Title: Digital Sleep Support for Children with Attention-Deficit/Hyperactivity Disorder (The DISCA study)
Funder: Department of Health and Social Care

Abstract: Research question: Is a novel digital parent-guided behavioural intervention for chronic insomnia in children with Attention-Deficit/Hyperactivity Disorder (ADHD) significantly more cost-effective than treatment-as-usual (TAU) to improve sleep and relevant outcomes (e.g., child behaviour and parental well-being)? Background: ADHD affects about 3-6% of UK children, of whom up to 73% have sleep problems, increasing the burden of the disorder. In the UK, the commonest sleep problem in ADHD - chronic insomnia - is inadequately managed. Professionals rarely receive training in sleep and often prescribe melatonin as a one-size-fits all approach. Face-to-face behavioural sleep interventions are effective to manage insomnia in children with ADHD but their implementation is challenging in a resource-limited NHS. Aims and objectives: to appraise the evidence on the efficacy/effectiveness of behavioural sleep interventions in children (work package, WP1, months 0-12); to develop A) an adapted sleep screening questionnaire for children with ADHD and B) e-learning for clinicians on sleep problems in ADHD (WP2 months 0-18); to develop a novel digital behavioural intervention for chronic insomnia in children with ADHD (WP3, months 6-30); to test the cost-effectiveness of the digital behavioural intervention versus TAU in a randomised controlled trial (RCT) with a 9-month internal pilot (WP4, months 24-66). Methods: WP1: We will synthesise the evidence on non-pharmacological interventions for chronic insomnia in children through an umbrella review. WP2: Parents of 300 children with ADHD, aged 6-12y, will complete the Omnibus Sleep Questionnaire and the ADHD Swanson Nolan & Pelham Scale. An ADHD-specific sleep questionnaire will be generated, removing items with significant overlap between the questionnaires. Validity will be assessed using actigraphy in 150 children and test re-test reliability assessed. Supportive clinician e-learning tools will be co-produced with users within a Health E-Learning and Media centre. WP3: The novel digital parent-guided behavioural intervention will be developed with parents and carers, informed by WP1, using the Person-Based Approach and behavioural analysis, supported by Mindtech expertise (https://www.mindtech.org.uk/). WP4: Children with ADHD and chronic insomnia aged 6-12y and their families (n=334) will be recruited to a multicentre RCT from NHS clinics, foster care services, and parent support networks, sampling for under-represented populations. Children will be randomised 1:1 to digital intervention or TAU. The primary outcome - sleep onset latency, based on parent-completed sleep diaries- will be measured 3 and 6-months post-randomisation. Secondary outcomes will include ADHD symptom severity, behavioural and emotional functioning, neurocognitive variables, quality of life, and parental sleep and well-being. A within-trial cost-effectiveness analysis will be extended to model long-term costs and quality adjusted life years for the digital intervention versus TAU. WP5: Process evaluation will measure engagement with WP2 outputs and the digital intervention. Public and patient involvement will inform the development, conduct, evaluation, and dissemination of the programme. Anticipated impact and dissemination: Stakeholder involvement (e.g., professional bodies, parent support groups, local authorities, NHS commissioners and providers) will ensure rapid implementation of WP2 outputs - sleep questionnaire (host - https://www.acamh.org/) and clinician e-learning (host - https://www.nottingham.ac.uk/helm/home.aspx). A cost-effective digital intervention would be rapidly available at scale to 110,000 UK children.

Lay abstract: Aims: To help children with Attention Deficit Hyperactivity Disorder (ADHD) and sleep problems. Background: In the UK, at least 150,000 children between 6 and 12 years have ADHD. Around 3 in 4 of them have also sleep problems. Bad sleep makes daytime behaviour, schoolwork and quality of life worse. There are different types of sleep problems. Each needs a specific treatment. The most common sleep problem in children with ADHD is chronic insomnia. This means problems falling and staying asleep. Professionals who see children with ADHD are not taught much about sleep. They often prescribe medicines for sleep (e.g. melatonin) as a quick fix. Between 2015 and 2020 the NHS costs of melatonin in children rose from &pound;28 to &pound;39 million/year. Other treatments might work as well, or better. In Australia, 3 sessions of sleep advice provided face-to-face by a professional, improved chronic insomnia in children with ADHD. It also helped their behaviour. The NHS does not have enough people to do this. So, firstly we will help professionals know more about sleep problems in these children. We will then make a digital sleep guide for parents to use when their child with ADHD has chronic insomnia. Methods: We will first make a new questionnaire for professionals to check if children with ADHD have sleep problems. Parents of 300 children with ADHD will help us decide the best questions to ask. We will then make a guide on the internet for professionals to help them use the new questionnaire and understand sleep problems better. Next, we will develop a digital sleep guide for parents. We will read the best research to understand what helps sleep problems best. We will then work with different families, including foster carers, to make a user-friendly digital sleep guide. NHS technical experts will help us. We will check if the digital sleep guide works in 334 children with ADHD aged 6-12 years with chronic insomnia. Children will be put into 2 groups by chance: 167 will have the digital sleep guide and 167 will have normal NHS treatment. We will see if children who get the digital sleep guide sleep better, have better behaviour and quality of life than those who get usual treatment. We will check the costs for each group and how parents sleep and feel in the day. Patient and public involvement: We will have help from different families to make sure that what we make, the way we test it, and how we tell people about our research makes sense. Dissemination: We will work from the start with people who decide how things are run in the NHS, councils and ADHD charities to get our findings adopted across the UK.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: NEUROLOGICAL;MENTAL HEALTH