Sleeping sound with autism spectrum disorder (ASD): study protocol for an efficacy randomised controlled trial of a tailored brief behavioural sleep intervention for ASD

Abstract

IntroductionSleep 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 analysisThe 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 disseminationFindings from this study will be published in peer-reviewed journals and disseminated at national and international conferences, local networks and online.Trial registration number I SRCTN14077107 (ISRCTN registry dated on 3 March 2017).

Sleeping without Prescription: Management of Sleep Disorders in Children with Autism with Non-Pharmacological Interventions and Over-the-Counter Treatments

“…Parent sleep education has been found to be effective in the general pediatric population [17], and in small samples of children with ASD [26][27][28][29]. A 2017 meta-synthesis of previously published systematic reviews [30] showed that parent-based sleep education programs have strong positive effects on some sleep problems of children with ASD-specifically self-settling and night awakenings-and moderate or weak positive effects on all the other sleep domains.…”

Randomised Controlled Trial of a Behavioural Sleep Intervention, ‘Sleeping Sound’, for Autistic Children: 12-Month Outcomes and Moderators of Treatment

“…Chief investigators, members of the research team, and the statistician were blinded to participant group status to minimise potential bias. A detailed summary of the randomisation and blinding is outlined in our protocol paper (Papadopoulos et al, 2019 ) (Fig. 2 ).…”

“…To ensure treatment fidelity, study clinicians adhered to a standardised intervention manual and met fortnightly to discuss any clinical questions or issues. A detailed description of the Sleeping Sound intervention content is outlined in our protocol paper (Papadopoulos et al, 2019 ).…”

“…This paper focuses on the 12-month treatment effects to extend our previously published work (Papadopoulos et al, 2022 ). Our study protocol (Papadopoulos et al, 2019 ) proposed clustering by individual (Level 2) and paediatrician (Level 3). However, for most variables, the clustering effect for paediatrician did not significantly deviate from zero based on comparison of log likelihood values for models with and without random intercepts at Level 3.…”

Sleeping Sound Autism Spectrum Disorder (ASD): a randomised controlled trial of a brief behavioural sleep intervention in primary school‐aged autistic children

“…Required sample size was powered for a 0.5 standardised mean difference at 3 and 6 months postrandomisation for the primary outcome (a more conservative estimate than found in our pilot study), with alpha set at .05 (two tailed), power = .80, and allowances of 20% attrition due to loss of participants to follow-up and corrections in effective sample size attributable to clustering effects of individual and paediatrician (Papadopoulos, Sciberras, Hiscock, Williams, et al, 2019). On this basis, we aimed for 117 participants per group at baseline (234 children in total).…”