SLEEP : Intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: Study protocol for a randomised control trial

Introduction and objectives Children with attention deficit hyperactivity disorder (ADHD) have an increased risk of sleep problems. Weighted blankets are one possible non-pharmacological intervention for these problems in this group of children. However, the effectiveness of weighted blankets is insufficiently investigated. This study aims to investigate the effectiveness of weighted blankets in terms of sleep, health-related outcomes and cost-effectiveness as well as to explore children's and parents' experiences of a sleep intervention with weighted blankets. Methods and analysis This study is a randomised placebo-controlled crossover trial comparing the effect of weighted fibre blankets (active) with fibre blankets without weight (control). Children aged 6-13 years, recently diagnosed with uncomplicated ADHD with verified sleep problems, were included in the study. The study period is 4 weeks for each condition, respectively, and then an 8-week follow-up. A total of 100 children diagnosed with ADHD and sleep problems will enter the study. The primary outcomes are sleep and cost per quality-adjusted life years. The secondary outcomes are health-related quality of life, ADHD symptoms, psychological distress and anxiety. Interviews with a subsample of the participating children and parents will be conducted for exploring the experiences of the intervention. Ethics and dissemination Ethical approval of the trial has been obtained from the Swedish Ethical Review Authority (number 2019 - 2158) and conforms to the principles outlined in the Declaration of Helsinki (WMA, 2013). Results will be reported as presentations at peer-review conferences, in articles in peer-review journals and meetings with healthcare providers. Trial registration number NCT04180189