title: Does a brief, behavioural intervention, delivered by paediatricians or psychologists improve sleep problems for children with ADHD? Protocol for a cluster-randomised, translational trial.
abstract: Up to 70% of children with attention-deficit/hyperactivity disorder (ADHD) experience sleep problems. We have demonstrated the efficacy of a brief behavioural intervention for children with ADHD in a large randomised controlled trial (RCT) and now aim to examine whether this intervention is effective in real-life clinical settings when delivered by paediatricians or psychologists. We will also assess the cost-effectiveness of the intervention.
  
  
  
  Children aged 5-12 years with ADHD (n=320) are being recruited for this translational cluster RCT through paediatrician practices in Victoria and Queensland, Australia. Children are eligible if they meet criteria for ADHD, have a moderate/severe sleep problem and meet American Academy of Sleep Medicine criteria for either chronic insomnia disorder or delayed sleep-wake phase disorder; or are experiencing sleep-related anxiety. Clinicians are randomly allocated at the level of the paediatrician to either receive the sleep training or not. The behavioural intervention comprises 2 consultations covering sleep hygiene and standardised behavioural strategies. The primary outcome is change in the proportion of children with moderate/severe sleep problems from moderate/severe to no/mild by parent report at 3 months postintervention. Secondary outcomes include a range of child (eg, sleep severity, ADHD symptoms, quality of life, behaviour, working memory, executive functioning, learning, academic achievement) and primary caregiver (mental health, parenting, work attendance) measures. Analyses will address clustering at the level of the paediatrician using linear mixed effect models adjusting for potential a priori confounding variables.
  
  
  
  Ethics approval has been granted. Findings will determine whether the benefits of an efficacy trial can be realised more broadly at the population level and will inform the development of clinical guidelines for managing sleep problems in this population. We will seek to publish in leading international paediatric journals, present at major conferences and through established clinician networks.
  
  
  
  ISRCTN50834814, Pre-results.
authors.affiliation: Deakin Child Study Centre, School of Psychology, Deakin University, Geelong, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: E
authors.initials: E
authors.lastname: Sciberras
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Mulraney
authors.affiliation: Mater Research Institute-University of Queensland, South Brisbane, Queensland, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Heussler
authors.affiliation: Deakin Child Study Centre, School of Psychology, Deakin University, Geelong, Victoria, Australia.
authors.forename: N
authors.initials: N
authors.lastname: Rinehart
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
authors.forename: T
authors.initials: T
authors.lastname: Schuster
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Victoria, Australia.|Deakin Health Economics, Deakin University, Geelong, Victoria, Australia.
authors.forename: L
authors.initials: L
authors.lastname: Gold
authors.affiliation: Mater Research Institute-University of Queensland, South Brisbane, Queensland, Australia.
authors.forename: N
authors.initials: N
authors.lastname: Hayes
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.|The Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Hiscock
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology; D001521:Behavior Therapy / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D016000:Cluster Analysis; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008570:Memory, Short-Term / Q000502:physiology*; D008603:Mental Health; D011788:Quality of Life; D011793:Queensland / Q000453:epidemiology; D012893:Sleep Wake Disorders / Q000453:epidemiology / Q000209:etiology / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014739:Victoria / Q000453:epidemiology
keywords: attention deficit disorder with hyperactivity; child; effectiveness; randomised controlled trial; sleep; treatment