Clinical trial for Epilepsy in Children
Official title Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
ClinicalTrials.gov ID: NCT06608966
What this study is testing
- What it's testing
- The study wants to see which parts of the program – web‑based modules, therapist video sessions, or both – help teens with epilepsy improve executive functioning and quality of life.
- Who it's for
- Teenagers with epilepsy who have difficulties with executive functioning.
- What's involved
- Participants will spend 15‑30 minutes on online lessons and/or have a 30‑45‑minute video call with a therapist each week for 14 weeks, and they will complete surveys about thinking skills and quality of life at several time points.
- Time commitment
- The study lasts about 66 weeks, with weekly online activities for 14 weeks and follow‑up assessments at 14, 26, and 66 weeks.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 17
You may be able to join if
- 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.
- Primary language of English
- Screening Inclusion: On the parent-reported Behavior Rating Inventory of Executive Function-2nd edition (BRIEF-2), have executive functioning...
You likely can't join if
- developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual...
- severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months, depression with active suicidal ideation or...
- 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
See the full eligibility 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
- 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...
- Parent/legal guardian(s) willing to sign an IRB approved informed consent
- Participant willing to sign an Institutional Review Board approved assent
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Orange, California, United States
- Cincinnati, Ohio, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orange, California, United States; Cincinnati, Ohio, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.