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Sleeping sound with autism spectrum disorder (ASD): study protocol for an efficacy randomised controlled trial of a tailored brief behavioural sleep intervention for ASD
  1. Nicole Papadopoulos1,
  2. Emma Sciberras1,2,3,
  3. Harriet Hiscock2,4,
  4. Katrina Williams2,3,4,
  5. Jane McGillivray1,
  6. Cathrine Mihalopoulos1,
  7. Lidia Engel1,
  8. Matthew Fuller-Tyszkiewicz1,
  9. Susannah T Bellows1,
  10. Deborah Marks1,4,
  11. Patricia Howlin5,6,
  12. Nicole Rinehart1
  1. 1Deakin University, Geelong, Victoria, Australia
  2. 2Murdoch Children's Research Institute, Parkville, Victoria, Australia
  3. 3Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia
  4. 4The Royal Children’s Hospital, Parkville, Victoria, Australia
  5. 5Brain and Mind Centre, University of Sydney, Camperdown, New South Wales, Australia
  6. 6Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
  1. Correspondence to Dr Nicole Papadopoulos; nicole.papadopoulos{at}deakin.edu.au

Abstract

Introduction Sleep problems are a characteristic feature of children with autism spectrum disorder (ASD) with 40% to 80% of children experiencing sleep difficulties. Sleep problems have been found to have a pervasive impact on a child’s socio-emotional functioning, as well as on parents’ psychological functioning. The Sleeping Sound ASD project aims to evaluate the efficacy of a brief behavioural sleep intervention in reducing ASD children’s sleep problems in a fully powered randomised controlled trial (RCT). Intervention impact on child and family functioning is also assessed.

Methods and analysis The RCT aims to recruit 234 children with a diagnosis of ASD, aged 5–13 years, who experience moderate to severe sleep problems. Participants are recruited from paediatrician clinics in Victoria, Australia, and via social media. Families interested in the study are screened for eligibility via phone, and then asked to complete a baseline survey online, assessing child sleep problems, and child and family functioning. Participants are then randomised to the intervention group or treatment as usual comparator group. Families in the intervention group attend two face-to-face sessions and a follow-up phone call with a trained clinician, where families are provided with individually tailored behavioural sleep strategies to help manage the child’s sleep problems. Teacher reports of sleep, behavioural and social functioning are collected, and cognitive ability assessed to provide measures blind to treatment group. The primary outcome is children’s sleep problems as measured by the Children’s Sleep Habits Questionnaire at 3 months post-randomisation. Secondary outcomes include parent and child quality of life; child social, emotional, behavioural and cognitive functioning; and parenting stress and parent mental health. Cost-effectiveness of the intervention is also evaluated.

Ethics and dissemination Findings from this study will be published in peer-reviewed journals and disseminated at national and international conferences, local networks and online.

Trial registration number ISRCTN14077107 (ISRCTN registry dated on 3 March 2017).

  • autism spectrum disorder
  • ASD
  • sleep
  • behavioural sleep intervention
  • RCT

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors NR, NP, ES, HH, KW, JM, PH and CM conceived the study. STB, DM and LE contributed to the writing of the methods and intervention for the study. NP and STB drafted the manuscript. MF-T contributed to the design and analytical components of the study. All authors contributed, read and approved the final manuscript.

  • Funding This work was supported by the Australian National Health and Medical Research Council (NHMRC; project grant no APP1101989). ES is funded by an NHMRC Career Development Fellowship 1110688 (2016-21) and a veski Inspiring Women Fellowship. HH is supported by an NHMRC Practitioner fellowship 1136222 (2018-2022). The Murdoch Children's Research Institute is supported by the Victorian Government’s Operational Infrastructure Support Program.

  • Competing interests NP, NR and JM receive philanthropic funding from the Moose Foundation, Ferrero Group Australia as part of its Kinder + Sport pillar of Corporate Social Responsibility initiatives, MECCA Brands, Wenig Family, Geelong Community Foundation, and Grace & Emilio Foundation; and industry partner funding from the Victorian Department of Education, to conduct research in the field of neurodevelopmental disorders and inclusion. NP, NR and JM have also previously received funding from the Australian Foortball Leagure and industry partner funding from the NDIS. NR has received donations form Vic Health and Bus Assoication Victoria; and previously received speaker honorarium from Novartis (2002), Pfzier (2006) and Nutricia (2007); and is a Director of the Amaze Board (Autism Victoria). None of the companies or organisational bodies listed above had a role in this research including the collection, analysis and interpretation of data; in writing of the manuscript; and /or in the decision to submit the article for publication.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.