Improving executive functioning in teens with epilepsy through a web-based intervention

Epilepsy Journey 2.0: An Intervention to Improve Executive Functioning in Adolescents With Epilepsy

This study is testing a new online program to see if it can help teenagers with epilepsy improve their thinking skills and overall quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 13 Years to 17 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (other)
• Locations: 3 sites (Orange, California and 2 other locations)
• Trial ID: NCT06608966 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a web-based intervention called Epilepsy Journey, designed to enhance executive functioning in adolescents with epilepsy. Participants aged 13-17 will be randomly assigned to one of four groups: receiving both web-based modules and telehealth sessions, web-based modules only, telehealth sessions only, or standard treatment. The study will assess which components of the intervention are most effective in improving executive functioning and quality of life. The trial addresses a significant gap in interventions for this vulnerable population, as deficits in executive functioning are prevalent among youth with epilepsy.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 13-17 with a confirmed diagnosis of epilepsy and identified executive functioning deficits.

Not a fit: Patients who do not have executive functioning deficits or are outside the age range of 13-17 may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve executive functioning and overall quality of life for adolescents with epilepsy.

How similar studies have performed: Previous studies have shown promising results with similar behavioral interventions, indicating potential for success in this approach.

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

Where this trial is running

Orange, California and 2 other locations

• Childrens Hospital of Orange County — Orange, California, United States (RECRUITING)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Avani Modi, Ph.D. — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Avani C Modi, Ph.D.

Conditions: Epilepsy in Children, Executive Dysfunction, adolescents, executive functioning, seizures, epilepsy, behavioral trial, web-based intervention