Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and poor treatment adherence. Studies have shown that one potential reason for these poor outcomes are 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.

EF deficits have been documented in 1/3 of youth with epilepsy. Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and promoting optimal functioning in adolescents with epilepsy; however, none exists for this population.

Epilepsy Journey 1.0 was a foundational project focused on developing the Epilepsy Journey intervention. In phase 1, we identified the needs of adolescents with epilepsy and conducted usability testing on e-health intervention components. In phase 2, we conducted a proof-of-concept trial with 31 adolescents with epilepsy and EF deficits that completed the EJ program (web modules paired with telehealth sessions). Results indicated significant improvements in EF, quality of life, and neurobehavioral outcomes, along with high levels of family satisfaction.

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 telehealth) separately and combined on improving EF skills in adolescents with epilepsy. We aim to enroll 310 adolescents and their caregivers across three collaborating sites: Cincinnati Children’s, Medical University of South Carolina, and Children’s Hospital of Orange County.

Eligible participants are administered a survey to screen and identify adolescents at risk for EF deficits. Participants that screen positive for EF deficits will continue with the trial and be randomized into one of four groups:

1. Modules only
2. Telehealth only
3. Modules and Telehealth
4. Usual care

Primary and secondary outcomes include parent-reported executive functioning and adolescent-reported quality of life. This data will be analyzed to determine which intervention components are most effective in improving these outcomes. We are actively recruiting participants for the RCT.

Epilepsy Journey 2.0: An Intervention to Improve Executive Functioning in Adolescents With Epilepsy

Non-adherence to anti-seizure medications (ASMs) is a common problem (i.e., 58% of patients have some level of non-adherence) for young children with newly diagnosed epilepsy, with potentially devastating consequences. ASM non-adherence is associated with a 3-fold increased risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher healthcare utilization and costs.

One of the primary barriers to adherence is forgetting, which may be particularly amenable to mHealth (mobile technology in healthcare) interventions. Despite the critical need to develop and implement interventions to improve adherence, there are few family-based interventions for young children with epilepsy and their families.

The aim of this sequential, multiple-assignment, randomized trial (SMART) was to evaluate the effectiveness of mHealth intervention strategies for improving ASM adherence in parents/legal guardians of young children with epilepsy using a stepped-up care model. We recruited 466 participants who used electronic adherence monitors (e.g., pillbox or pill bottle) and completed questionnaires. Only participants who demonstrate adherence <95% during baseline were randomized to either the control group or treatment groups. Primary and secondary outcomes included electronically monitored adherence, seizure severity, seizure freedom, and quality of life. The methods for this project have been published. Data from this project is currently being analyzed, and will be published soon.

Fostering Medication Adherence in Children with Epilepsy Using mHealth Technology

Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. T1D treatment adherence is challenging, especially during adolescence, which can lead to suboptimal blood glucose levels that severely compromises health, and in some cases, leads to premature death.

Several interventions for adolescents with T1D exist, but none have focused on adherence barriers. The Barriers to Diabetes Adherence scale assesses these important targets for tailored adherence interventions, including stress/burnout and time pressure/planning (e.g., skills related to executive functioning). These adherence barriers are significantly associated with non-adherence, higher glycemic levels, and lower quality of life; however, no interventions address these two barriers in research or clinical practice.

The aim of this multi-site study was to develop and evaluate how Diabetes Journey (based on Epilepsy Journey 1.0) helps to improve stress/burnout and time pressure/planning (e.g., executive functioning) in adolescents with T1D. We recruited 195 participants that were randomized to either receive Diabetes Journey or an enhanced standard of care. Primary and secondary outcomes included adherence barriers, adherence, glycemic control, and quality of life. The methods for this project have been published. Data from this project is currently being analyzed, and will be published soon.

Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents with Type 1 Diabetes

There are no efficacious adherence interventions for adolescents with epilepsy. This gap is remarkable as low motivation and susceptibility to peer influence make adolescents more likely to engage in behaviors that have immediate rewards, especially in the context of their peers (e.g., skipping ASMs when out with friends), and less likely to worry about future negative consequences (e.g., having a seizure).

Not surprisingly, adherence worsens during adolescence, further increasing the risk of poor health outcomes during this developmental period. However, leveraging social norms comparison methods (i.e., feedback about someone else’s behavior related to one’s own behavior) from behavioral economics offers a unique opportunity to capitalize on the increased importance of peer influence, while simultaneously targeting the low motivation characteristic of adolescents.

The aim of this study was to evaluate the feasibility, acceptability, and preliminary efficacy of a social norms mHealth adherence intervention in adolescents with epilepsy. We recruited 104 participants that were either randomized to the social norms mHealth treatment group or control group. Primary and secondary outcomes included intervention feasibility and acceptability, ASM adherence, seizure severity, and quality of life. Data from this project has been published.

BEAT: Improving Drug Adherence Using mHealth and Behavioral Economics in Teens with Epilepsy

Children and adolescents with epilepsy are at risk for poor health related quality of life (HRQOL). Generic measures of HRQOL may not capture unique aspects of functioning in this population, which are necessary for gauging clinical outcomes and response to treatment. Current epilepsy-specific HRQOL measures, which are responsive to the disease and its treatments, have significant limitations, including no self-report and parent-proxy versions for certain ages (e.g., self-report for 2–10-year-olds, parent-proxy report for 2-4 year-olds), no parent-proxy and self-reports developed in parallel, or exclusion of individuals with cognitive impairments.

The aim of this project was to develop an epilepsy-specific HRQOL measure that includes self-report and parent proxy versions that can be used across the developmental spectrum. Focus groups and cognitive interviews with patients with epilepsy and their caregivers identified important content areas based on their personal experiences as well as ways to refine the measures. We then tested the draft measures of the PedsQL™ Epilepsy Module across five epilepsy centers in the US, including Cincinnati Children’s, Medical University of South Carolina, University of Wisconsin, Children’s Hospital of Orange County, and Cook Children’s Hospital. The national validation sample includes 430 youth with epilepsy and their caregivers. Psychometric analyses revealed a strong measure with reliable scales: Impact, Cognitive, Sleep, Executive Functioning, and Mood/Behavior. Self-report versions were created for youth 5-7, 8-12, 13-17, and 18-25 years of age. Parent-proxy versions were created for caregivers of youth 2-4, 5-7, 8-12, 13-17, and 18-25 years of age.

Submit a Request for the PedsQL™ Epilepsy Module

Obtaining and maintaining complete seizure freedom is compromised by the high rate of non-adherence to anti-seizure medications (ASMs) therapy, documented in 58% of children with new-onset epilepsy during their first six months of therapy. ASM non-adherence is associated with continued seizures, a three-fold risk for mortality and high healthcare costs. Thus, improving pediatric ASM non-adherence is of utmost importance. Despite the critical need to develop and implement interventions to improve adherence, no methodologically rigorous randomized controlled trial (RCT) has focused on improving ASM adherence in children.

The purpose of this study was to test the efficacy of an adherence intervention addressing pediatric ASM non-adherence. Two hundred newly diagnosed patients and their families were recruited during routine epilepsy clinic visits to participate in the study. Participants were either monitored over time or randomized into one of two treatment groups: education only (EO) or STAR. Those randomized to STAR participated in six face-to-face and two phone sessions, for a total of eight sessions, over four months. Families in treatment were followed for three additional time points after treatment ended. Primary and secondary outcomes included adherence, seizure outcomes, and HRQOL. Data from this project has been published.

Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial

Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities, and poor treatment adherence. Studies have shown that one potential reason for these poor outcomes are 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.

EF deficits have been documented in 1/3 of youth with epilepsy, which is three 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.

The aim of the study was to develop an individually-tailored intervention (Epilepsy Journey) to improve EF in adolescents with epilepsy through an iterative, patient-centered process that included two phases: (1) Identification of the unique needs of adolescents with epilepsy and their families based on focus group feedback, and (2) Usability testing of a revised intervention protocol to elicit feedback on the applicability, content, and individualized approach. Data from this project has been published, and phase 3 is currently in progress (see Epilepsy Journey 2.0).

Web-based Intervention to Improve Executive Functioning in Teens with Epilepsy