Completed Projects

Supporting Treatment Adherence Regimens: The STAR Trial
(R01HD073115; Supporting Treatment Adherence Regimens in Pediatric Epilepsy)

Obtaining and maintaining complete seizure freedom is compromised by the high rate of non-adherence to antiepileptic drug (AED) therapy, documented in 58% of children with new-onset epilepsy during their first six months of therapy. AED non-adherence is associated with continued seizures, a three-fold risk for mortality and high healthcare costs. Thus, improving pediatric AED 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 AED adherence in children.

The purpose of this study was to test the efficacy of an adherence intervention addressing pediatric AED nonadherence. Two hundred newly diagnosed patients and their families were recruited during routine epilepsy clinic visits to participate in the current study. Participants were either monitored over time or randomized into one of two groups. Those randomized to treatment participated in eight sessions over four months (six face-to-face, two phone). Families in treatment were followed for three additional time points after treatment ends. Recruitment for this study ended in December 2018. We are currently analyzing this data and hope to publish our findings in 2020. Our methods paper was recently published.

Epilepsy Journey
(R21HD083335-01; Web-based Intervention to Improve Executive Functioning in Teens with Epilepsy)

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, which is 3 times the prevalence in healthy youth. 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 vulnerable population.

The aim of the study was to develop an individually-tailored intervention to improve EF in adolescents with epilepsy (Epilepsy Journey) through an iterative, patient-centered process that includes: 1) identification of the unique needs of adolescents with epilepsy and their families based on focus group feedback (Phase 1), and 2) usability testing of a revised intervention protocol to elicit feedback on the applicability, content, and individualized approach (Phase 2). Our primary outcomes from this study have been published and we are examining our secondary outcomes currently.

Learn more about this research from Dr. Modi.

Neuroimaging biomarkers for executive functioning in adolescents with epilepsy (fMRI study)

Despite medical advances in the treatment of seizures, adolescents with epilepsy often have poor behavioral outcomes, and demonstrate poor adherence to the medical treatment. Deficits in executive functioning skills (i.e. problem-solving, initiation, planning/organization, monitoring, self-regulation and working memory) likely underlie these poor outcomes. Executive function deficits are common in youth with epilepsy and are a strong predictor of long-term neurobehavioral problems in children with seizures.

In this study, we used neuroimaging in adolescents with epilepsy to establish a biomarker for executive function deficits in this population. We collected structural and functional neuroimaging data approximately 40 adolescents with epilepsy and 20 healthy controls in the same age range. We are analyzing abnormalities in specific brain networks that have been suggested to underlie executive function in healthy children and adults. We are also evaluating multi-method measurement of EF using neuropsychological testing, questionnaires, and imaging. Overall, our goal is to understand the neural basis of these deficits to facilitate improved prediction of who will benefit from EF interventions. Several papers and posters have been published from this study.

Validation of the PedsQL™ Epilepsy Module

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 include 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.  Visit this website to obtain these instruments.

Text-messaging & Adherence Pilot Study (TAPS Study)

The purpose of the study was to test the feasibility and acceptability of five different text-messaging or application based interventions to improve adolescent AED non-adherence. Twenty-five families were randomized to one of five interventions: 1) adolescent text only, 2) adolescent and caregiver text plus communication, 3) adolescent application only, 4) adolescent and caregiver application plus communication, and 5) epilepsy application for adolescents only. Primary caregivers and adolescents completed baseline assessment measures, as well as post-treatment and follow-up assessments. Patients were followed for approximately 3-months. The primary outcome measure was electronically-monitored adherence using MEMS TrackCaps or a SimpleMed. Data have been published.

Adolescent Adherence to Antiepileptic Drugs Study: The AAA Study

Few studies have been conducted with adolescents with epilepsy to examine rates, patterns, and predictors of non-adherence to AED therapy using objective methods (i.e., electronic monitors). The purpose of this study was to examine adherence over time to AED therapy using objective electronic monitors and identify predictors of non-adherence in adolescents with epilepsy. Sixty adolescents and their primary caregivers completed questionnaires and had their adherence monitored over the course of one year. We are working on examining the data and are interested in identifying individual (e.g., internalizing/externalizing problems, risk-taking, treatment responsibility, self-management behaviors), family (e.g., conflict), medical (e.g., side effects, seizure), and sociodemographic variables (e.g., socioeconomic status, age) predictors of adherence over one-year. Several papers and posters have been published from these data.

Adherence and Barriers in Children with Epilepsy: The ABC Study

The ABC study, which was completed in 2011, focused on examining patterns of adherence rates over time for children with new-onset epilepsy and identifying the factors that best predict adherence to antiepileptic drug therapy for children with epilepsy over time. We recruited 124 participants, who used electronic monitors, to assess adherence over time and completed questionnaires to assess psychosocial variables (e.g., barriers, knowledge, parenting stress, family functioning, child psychopathology) over 10 time points. Findings from this longitudinal dataset have been published and presented at various regional and national conferences.