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An eHealth Program for Insomnia in Children With Neurodevelopmental Disorders (Better Nights, Better Days): Protocol
Xiao Yang Jia1, Pantelis Andreou2, Cary Brown3
1The School of Public Policy, University of Calgary, Calgary, AB, Canada.
Insights
This study evaluates the cost-effectiveness of the Better Nights, Better Days for Children with Neurodevelopmental Disorders (BNBD-NDD) eHealth intervention for improving sleep in children with neurodevelopmental disorders.
Area of Science:
- Pediatric Sleep Medicine
- Health Economics
- Digital Health Interventions
Background:
- Children with neurodevelopmental disorders frequently experience insomnia, impacting their well-being and that of their caregivers.
- Behavioral interventions are recommended as a first-line treatment for pediatric insomnia.
- The Better Nights, Better Days for Children with Neurodevelopmental Disorders (BNBD-NDD) is a parent-delivered eHealth intervention targeting insomnia in children (ages 4-12) with specific neurodevelopmental conditions.
Purpose of the Study:
- To conduct an economic evaluation alongside a randomized controlled trial (RCT) of the BNBD-NDD intervention.
- To assess the costs, efficacy, and cost-effectiveness of BNBD-NDD compared to usual care.
- To determine the value of BNBD-NDD for an underserved population.
Main Methods:
- The BNBD-NDD RCT randomized parents to either the intervention or usual care, assessing impacts on child sleep, quality of life (Pediatric Quality of Life Inventory [PedsQL]), and parent functioning.
- An economic evaluation was performed, collecting data at baseline and 8 months.
- Cost-effectiveness and cost-consequence analyses were conducted from family payer and societal perspectives, respectively, over an 8-month horizon.
Main Results:
- Funding was secured, and ethical approvals were obtained in 2015 and 2019/2022.
- Data collection for the RCT occurred between June 2019 and April 2022.
- Data analysis for the RCT and concurrent economic evaluation is ongoing.
Conclusions:
- This represents the first economic evaluation of an eHealth intervention for insomnia in children with neurodevelopmental disorders.
- Findings will inform stakeholders about the costs and benefits of the BNBD-NDD intervention.
- The study protocol outlines a rigorous approach to evaluating a scalable digital health solution.
Background:
Children with neurodevelopmental disorders have a high risk of sleep disturbances, with insomnia being the most common sleep disorder (ie, 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 5-session eHealth behavioral intervention delivered to parents to improve outcomes (eg, Pediatric Quality of Life Inventory [PedsQL]) for their children (ages 4-12 years) with insomnia and who have a diagnosis of mild to moderate attention-deficit/hyperactivity disorder, autism spectrum disorder, cerebral palsy, or fetal alcohol spectrum disorder. If cost-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, efficacy, and cost-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 parents' 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 PedsQL as the primary measure. Quality of life outcomes facilitate the comparison of competing interventions across different populations and medical conditions. Cost items include the BNBD-NDD intervention and parent-reported usage 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 units gained 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:
Research funding was obtained from the Kids Brain Health Network in 2015. Ethics were approved by the IWK Health Research Ethics Board and the University of Calgary Conjoint Health Research Ethics Board in January 2019 and June 2022, respectively. 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.
Trial Registration:
ClinicalTrial.gov NCT02694003; https://clinicaltrials.gov/study/NCT02694003.
International Registered Report Identifier (Irrid):
DERR1-10.2196/46735.
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