Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E: a protocol for a randomised controlled trial comparing an online behavioural sleep intervention with standard care in children with Rolandic epilepsy.

INTRODUCTION: Sleep and epilepsy have an established bidirectional relationship yet only one randomised controlled clinical trial has assessed the effectiveness of behavioural sleep interventions for children with epilepsy. The intervention was successful, but was delivered via face-to-face educational sessions with parents, which are costly and non-scalable to population level. The Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E trial addresses this problem by comparing clinical and cost-effectiveness in children with Rolandic epilepsy between standard care (SC) and SC augmented with a novel, tailored parent-led CASTLE Online Sleep Intervention (COSI) that incorporates evidence-based behavioural components. METHODS AND ANALYSES: CASTLE Sleep-E is a UK-based, multicentre, open-label, active concurrent control, randomised, parallel-group, pragmatic superiority trial. A total of 110 children with Rolandic epilepsy will be recruited in outpatient clinics and allocated 1:1 to SC or SC augmented with COSI (SC+COSI). Primary clinical outcome is parent-reported sleep problem score (Children's Sleep Habits Questionnaire). Primary health economic outcome is the incremental cost-effectiveness ratio (National Health Service and Personal Social Services perspective, Child Health Utility 9D Instrument). Parents and children (≥7 years) can opt into qualitative interviews and activities to share their experiences and perceptions of trial participation and managing sleep with Rolandic epilepsy. ETHICS AND DISSEMINATION: The CASTLE Sleep-E protocol was approved by the Health Research Authority East Midlands (HRA)-Nottingham 1 Research Ethics Committee (reference: 21/EM/0205). Trial results will be disseminated to scientific audiences, families, professional groups, managers, commissioners and policymakers. Pseudo-anonymised individual patient data will be made available after dissemination on reasonable request. TRIAL REGISTRATION NUMBER: ISRCTN13202325.

Vocal brain development in infants of mothers with serious mental illness (CAPRI-Voc): study protocol.

INTRODUCTION: Improving the lives of children and adolescents with parental mental illness (CAPRI) remains an urgent political and public health concern for the UK and European Union. Recurrent parental mental illness is believed to lead to fractures in the family, academic and social lives of these children, yet interventions are poorly targeted and non-specific. Part of an interdisciplinary programme of work (the CAPRI Programme; grant number: 682741), CAPRI-Voc aims to achieve two goals: first, to test the feasibility of our longitudinal imaging paradigm in mother-infant pairs where the mother has a diagnosis of severe mental illness. Second, to compare development of vocal processing in these infants with infants in the general population. METHODS AND ANALYSIS: Recruitment of 100 infants of mothers with mental illness, alongside 50 infants of healthy mothers. Both cohorts of infants will undergo functional near infrared spectroscopy (fNIRS) brain imaging at three time points: 9, 12 and 18 months to explore differences between cohorts in their neural responses to vocal stimuli in our language paradigm. Mothers will complete an interview and psychological questionnaires. We shall also complete an infant developmental battery and mother-child interaction play session. Data on recruitment, retention and dropout will be recorded. ETHICS AND DISSEMINATION: It will be made clear that fNIRS is a safe, non-invasive technology widely used in infant clinical and psychological research. We shall reassure mothers that no definitive causal link exists between maternal mental illness and language development in infants, and that individual data will only exist as part of the wider dataset. As the study includes both children and vulnerable adults, all research staff will complete National Health Service (NHS) Safeguarding level 3 training. Dissemination will be via direct feedback to stakeholders, patient and advisory groups, and through presentations at conferences, journal publications and university/NHS trust communications. The study was approved through North West-Greater Manchester West Research Ethics Committee (17/NW/0074) and Health Research Authority (212715).