Clinical trial NCT06608966: Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy
Official title: Epilepsy Journey 2.0: An Intervention to Improve Executive Functioning in Adolescents With Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy in Children
Executive Dysfunction
Keywords: adolescents
executive functioning
seizures
epilepsy
behavioral trial
web-based intervention
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Children's Hospital of Orange County
name: University of Georgia
name: University of Iowa
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-09-23
Enrollment: 310
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The proposed study will involve a multi-center randomized controlled clinical trial using a factorial design to simultaneously assess the impact of two behavioral treatment components: 1) Epilepsy Journey web-based modules and 2) Epilepsy Journey telehealth sessions with a therapist.There are four treatment arms for the current study, including 1) Epilepsy Journey web-based modules, 2) Epilepsy Journey web-based modules and telehealth with a therapist, 3) Telehealth with a therapist, and 4) Treatment as Usual.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Epilepsy is a common pediatric neurological condition affecting \~470,000 youth in the United States. Adolescents with epilepsy are at significant risk for neurobehavioral comorbidities (i.e., depressive/behavioral symptoms) and suboptimal social, academic, and quality of life outcomes. Research suggests that deficits in executive functioning (EF), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation and working memory, contribute to suboptimal functioning. EF deficits have been documented in up to 50% of youth with epilepsy, which is 3 times the prevalence in healthy youth. Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes and promoting optimal functioning in adolescents with epilepsy; however none exists for this vulnerable population. To fill this gap, the investigators successfully developed and tested Epilepsy Journey (EJ), a comprehensive e-health behavioral multi-component problem-solving intervention that combines 10 self-guided learning modules with 10 telehealth sessions. The promising proof-of-concept trial (n=39) showed high feasibility, acceptability, patient satisfaction, and significant improvements in parent-reported EF behaviors, neurobehavioral functioning, and quality of life. The next logical phase of this research is to conduct a definitive randomized clinical trial to examine: whether the two components of treatment (EJ modules and telehealth) are 1) both essential and 2) have a durable impact on improving parent-reported and performance-based EF behaviors and quality of life. Thus, the aim of the current proposal is to conduct a multi-site Phase 3 randomized controlled clinical trial (RCT) using a 2x2 factorial design to examine the efficacy of separate (EJ modules and EJ telehealth) and combined components of EJ on EF. Participants positive for EF deficits (n=232) will be randomized to one of four arms: 1) EJ modules with telehealth sessions, 2) EJ modules alone, 3) EJ telehealth sessions alone, or 4) Usual Care (no EJ modules or telehealth sessions). Treatment participants will either independently review EJ modules focused on EF skills (\~15-30 min.) and/or have weekly telehealth sessions (\~30-45 min.) with a therapist for 14-weeks. The groups will learn and apply problem-solving strategies to their individual EF difficulties. Participants will complete measures at baseline, 14-, 26-, and 66- weeks after randomization to examine maintenance of effects. There is a critical need for evidence-based interventions to improve executive functioning behaviors in youth with epilepsy. If the aims of this study are achieved, we will have definitive evidence for addressing EF deficits. The investigators expect that EJ modules and EJ telehealth will demonstrate efficacy alone and in combination, which will allow patients to select the approach best suited to their specific situation. Consequently, we can improve long-term outcomes (e.g., neurobehavioral comorbidities, academic success, social relationships, and quality of life) in adolescents with epilepsy, a high-risk population.

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

Primary outcomes:
measure: Behavior Rating Inventory of Executive Function (2nd edition) Global Executive Composite T-score (parent)
timeFrame: 26-weeks post-randomization
Secondary outcomes:
measure: PedsQL™ Epilepsy Module - Impact Subscale (Adolescent report)
timeFrame: 26-weeks post-randomization
measure: PedsQL™ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)
timeFrame: 26-weeks post-randomization
measure: PedsQL™ Epilepsy Module - Executive Functioning Subscale (Adolescent report)
timeFrame: 26-weeks post-randomization
measure: PedsQL™ Epilepsy Module -Sleep Subscale (Adolescent report)
timeFrame: 26-weeks post-randomization
measure: PedsQL™ Epilepsy Module -Mood/Behavior Subscale (Adolescent report)
timeFrame: 26-weeks post-randomization
Other outcomes:
measure: Behavior Rating Inventory of Executive Function (2nd edition) -Global Executive Composite T-score (parent)
timeFrame: 66-weeks post-randomization
measure: PedsQL™ Epilepsy Module - Impact Subscale (Adolescent report)
timeFrame: 66-weeks post-randomization
measure: PedsQL™ Epilepsy Module - Cognitive Functioning Subscale (Adolescent report)
timeFrame: 66-weeks post-randomization
measure: PedsQL™ Epilepsy Module - Executive Functioning Subscale (Adolescent report)
timeFrame: 66-weeks post-randomization
measure: PedsQL™ Epilepsy Module -Sleep Subscale (Adolescent report)
timeFrame: 66-weeks post-randomization
measure: PedsQL™ Epilepsy Module -Mood/Behavior Subscale (Adolescent report)
timeFrame: 66-weeks post-randomization
measure: NIH Cognition Toolbox: Fluid Cognition Composite
timeFrame: 26-weeks post-randomization
Locations:
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Avani Modi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: