Changing Agendas on Sleep, Treatment and Learning in Childhood Epilepsy (CASTLE)

Patient and Public Involvement We prepared this proposal with two parents (co-applicants), and organised a family consultation event. We have engaged three charities as PPI and dissemination partners. A children s and a parents advisory panel will advise on the research, and two members from each panel will join the Programme Management Group. Aims and Objectives This programme aims to improve outcomes for children with rolandic epilepsy by asking what impact different treatment policies have on their health and quality-of-life. (1) identifying a core set of outcome measures reflecting health and quality-of-life that are meaningful to families; (2) understanding and describing how concerns around drug treatment, learning and sleep problems influence decisions about management; (3) tailoring and evaluating an intervention to ameliorate sleep problems in childhood epilepsy; (4) evaluating the effectiveness and cost-effectiveness of drug-based seizure management and/or behavioural sleep interventions with regard to medical, learning, and patient-centred outcomes. Background and Rationale Epilepsy affects 1% of the population, mostly arises in childhood, and costs the NHS £2 billion annually. Seizures are not the principal determinant of quality-of-life for children or parents, although seizures are the traditional focus of management. Older and newer antiepileptic drugs impair learning and the benefits over non-treatment are not fully established. Sleep disturbance is also a major comorbidity that may affect learning and quality of life. We will investigate the effectiveness of two different drugs versus no-treatment and/or parent-based sleep (PBS) interventions. We will study rolandic epilepsy (RE) as an exemplar because it is the most common type, the balance of drug benefit against side effects is at equipoise, nocturnal seizures are usual, sleep disturbance triggers seizures, and sleep problems are common. Research Plan This ambitious but achievable five year programme of integrated workpackages: WP1 (year 1-2) selects a core outcome set for evaluative research for children with RE, which will be used in WP4. WP2 (year 2-5) develops a qualitative evidence base to inform and support the choices and decisions that parents and their children with epilepsy make in relation to the management of RE. WP3 (year 1) tailors existing Parent-Based Sleep (PBS) interventions into an e-learning package (e-PBS) for children with epilepsy, and is deployed and evaluated in WP4. WP4 (year 2-5) is a factorial design pragmatic randomised trial comparing no-drug treatment vs (standard) carbamazepine vs (new) levetiracetam, with either e-PBS intervention or standard care. Dissemination and Projected Outputs In addition to scientific outputs, we will work with charities Epilepsy Action, Epilepsy Society and Cerebra, and relevant professional groups (Royal College of Paediatrics and Child Health, Epilepsy Specialist Nurses Association) to disseminate the key messages in plain language summaries to families, professional groups, managers, commissioners and policy-makers. We plan to deliver the most important outputs within a maximum of three to five years. We will deliver two outputs during the programme: (1) a new core outcome set for evaluative research in Year 2; and (2) a new online e-PBS intervention for children with epilepsy also in Year 2. Trial publications will follow soon after the programme, with specific policy recommendations for the NHS about (3) treatment vs no-treatment, (4) carbamazepine vs levetiracetam, and (5) sleep intervention in rolandic epilepsy within 3-5 years. Most of the output will be (6) generalizable to other common childhood epilepsies either immediately or within 5 years of the programme end. Relevant expertise and experience of the research team The team includes internationally respected clinicians and academics from paediatric neurology, sleep medicine and behavioural psychology, health services rese