Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Sep 20, 2024

Keywords

ClinConnect Summary

The "Epilepsy Journey" clinical trial is exploring how effective a web-based program and telehealth therapy sessions are in helping teenagers with epilepsy improve their executive functioning skills, which are important for tasks like planning, organizing, and decision-making. The trial will see which parts of the program—either the online modules, the therapist sessions, or a combination of both—are most beneficial. Eligible participants are teenagers aged 13 to 17 who have a confirmed diagnosis of epilepsy and experience challenges with executive functioning.

During the trial, participants will spend about 15-30 minutes weekly on online modules and have telehealth sessions with a therapist for 30-45 minutes over 14 weeks. They'll complete surveys to assess their executive functioning and quality of life at the start of the study and again after several weeks. The trial is currently recruiting participants and aims to gather valuable information on how to best support teens with epilepsy in managing their condition and improving their daily lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 13-17 years at the time of enrollment
• • 2. Child lives at home with primary caregiver and is enrolled in school (excluding summer breaks).
• • 3. 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.
• • 4. Primary language of English
• • 5. 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).
• • 6. Parent/legal guardian(s) willing to sign an IRB approved informed consent
• • 7. Participant willing to sign an Institutional Review Board approved assent
• Exclusion Criteria:
• 1. Parent or clinician-reported history in the adolescent of:
• • 1. 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)
• • 2. 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)
• • 3. prior (3-months) or current history of trauma and/or stressor-related disorders (e.g. PTSD)
• • 4. recent or current significant medical disease (i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic or endocrine)
• • 5. brain injury or brain tumor; and/or
• • 6. epilepsy surgery
• • 7. any other medical and/or psychological condition that takes treatment precedence over the study intervention
• • 2. Clinician-reported diagnosis in the adolescent of
• • 1. epilepsy whose seizures are categorized only as either unknown onset or unclassified onset (defined as insufficient information to determine onset)
• • 2. epilepsy currently being treated at the time of enrollment by 3 or more antiseizure medications (ASMs) (excluding rescue medication use)
• • 3. epilepsy with a history of failure to achieve seizure freedom despite adequate use of 4 different anti-seizure medications
• • 4. a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome)
• • 5. a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders)
• • 6. one or more episodes of status epilepticus within the 24 weeks prior to enrollment; and/or
• • 7. treatable causes of seizures, for example identified etiologies including metabolic, neoplastic, or active infectious origin.
• • 8. non-epileptic event/seizures
• • 3. Adolescents currently on the ketogenic diet
• • 4. Participation in a trial of an investigational drug or device within 30 days prior to screening