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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 current study is to develop an individually-tailored intervention to improve EF in adolescents with epilepsy (Executive Functioning Intervention-Epilepsy; EFI-E) 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). We plan to recruit 20 participants for Phases 1 and 2 of this study (Phase 1; n=6-10; Phase 2; n=6-10). We will then conduct an open trial of the final EFI-E intervention in 30 adolescents with epilepsy to determine its impact on executive functioning, adherence, and psychosocial outcomes. This project addresses the critical need for evidence-based interventions to improve EF, reduce neurobehavioral comorbidities, and improve AED non-adherence in a high risk epilepsy population.
Despite medical advances in the treatment of seizures, adolescents with epilepsy often have from poor behavioral outcomes, and demonstrate poor adherence to the medical treatment 6. 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 are a strong predictor of long-term neurobehavioral problems in children with seizures. In this study, we will use neuroimaging in adolescents with epilepsy to establish a biomarker for executive function deficits in this population. We will collect structural and functional neuroimaging data in 40 adolescents with epilepsy and 20 healthy controls in the same age range. We will focus on detecting abnormalities in specific brain networks that have been suggested to underlie executive function in healthy children and adults. In current standard of care, questionnaires and neuropsychological tests are used to assess EF; however, we propose that understanding the neural basis of these deficits will ultimately facilitate improved prediction of who will benefit from EF interventions.
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 health care 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 the current study is to test the efficacy of an adherence intervention addressing pediatric AED nonadherence. Two hundred newly diagnosed patients and their families will be recruited during routine epilepsy clinic visits to participate in the current study. Participants will either be monitored over time or be randomized (e.g., flip of a coin) into one of two group. Those randomized to treatment will participate in eight sessions, over four months (six face-to-face, two phone). Families in treatment will be followed for three additional timepoints after treatment ends.
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 is to develop an epilepsy specific module of the PedsQL 4.0, a widely used and highly validated HRQOL instrument, 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. Now we are undergoing national validation of the measure and hope this will be out for clinicians and researchers by 2017.
Non-adherence to medical regimens is a significant problem within pediatric populations that detrimentally impacts health and psychosocial outcomes. Approximately 60% of pediatric patients with epilepsy and their families are non-adherent to their antiepileptic drugs (AEDs). Poor AED adherence contributes to increased morbidity (i.e., persistent seizure activity), mortality, healthcare expenditures, and reduced quality of life for individuals with epilepsy. Few interventions have been developed to improve treatment adherence in adolescents with epilepsy. The purpose of the current 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 are currently being analyzed.
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 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.
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. We are currently analyzing and publishing key findings from this longitudinal dataset.
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