Clinical and Cost-Effectiveness of an Online Parent-Directed Behavioural Sleep Intervention in addition to Standard Care for Sleep Problems in Children with Epilepsy in the UK: the CASTLE Sleep-E Multicentre, Randomised Controlled Trial

ObjectivesSleep problems are common in children with epilepsy. We aimed to evaluate the clinical effectiveness and incremental cost-effectiveness of an online resource for parents of children with epilepsy (CASTLE Online Sleep Intervention, or COSI) combined with standard care (SC) versus SC alone over six months. DesignWe conducted a multicentre, parallel-group, unblinded, randomised controlled trial with an internal pilot. Setting26 UK NHS paediatric epilepsy outpatient clinics. ParticipantsChildren aged 4-12 years with clinician-confirmed epilepsy and caregiver-reported sleep problems. InterventionsParticipants were randomly assigned (1:1) via a computer-generated minimisation algorithm to SC or SC plus COSI. Main outcome measuresThe primary outcome, assessed at three months, was the Childrens Sleep Habits Questionnaire (CSHQ). Cost-effectiveness was estimated at six months, with utilities from the Child Health Utility 9-Dimensions Index and costs from an NHS and Personal Social Services perspective. Safety analyses included all randomised participants. Analyses were performed on an intention to treat basis. Results85 children were enrolled between 30.08.2022 and 18.10. 2023, (42 SC; 43 SC+COSI). At three months, the adjusted mean CSHQ difference between SC+COSI and SC was 3.00 (95% CI 0.06-5.93; p=0.05), indicating no significant superiority. No adverse events were reported. Children in the SC+COSI group showed a mean 16.5-minute reduction in sleep onset latency and parents increased their knowledge. Only 23 (53%) families accessed the core online materials. Incremental mean cost of SC+COSI was {pound}1,232 (95% credibility interval {pound}535-{pound}3,455) with a mean incremental QALY of 0.00 (95% CI -0.03 to 0.04), yielding an incremental cost-effectiveness ratio of {pound}433,167 per QALY gained a (0.04 probability of being cost-effective at the {pound}30,000/QALY threshold). ConclusionsAn online Parent-Directed Behavioural Sleep Intervention did not reduce parent-rated sleep problems in children with epilepsy in the NHS context. However, improved objective sleep onset latency and enhanced parental knowledge suggest that the underlying behaviour change techniques have merit. Blended delivery through specialist nurses or similar support may improve engagement and outcomes. Trial registrationISRCTN13202325. FundingNIHR Programme Grant for Applied Research RP-PG-0615-20007.