Abstract
Background: Up to 25% of 1- to 10-year-old children experience insomnia (ie, resisting bedtime, trouble falling asleep, night awakenings, and waking too early in the morning). Insomnia can be associated with excessive daytime sleepiness and negative effects on daytime functioning across multiple domains (eg, behavior, mood, attention, and learning). Despite robust evidence supporting the effectiveness of behavioral treatments for insomnia in children, very few children with insomnia receive these treatments, primarily due to a shortage of available treatment resources. Objective: The Better Nights, Better Days (BNBD) internet-based program provides a readily accessible electronic health (eHealth) intervention to support parents in providing evidence-based care for insomnia in typically developing children. The purpose of the randomized controlled trial (RCT) is to evaluate the effectiveness of BNBD in treating insomnia in children aged between 1 and 10 years. Methods: BNBD is a fully automated program, developed based on evidence-based interventions previously tested by the investigators, as well as on the extant literature on this topic. We describe the 2-arm RCT in which participants (500 primary caregivers of children with insomnia residing in Canada) are assigned to intervention or usual care. Results: The effects of this behavioral sleep eHealth intervention will be assessed at 4 and 8 months postrandomization. Assessment includes both sleep (actigraphy, sleep diary) and daytime functioning of the children and daytime functioning of their parents. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials statement. Conclusions: If the intervention is supported by the results of the RCT, we plan to commercialize this program so that it is sustainable and available at a low cost to all families with internet access.
| Original language | English |
|---|---|
| Article number | e76 |
| Journal | JMIR Research Protocols |
| Volume | 20 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2018 |
Bibliographical note
Funding Information:This study was supported by the Canadian Institutes of Health Research Team Grant FRN-TGS 109221. PVC and SKW are supported by the Kids Brain Health Network, a Canadian Network of Centres of Excellence. CTC holds a Canada Research Chair (Tier 1). GJR was supported by the Children’s Health Foundation. The funders had no role in the design of the study and have no role in the management, analysis, or interpretation of data. The authors would like to thank Sydney Dale-McGrath for her significant role in the preparation of the manuscript. We would also like to thank the following research staff for their contributions to the development of this protocol and paper: Aimee Coulombe, Ana Jemcov, Becky Petrie, Katy Schurman, and Meredith Bessey.
Funding Information:
This study was supported by the Canadian Institutes of Health Research Team Grant FRN-TGS 109221. PVC and SKW are supported by the Kids Brain Health Network, a Canadian Network of Centres of Excellence. CTC holds a Canada Research Chair (Tier 1). GJR was supported by the Children’s Health Foundation. The funders had no role in the design of the study and have no role in the management, analysis, or interpretation of data.
Publisher Copyright:
©Penny V Corkum, Graham J Reid, Wendy A Hall, Roger Godbout, Robyn Stremler, Shelly K Weiss, Reut Gruber, Manisha Witmans Christine T Chambers Esmot Ara Begum Pantelis Andreou Gabrielle Rigney.
ASJC Scopus Subject Areas
- General Medicine