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Title

Multicentre randomised controlled trial of digital parent-guided sleep intervention (Sleep Buddy) versus usual care in children aged 6-12 years with ADHD and chronic insomnia.

Description

The aim of this study is to see if our new website Sleep Buddy, can help parents/carers of children aged 6-12 years with a diagnosis of ADHD, to improve their child’s sleep.

Sleep Buddy was developed by parents and carers of children with ADHD working with sleep experts. It has personalised information and advice on how primary caregivers can manage their child’s sleep problems with videos and top tips from other parents. The website will help primary caregivers to create a sleep plan to help their child’s sleep.

Objectives

Primary:

• To determine whether, in addition to usual care, the use of a parent-guided sleep intervention reduces mean sleep onset latency at 3 months and 6 months post-randomisation in children with ADHD and chronic insomnia.

Secondary:

• To assess the effect of the intervention on secondary outcomes including ADHD symptom severity, behavioural and emotional functioning, wider subjective sleep variables, cognitive variables, quality of life, and parental well-being.
• A within-trial cost-effectiveness analysis and decision model to estimate long-term costs and quality-adjusted life years for the digital intervention versus usual care.
• A nested process evaluation to assess mechanisms of change and to inform implementation planning.

Trial Design

The study will last for 6 months, and over 300 people will take part.

The study can be completed online. Parents or carers taking part will be put into one of two groups. One group will have access to the Sleep Buddy website for 6 months. The other group will not, but will continue to receive the health care and support that they have always been given.

At the start of the study, both groups will be asked to fill out a short sleep diary online every morning for 10 Days. They will also complete some questionnaires online and some with a study researcher on video chat. The child will be invited to complete some computer-based attention and memory tasks, which are like games, with the support of one of our researchers. All participants will complete the sleep diary, questionnaires and tasks at month 3 and month 6.

Trial Status

Open to recruitment

Population

334 Primary Caregivers and their child aged 6-12 (inclusive) with ADHD, experiencing chronic insomnia.

Funder

Ìý

This trial is funded by the National Institute for Health and Care ResearchÌýProgramme Grants for Applied Research (PGfAR)Ìý-ÌýNIHR203684