Article Text
Abstract
Introduction 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.
Methods and analysis 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 and dissemination 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.
Trial registration number ISRCTN50834814, Pre-results.
- attention deficit disorder with hyperactivity
- randomised controlled trial
- effectiveness
- treatment
- sleep
- child
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Footnotes
Contributors ES, HHe, HHi, NR and LG conceived the study. MM and NH coordinated the study. ES drafted the current manuscript. TS contributed to the design and analytic components of the study. All authors contributed, read and approved the final manuscript.
Funding This study is funded by the Australian National Health and Medical Research Council (NHMRC; project grant number 1058827). ES’ position is funded by an NHMRC Early Career Fellowship in Population Health 1037159 (2012–2015) and an NHMRC Career Development Fellowship 1110688 (2016–2019). HHi's position is funded by an NHMRC Career Development Fellowship 1068947 (2014–2017). This research was supported by the Victorian Government's Operational Infrastructure Support Program to the MCRI.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Granted ethics approval from The Royal Children's Hospital (34072), University of Queensland (2014001555), Mater Hospital (RG-14-349), Deakin University (2015-211), Victorian Department of Education and Training (2014_002519), The Queensland Department of Education and Training (550/27/1570) and the Catholic Education Office (Ballarat; Brisbane; Melbourne; Toowoomba) Human Research Ethics Committees.
Provenance and peer review Not commissioned; externally peer reviewed.