Web-Based Program for Teens with Epilepsy

Recruiting at 2 trial locations

Overseen By Stacy Buschhaus

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Antiseizure medications

Disqualifiers: Developmental delay, Severe mental illness, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 44

Duration: 14 weeks

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a web-based program, called Epilepsy Journey, can improve thinking skills and quality of life for teens with epilepsy. Participants will engage with different parts of the program: completing online modules, having sessions with a therapist, both, or continuing their usual care. It suits teens diagnosed with epilepsy who face challenges with daily tasks and decision-making. The goal is to determine which parts of the program are most helpful. As an unphased trial, this study offers teens a unique opportunity to contribute to innovative research that could enhance their daily lives.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, if you are currently being treated with three or more anti-seizure medications, you may not be eligible to participate.

What prior data suggests that this web-based program is safe for teens with epilepsy?

Research shows that the "Epilepsy Journey" online modules are safe and easy to use. Past studies have demonstrated improvements in mental skills like planning and attention, with no safety issues reported. These modules focus on executive functioning, which includes skills like organizing and planning, and are important for teens with epilepsy.

Studies indicate that telehealth sessions with a therapist are generally safe and helpful. Telehealth improves access to specialized epilepsy care and often enhances patient outcomes. No significant problems have been reported from these sessions.

Using both the online modules and telehealth sessions together also appears safe. Both methods aim to support mental skills and quality of life for teens with epilepsy without introducing new risks.

In summary, research shows that both the online modules and telehealth sessions are safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Program for Teens with Epilepsy because it offers a unique approach by combining digital learning and telehealth. Unlike traditional treatments that primarily focus on medication, this program empowers teens with epilepsy to manage their condition through interactive web-based modules, which can be accessed anytime, anywhere. The addition of optional telehealth sessions with a therapist provides personalized support, making it a flexible and comprehensive approach to managing epilepsy. This innovative method could lead to improved self-management and quality of life for teens, which is why it's generating enthusiasm among researchers.

What evidence suggests that this trial's treatments could be effective for improving executive functioning and quality of life in adolescents with epilepsy?

Studies have shown that the Epilepsy Journey online modules can enhance crucial mental skills, such as time management and attention, in teenagers with epilepsy. Research indicates that these modules are well-received and show promise in helping teens manage their symptoms more effectively. In this trial, some participants will receive only the Epilepsy Journey modules, while others will receive the modules combined with telehealth sessions, where a therapist provides personal guidance. The benefits of combining the modules with telehealth appear even greater. Additionally, some participants will receive only telehealth sessions, which have also proven helpful, making it easier for patients to access care and improving overall outcomes for those with epilepsy. Overall, early findings suggest that both the online program and telehealth sessions could positively impact the lives of teens dealing with epilepsy. ^{1 2 3 6 7}

Who Is on the Research Team?

Avani Modi, Ph.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for teens with epilepsy who struggle with executive functioning, which includes skills like planning and organization. They should be willing to use web-based modules or attend telehealth sessions. Specific eligibility details are not provided, so it's assumed that participants must meet certain health criteria set by the study.

Inclusion Criteria

Primary language of English

On the parent-reported BRIEF-2, have executive functioning deficits defined as at least 2 subclinical (60<T<65) or one clinical BRIEF subscale T scores (T≥65)

Parent/legal guardian(s) willing to sign an IRB approved informed consent

Exclusion Criteria

Parent or clinician-reported history in the adolescent of 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)

Participation in a trial of an investigational drug or device within 30 days prior to screening

I have a significant health condition like heart, liver, kidney, or hormonal issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in Epilepsy Journey web-based modules and/or telehealth sessions with a therapist focused on executive functioning for 14 weeks

14 weeks

Weekly telehealth sessions (30-45 minutes each)

Follow-up

Participants are monitored for maintenance of effects on executive functioning and quality of life

52 weeks

Assessments at 14, 26, and 66 weeks post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Epilepsy Journey

Trial Overview The 'Epilepsy Journey' intervention is being tested to see if its web-based modules or therapist-led telehealth sessions can improve executive functioning and quality of life in adolescents with epilepsy. Participants will be randomly placed into one of four groups, including a control group receiving usual treatment.

How Is the Trial Designed?

Group I: Telehealth with a therapist alone Experimental Treatment 1 Intervention

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

Group II: Epilepsy Journey web-based modules alone Experimental Treatment 1 Intervention

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 III: Epilepsy Journey web-based modules + telehealth with a therapist Experimental Treatment 2 Interventions

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 IV: Treatment as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Children's Hospital of Orange County

Collaborator

Trials

38

Recruited

5,700+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Digital and mobile platforms for epilepsy self-management offer constant accessibility, making it easier for patients to manage their condition anytime and anywhere.

These platforms are rapidly scalable and cost-effective compared to traditional in-person programs, potentially increasing access to care for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management in Epilepsy Care: Untapped Opportunities. Ozuna, J., Kelly, P., Towne, A., et al.[2020]

The study involved eight children aged 7-11 with childhood absence epilepsy (CAE) who used a mobile cognitive therapy app for 4 weeks, averaging 78 minutes of use per week, indicating the intervention's feasibility.

Both children and parents reported high satisfaction with the app, and while the study did not primarily focus on efficacy, some improvements were observed in processing speed and fluid intelligence tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Mobile Cognitive Intervention in Childhood Absence Epilepsy. Glynn, P., Eom, S., Zelko, F., et al.[2020]

In a study of 940 people with epilepsy, the most common adverse drug reactions (ADRs) reported were nervousness (34.3%), aggression (33.6%), and weight gain (32.3%), highlighting the need for careful monitoring of these side effects.

The duration of anti-seizure medication use and the length of time a person has had epilepsy were identified as key factors influencing the likelihood of experiencing ADRs, suggesting that healthcare providers should focus on these aspects to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and associated factors with adverse drug reaction in people with epilepsy. Ogunjimi, L., Alabi, A., Aderinola, A., et al.[2023]

The Pediatric Epilepsy Outcome-Informatics Project (PEOIP) at Alberta Children's Hospital has successfully collected standardized epilepsy data from 3,245 unique patients over 5 years, demonstrating the feasibility of point-of-care data entry in routine clinical practice.

Surveys indicated high satisfaction among providers and families, with 86% of families finding the standardized electronic note valuable for improving communication and care coordination, highlighting its potential to enhance quality of care for children with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation and implementation of an electronic health record note for quality improvement in pediatric epilepsy: Practical considerations and lessons learned. Buchhalter, JR., Scantlebury, MH., D'Alfonso, S., et al.[2022]

Participants in the WebEase online program showed significantly higher medication adherence compared to those in the waitlist control group, indicating the program's effectiveness in supporting epilepsy management.

Completing WebEase modules was associated with increased self-efficacy and improvements in perceived stress and self-management, suggesting that engaging with the program can enhance overall management of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a research study evaluating WebEase, an online epilepsy self-management program. DiIorio, C., Bamps, Y., Walker, ER., et al.[2019]

The Web-based program 'Epilepsy Journey' was found to be feasible and acceptable for 31 adolescents with epilepsy, with 79% completing the program and high satisfaction ratings from both caregivers and participants.

Participants showed significant improvements in executive function behaviors, with notable reductions in deficits reported by caregivers, indicating that the program may effectively enhance executive function skills in adolescents with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy Journey: A proof of concept trial of a Web-based executive functioning intervention for adolescents with epilepsy. Modi, AC., Mara, CA., Schmidt, M., et al.[2020]

The Epilepsy Journey program, developed through focus groups with adolescents and caregivers, aims to improve executive functioning in youth with epilepsy by addressing issues like memory, attention, and organization through ten tailored learning modules.

Usability testing showed that participants found the program user-friendly and helpful, with high perceived utility, indicating it is a promising intervention that will be further tested in a pilot study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a web-based executive functioning intervention for adolescents with epilepsy: The Epilepsy Journey. Modi, AC., Schmidt, M., Smith, AW., et al.[2018]

The SMART self-management program significantly reduced negative health events (NHEs) in adults with epilepsy, showing an odds ratio of 3.2 compared to a wait-list group, based on a 6-month randomized controlled trial with 120 participants.

Improvements in self-management, quality of life, and reductions in depression symptoms were found to mediate about 20-30% of the program's effectiveness in reducing NHEs, highlighting the importance of addressing mental health and quality of life in epilepsy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a remotely delivered group-format epilepsy self-management program on adverse health outcomes in vulnerable people with epilepsy: A causal mediation analysis. Briggs, FBS., Wilson, BK., Pyatka, N., et al.[2021]

The web-based intervention 'Epilepsy Journey' showed significant improvements in emotional and behavioral functioning among 39 adolescents with epilepsy, as reported by caregivers, particularly in externalizing symptoms and adaptive skills over a 5-month follow-up period.

Participants also reported enhanced health-related quality of life, including improvements in mood, cognitive functioning, and sleep, suggesting that this gamified approach may effectively support adolescents with executive functioning deficits related to epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Executive Functioning Intervention in Epilepsy: Behavioral and Quality of Life Outcomes. Modi, AC., Mara, CA., Schmidt, M., et al.[2022]

The My Epilepsy Diary application allows patients to track their seizures and antiepileptic drug (AED) use, providing valuable data for personalized management, with 1944 users contributing demographic information and 1877 logging seizure data.

Among the 70,990 seizure entries recorded, 82% of users were on multiple AEDs, and mood-related side effects were reported by 19% of users, highlighting the importance of monitoring both seizure activity and medication effects in epilepsy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online diary for tracking epilepsy. Le, S., Shafer, PO., Bartfeld, E., et al.[2011]

In a study of 100 patients with epilepsy, the most common adverse effects reported from antiepileptic drugs were sleepiness, memory problems, and difficulty concentrating, with higher adverse effects associated with polytherapy and female gender.

The Liverpool Adverse Events Profile (LAEP) showed strong reliability and internal consistency, indicating it is a useful tool for assessing the impact of antiepileptic drugs on patients' quality of life and mental health, correlating well with anxiety and depression scales.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are adverse effects of antiepileptic drugs different in symptomatic partial and idiopathic generalized epilepsies? The Portuguese-Brazilian validation of the Liverpool Adverse Events Profile. Martins, HH., Alonso, NB., Vidal-Dourado, M., et al.[2022]

The WebEase program, a 6-week Internet-based self-management tool for adults with epilepsy, was found to be feasible, acceptable, and user-friendly, as reported by the 35 participants involved in the pilot study.

Participants showed improvements in key areas such as epilepsy self-management, medication adherence, sleep quality, self-efficacy, and social support, suggesting that WebEase could effectively support individuals in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of WebEase: an epilepsy self-management Web site. DiIorio, C., Escoffery, C., McCarty, F., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06608966

Epilepsy Journey-An Executive Functioning Intervention for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6778683/

Epilepsy Journey: A proof of concept trial of a web-based ... The current study was a proof of concept trial of a novel, web-based executive functioning intervention, Epilepsy Journey, for adolescents with epilepsy.

3. cincinnatichildrens.org cincinnatichildrens.org/research/divisions/c/adherence/labs/modi/projects

Modi Lab Projects Epilepsy Journey 2.0 is a phase 3 randomized controlled trial (RCT) designed to assess the impact of both behavioral treatment components (EJ modules and EJ ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505017301440

Development of a web-based executive functioning ... The aims of the current study were to develop an individually-tailored intervention, called Epilepsy Journey, to improve aspects of EF through an iterative, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/epi.16317

Epilepsy Journey: A proof of concept trial of a Web‐based ... To examine the preliminary feasibility and acceptability of a Web-based program, Epilepsy Journey, to improve executive function behaviors in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31423591/

Epilepsy Journey: A Proof of Concept Trial of a Web ... - PubMed Objective: To examine the preliminary feasibility and acceptability of a Web-based program, Epilepsy Journey, to improve executive function behaviors in ...

7. withpower.com withpower.com/trial/phase-epilepsy-in-children-10-2024-b7fca

Web-Based Program for Teens with Epilepsy The Epilepsy Journey program, a web-based intervention, has shown promise in improving executive function (mental skills like planning and attention) in ...