Novel Adherence Measurement and Intervention in Children with New-Onset Epilepsy

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DESCRIPTION (provided by applicant): The K23 Candidate is an assistant professor in the Division of Behavioral Medicine and Clinical Psychology at Cincinnati Children's Hospital Medical Center (CCHMC). This K23 application combines mentoring in neurology, pharmacology, and behavioral psychology that relates to adherence of antiepileptic drug therapy (AED) in children with new-onset epilepsy. The proposed career development plan will provide the candidate necessary training in the use of pharmacokinetic modeling of AED serum levels needed to develop an objective biological marker of adherence and training in the development of clinical intervention trials to improve adherence. Training in these areas is needed to develop reliable outcome measures of adherence and implement an evidence-based intervention to improve adherence. The candidate's career plan capitalizes on the expertise at CCHMC to augment prior and planned training in the behavioral aspects of adherence in pediatric epilepsy. In addition, the commitment of the candidate's division related to at least 75 percent protected research time during her early faculty appointment and resources available (e.g., computers, office space) make CCHMC an ideal institution for such an award. The candidate thus proposes a five-year program of intensive mentorship and training by nationally renowned clinical investigators, courses related to pharmacokinetic modeling and therapeutic drug monitoring, longitudinal design and statistical analyses, clinical trials methodology, grant writing skills, and research ethics. The proposed research plan consists of three major aims. The first aim of the study is to validate an objective, biological marker of adherence by measuring the association between the difference (e.g., residual) of PK predicted AED serum concentrations and observed serum concentrations and electronically monitored adherence. The second aim of the study is to identify valid targets for intervention based on a conceptual model that identifies disease/regimen, parent, and child factors associated with poor adherence. Finally, information obtained from Aims 1 (objective marker of adherence) and 2 (targets for intervention) will be utilized to develop, refine, and manualize a behavioral intervention to improve adherence in children with new-onset epilepsy. The combined skill set and experience garnered from the candidate's career development and research plans will provide the necessary early career support for the candidate to establish a successful independent research career in the area of adherence in pediatric epilepsy. Relevance to Public Health: Pediatric epilepsy affects 325,000 children. The candidate's success has significant relevance to public health as the design of effective adherence interventions could improve both health outcomes and quality of life for children with epilepsy and their families.