This paper is a protocol. It describes the plan for a trial called Sleeping Sound with ADHD, not its results. The trial was set up to test a brief behavioural sleep program for children who have ADHD. The program would be given by paediatricians or psychologists in normal clinic settings, rather than in a research lab.
The study planned to include 320 children aged 5 to 12 years. Each child had ADHD diagnosed by a paediatrician and confirmed with DSM-5, plus a moderate or severe sleep problem. Families were recruited through paediatrician practices in Victoria and Queensland, Australia.
Because this is a protocol, it reports no findings about whether the program helped. The team does explain how it chose the sample size. It started from an earlier efficacy trial and assumed the program would create a 20% gap between groups (56% versus 36%). That called for 107 children per group, or 214 in total. The number was then raised to allow for the study design (a factor of 1.2) and for 20% of families dropping out, reaching 320.
The authors note some limits to the plan. The trial only includes English-speaking families. It leaves out children with serious medical conditions or intellectual disability. Sleep problems are judged by parents, who know which group their child is in, and not by objective measures.
Source: Sciberras E, Mulraney M, Heussler H, et al.. Does a brief, behavioural intervention, delivered by paediatricians or psychologists improve sleep problems for children with ADHD? Protocol for a cluster-randomised, translational trial. BMJ Open (2017). doi:10.1136/bmjopen-2016-014158
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