title: Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project.
abstract: BACKGROUND
  Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN68819261. ISRCTN: ISRCTN68819261.
authors.affiliation: Centre for Community Child Health, Murdoch Childrens Research Institute, Royal Children’s Hospital, Flemington Road, Parkville, Victoria, Australia.
authors.forename: Emma
authors.initials: E
authors.lastname: Sciberras
authors.forename: Daryl
authors.initials: D
authors.lastname: Efron
authors.forename: Bibi
authors.initials: B
authors.lastname: Gerner
authors.forename: Margot
authors.initials: M
authors.lastname: Davey
authors.forename: Fiona
authors.initials: F
authors.lastname: Mensah
authors.forename: Frank
authors.initials: F
authors.lastname: Oberklaid
authors.forename: Harriet
authors.initials: H
authors.lastname: Hiscock
mesh_terms: D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D000203:Activities of Daily Living; D001288:Attention; D001289:Attention Deficit Disorder with Hyperactivity / Q000503:physiopathology / Q000628:therapy; D001521:Behavior Therapy / Q000379:methods; D005178:Faculty; D005500:Follow-Up Studies; D008570:Memory, Short-Term; D010290:Parents; D007319:Sleep Initiation and Maintenance Disorders / Q000503:physiopathology / Q000628:therapy; D011795:Surveys and Questionnaires / Q000592:standards; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic