Introduction Insomnia affects up to 80% of children with autism spectrum disorder (ASD). Negative consequences of insomnia in ASD include decreased quality of life (QOL), impaired learning and cognition, increased stereotypic and challenging behaviours, and increased parental stress. Cognitive behavioural treatment for childhood insomnia (CBT-CI) is a promising treatment for dealing with insomnia and its negative consequences but has not yet been studied in school-aged children with ASD and comorbid insomnia. Access to healthcare is another challenge for children with ASD, particularly in rural and underserved regions. Previous studies indicate that ASD and insomnia share common arousal-based underpinnings, and we hypothesise that CBT-CI will reduce the hyperarousal associated with insomnia and ASD. This trial will be the first to examine CBT-CI adapted for children with ASD and will provide new information about two different modes of delivery across a variety of primary and secondary child and parent sleep and related outcomes. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target childhood insomnia and ASD.
Methods and analysis Children (N=180) 6–12 years of age with ASD and insomnia will be recruited from an established autism database, a paediatric clinic and community outreach in the Columbia, MO and surrounding areas. Participants will be randomised to CBT-CI adapted for children with ASD (in-person or remote using computers with cameras) or Sleep Hygiene and Related Education. Participants will be assessed at baseline, post-treatment, 6-month and 12-month follow-ups. The following assessments will be completed regarding the children: objective and subjective sleep, daytime functioning (adaptive functioning, attention, challenging behaviours, anxiety), QOL and physiological arousal (heart rate variability) and parents: objective and subjective sleep, daytime functioning (anxiety, depression, fatigue), QOL, physiological arousal and parental burden/stress.
Ethics and dissemination Ethics approval was obtained in January 2020 from the University of Missouri. Ethics approval was obtained in July 2020 from the US Army Medical Research and Development Command, Office of Research Protections and Human Research Protection Office. All data are expected to be collected by 2024. Full trial results are planned to be published by 2025. Secondary analyses of baseline data will be subsequently published.
Trial registration number NCT04545606; Pre-results.
- child & adolescent psychiatry
- sleep medicine
- sleep medicine
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Contributors All authors made substantial contributions to the concept and design of the study. CM, MM, AFC and NN drafted initial protocol, with input from all authors. CD and AFC drafted statistical analysis plan. CM, MM, DB, KS and ZN drafted screening procedures. DB, KS, BED and ZN drafted referral procedures. CD, MG, NN and AFC conducted initial data processing. CM and MS drafted the manuscript. CM, MS, MG and BED revised the manuscript. All authors reviewed and approved the revised manuscript.
Funding This work is supported by the Department of Defense (DOD) USAMRAA Congressionally Directed Medical Research Programmes, Autism Research Programme, Clinical Trial Award with grant number CTA AR190047 and award number W81XWH2010399.
Disclaimer The study sponsor was not actively responsible or involved in the study design and will have no involvement in collection, management, analysis or interpretation of data. The sponsor will have no involvement in future manuscript preparation and decision to submit for publication. This research was done using previous patient involvement in the pilot study. Patients were invited to comment on the study design and indicated that less sessions were preferable. In response, the current RCT was reduced from 8 sessions (as found in the pilot) to 4 sessions. Patients were not invited to contribute to the writing or editing of this document for readability or accuracy.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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