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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 3-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 8 sessions, over 4 months (6 face-to-face, 2 phone). Families in treatment will be followed for 3 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 the current 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 of patients with epilepsy and their caregivers (n= 40) will be utilized to identify important content areas based on their personal experiences. Qualitative data analysis of focus groups combined with input from experts in the field of pediatric epilepsy will be used to develop items for the pilot measure. Pretesting and cognitive interviewing (n = 20) will be used to refine the instrument until resolution of issues has occurred.
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 the current study is to examine adherence over time to AED therapy using objective electronic monitors and identify predictors of non-adherence in adolescents with epilepsy. Fifty adolescents and their primary caregivers will be recruited during routine epilepsy clinic visits to participate in the current study. Adolescents and their caregivers will complete questionnaires at routine clinic visits, which occur every 3 months, and have their electronic monitors downloaded at each visit for approximately one year. Through the study we hope to examine adherence in adolescents with epilepsy over the one-year study period. We hope to identify predictors of adherence over time. It is our expectation that 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) will be significant 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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