Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
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.
Inclusion Criteria:
- 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 Criteria:
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
BEHAVIORAL: Epilepsy Journey web-based modules, BEHAVIORAL: Telehealth with a therapist
Epilepsy in Children, Executive Dysfunction
adolescents, executive functioning, seizures, epilepsy, behavioral trial, web-based intervention