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

Trial Summary

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 data supports the effectiveness of the treatment Epilepsy Journey 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 adolescents with epilepsy, as indicated by pilot studies that reported positive changes in emotional and behavioral functioning and quality of life. ^{1 2 3 4 5}

Is the Web-Based Program for Teens with Epilepsy safe for humans?

There is no specific safety data available for the Web-Based Program for Teens with Epilepsy under the names provided. However, similar web-based self-management programs for epilepsy, like WebEase, have been found to be acceptable and easy to use, with no reported safety concerns. ^{6 7 8 9 10}

How is the Epilepsy Journey treatment different from other treatments for epilepsy?

Epilepsy Journey is unique because it is a web-based program specifically designed to improve executive function (mental skills like planning and organizing) in teens with epilepsy, offering a convenient and accessible alternative to traditional in-person therapies. ^{1 3 4 11 12}

What is the purpose of this trial?

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.

Research Team

Avani Modi, Ph.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Epilepsy Journey: A proof of concept trial of a Web-based executive functioning intervention for adolescents with epilepsy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Development of a web-based executive functioning intervention for adolescents with epilepsy: The Epilepsy Journey. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot Executive Functioning Intervention in Epilepsy: Behavioral and Quality of Life Outcomes. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Mobile Cognitive Intervention in Childhood Absence Epilepsy. [2020]

5. United States 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. [2022]

6. Netherlands 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

An online diary for tracking epilepsy. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors and associated factors with adverse drug reaction in people with epilepsy. [2023]

9. United States 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of WebEase: an epilepsy self-management Web site. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Self-Management in Epilepsy Care: Untapped Opportunities. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Results of a research study evaluating WebEase, an online epilepsy self-management program. [2019]