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P66 Multicentre randomised controlled trial (RCT) of digital parent guided sleep intervention (sleep buddy) versus usual care in children aged 6-12 years with ADHD and chronic insomnia: a protocol

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Introduction Sleep problems are reported in up to 73% of children with ADHD. Limited specialist NHS resources and a lack of structured training for health professionals and accessible relevant support for parents means these are frequently inadequately managed leading to poorer outcomes for children with ADHD.Sleep Buddy is a digital intervention co-developed by sleep experts and parents/carers of children with ADHD. It has personalised information and evidence-based advice to support primary caregivers to improve their child’s sleep.Methods The parallel-arm multi-centre RCT will compare the effects of Sleep Buddy access compared to usual care on children’s sleep onset latency at 3 and 6 months. The aim is to recruit 334 children aged 6-12 with a diagnosis of ADHD who are experiencing sleep problems and their primary carers from NHS ADHD clinics, ADHD support groups, charities, social media, and foster care services across 4 research Hubs.The primary outcome will be children’s sleep onset latency at 3 and 6 months. Other secondary outcomes include child ADHD symptom severity, behavioural and emotional functioning, subjective sleep variables, cognitive variables, quality of life, parental well-being, and cost-effectiveness of the intervention.A nested process evaluation, including 15-20 qualitative interviews, will assess the mechanisms of change and to inform the implementation planning.Outcomes The internal pilot phase will evaluate our strategic approach to recruitment and retention and inform progression to the main phase. Initial recruitment figures and data will be presented.Discussion The DISCA trial findings evaluating the clinical and cost-effectiveness of the Sleep Buddy intervention will provide new high-quality evidence on the Sleep Buddy intervention to support children with ADHD and sleep problems.Acknowledgements Co-ordinated by the Southampton Clinical Trials Unit and sponsored by University Hospital Southampton NHS Foundation Trust. The Trial is Funded by NIHR Programme Grants for Applied Research.