Better Night, Better Days for Children with Neurodevelopmental Disorders eHealth program: Protocol for an Economic Evaluation of a Randomized Controlled Trial (Preprint)

BACKGROUND Children with neurodevelopmental disorders have a high risk of sleep disturbances, with insomnia being the most common sleep disorder (i.e., chronic and frequent difficulties with going and staying asleep). Insomnia adversely affects the well-being of these children and their caregivers. Pediatric sleep experts recommend behavioral interventions as the first-line treatment option for children. Better Nights, Better Days for Children with Neurodevelopmental Disorders (BNBD-NDD) is a five-session eHealth behavioural intervention delivered to parents to improve outcomes (e.g., Pediatric Quality of Life Inventory) for their children (4-12 years) with insomnia and who have a diagnosis of mild-to-moderate attention-deficit/hyperactivity disorder, autism spectrum disorder, cerebral palsy, and/or fetal alcohol spectrum disorder. If effective, BNBD-NDD can be a scalable intervention that provides value to an underserved population. OBJECTIVE This protocol outlines an economic evaluation conducted alongside the BNBD-NDD randomized controlled trial (RCT) that aims to assess its costs and effectiveness compared to usual care. METHODS The BNBD-NDD RCT evaluates the impacts of the intervention on children’s sleep and quality of life, as well as parent daytime functioning and psychosocial health. Parent participants were randomized to the BNBD-NDD treatment or to usual care. The economic evaluation assesses outcomes at baseline and 8 months later, which include the Pediatric Quality of Life Inventory (PedsQL) as the primary measure. Quality of life outcomes facilitates the comparison of competing interventions across different populations and medical conditions. Cost items include the BNBD-NDD intervention and parent-reported utilization of private and publicly funded resources for their children’s insomnia. The economic evaluation involves a reference-case cost-effectiveness analysis to examine the incremental cost of BNBD-NDD per unit(s) gain in the PedsQL from the family payer perspective and a cost-consequence analysis from a societal perspective. These analyses will be conducted over an 8-month time horizon. RESULTS The BNBD-NDD RCT data collection commenced in June 2019 and ended in April 2022. The RCT data are currently being analyzed, and data relevant to the economic analysis will be analyzed concurrently. CONCLUSIONS To our knowledge, this will be the first economic evaluation of an eHealth intervention for insomnia in children with neurodevelopmental disorders. This evaluation's findings can inform users and stakeholders regarding the costs and benefits of BNBD-NDD. CLINICALTRIAL ClinicalTrial.gov ID NCT02694003