Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project

This randomised controlled trial (RCT) is being conducted with 198 children (aged between 5 to 12 years) with ADHD and moderate to severe sleep problems. Children are recruited from public and private paediatric practices across the state of Victoria, Australia. Upon receiving informed written consent, families are randomised to receive either the behavioural sleep intervention or usual care. The intervention consists of two individual, face-to-face consultations and a follow-up phone call with a trained clinician (trainee consultant paediatrician or psychologist), focusing on the assessment and management of child sleep problems. The primary outcome is parent- and teacher-reported ADHD symptoms (ADHD Rating Scale IV). Secondary outcomes are child sleep (actigraphy and parent report), behaviour, daily functioning, school attendance and working memory, as well as parent mental health and work attendance. We are also assessing the impact of children's psychiatric comorbidity (measured using a structured diagnostic interview) on treatment outcome.To our knowledge, this is the first RCT of a behavioural intervention aiming to treat sleep problems in children with ADHD. If effective, this program will provide a feasible non-pharmacological and acceptable intervention improving child sleep and ADHD symptoms in this patient group.Current Controlled Trials ISRCTN68819261.ISRCTN: ISRCTN68819261Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common developmental disorders in childhood, affecting approximately 5% of children and adolescents [1]. ADHD is characterised by pervasive levels of inattention, impulsivity and/or hyperactivity, resulting in impairment in school and/or home settings [2]. In addition to the symptomatic burden on the child and consequences for families and schools, ADHD is associated with huge financial costs. In the United States, the estimated annual societal cost of ADHD in childhood and adolescence is US$42.5 billion [3]. The mainst