Executive Functioning Help for Teens with Epilepsy
Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Recruiting
N/AInterventional Study
Epilepsy in ChildrenExecutive Dysfunction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
13 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
310 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Who this trial is looking for
This trial is looking for teenagers with epilepsy to participate in a program aimed at improving their thinking skills. If you join, you will use online resources and have sessions with a therapist over 14 weeks.
Are You a Good Fit for This Trial?
Rules you outEpileptic encephalopathyProgressive and degenerative disordersNon-epileptic events/seizures
You may be able to join if
I am between 13 and 17 years old.
I live at home with a caregiver.
I am enrolled in school.
I have been diagnosed with epilepsy.
I speak English.
I have executive function difficulties.
My parent/guardian agrees to let me participate.
I am willing to participate.
You may not be able to join if
I have a developmental delay.
I have a severe mental illness.
I have had trauma-related disorders recently.
I have significant medical issues.
I have had brain surgery or have a brain injury.
I have specific types of epilepsy that are not eligible.
I am currently on a ketogenic diet.
I have participated in another study with new drugs in the past month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Whic…
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.
Trial Locations
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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 defi…
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
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