy currently being treated at the time of enrollment by 3 or more antiseizure medications (ASMs) (excluding rescue medication use)
- epilepsy with a history of failure to achieve seizure freedom despite adequate use of 4 different anti-seizure medications
- a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome)
- a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders)
- one or more episodes of status epilepticus within the 24 weeks prior to enrollment; and/or
- treatable causes of seizures, for example identified etiologies including metabolic, neoplastic, or active infectious origin.
- non-epileptic event/seizures
- Adolescents currently on the ketogenic diet
- Participation in a trial of an investigational drug or device within 30 days prior to screening
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06608966
Start Date
November 11 2024
End Date
January 31 2029
Last Update
April 25 2025
Active Locations (3)
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1
Childrens Hospital of Orange County
Orange, California, United States, 92868
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425