Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy

NCT ID: NCT06608966

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2029-01-31

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.

Conditions

Epilepsy in Children; Executive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epilepsy Journey web-based modules alone

Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules. Participants will be targeted to complete 10 EJ modules (\~15-30 minutes each session) within 14 weeks.

Group Type: EXPERIMENTAL

Epilepsy Journey web-based modules

Intervention Type: BEHAVIORAL

Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules focused on executive functioning skills. The modules cover 10 topic areas: Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Participants will complete 10 modules (\~15-30 minutes each session) within a 14-week time frame. The goal is to complete one module per week.

Epilepsy Journey web-based modules + telehealth with a therapist

Participants will receive both the Epilepsy Journey web-based modules and telehealth sessions with a therapist weekly. Participants will review 10 modules independently (\~15-30 minutes) and complete 10 telehealth sessions (\~30-45 minutes each session) within a 14-week time frame.

Group Type: EXPERIMENTAL

Epilepsy Journey web-based modules

Intervention Type: BEHAVIORAL

Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules focused on executive functioning skills. The modules cover 10 topic areas: Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Participants will complete 10 modules (\~15-30 minutes each session) within a 14-week time frame. The goal is to complete one module per week.

Telehealth with a therapist

Intervention Type: BEHAVIORAL

Therapist will cover 10 areas of executive functioning during telehealth sessions, including Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Telehealth sessions with a therapist will occur via HIPAA-compliant videoconference (e.g. Microsoft Teams) each week ideally over the course of 14 weeks.

Telehealth with a therapist alone

Participants will meet with a therapist for 10 telehealth sessions (30-45 minutes each session) within a 14-week time frame.

Group Type: EXPERIMENTAL

Telehealth with a therapist

Intervention Type: BEHAVIORAL

Therapist will cover 10 areas of executive functioning during telehealth sessions, including Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Telehealth sessions with a therapist will occur via HIPAA-compliant videoconference (e.g. Microsoft Teams) each week ideally over the course of 14 weeks.

Treatment as Usual

Participants will receive no active behavioral health treatment components and will be followed in usual epilepsy care for 14 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Epilepsy Journey web-based modules

Participants assigned to Epilepsy Journey modules will independently review web-based EJ modules focused on executive functioning skills. The modules cover 10 topic areas: Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Participants will complete 10 modules (\~15-30 minutes each session) within a 14-week time frame. The goal is to complete one module per week.

Intervention Type: BEHAVIORAL

Telehealth with a therapist

Therapist will cover 10 areas of executive functioning during telehealth sessions, including Positive Thoughts, Problem-Solving, Initiation, Working Memory, Monitoring, Inhibition, Emotional Control, Organization and Planning, Sleep/Stress, and a Wrap-Up. Telehealth sessions with a therapist will occur via HIPAA-compliant videoconference (e.g. Microsoft Teams) each week ideally over the course of 14 weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Children's Hospital of Orange County

OTHER

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Avani Modi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Childrens Hospital of Orange County

Orange, California, United States

Site Status: RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Avani C Modi, Ph.D.

Role: CONTACT

avani.modi@cchmc.org

513-636-4864

Stacy Buschhaus

Role: CONTACT

stacy.buschhaus@cchmc.org

513-636-3920

Facility Contacts

Heather Huszti, Ph.D.

Role: primary

hhuszti@choc.org

714-509-8481

Avani Modi, Ph.D.

Role: primary

avani.modi@cchmc.org

513-636-4864

Janelle Wagner, Ph.D.

Role: primary

wagnerjl@musc.edu

843-792-3307

Other Identifiers

UG3NS129558-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0297

Identifier Type: -

Identifier Source: org_study_id