Evaluation of an Internet-Based Behavioral Intervention to Improve Psychosocial Health Outcomes in Children With Insomnia (Better Nights, Better Days): Protocol for a Randomized Controlled Trial

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

doi:10.2196/resprot.8348

Evaluation of an Internet-Based Behavioral Intervention to Improve Psychosocial Health Outcomes in Children With Insomnia (Better Nights, Better Days): Protocol for a Randomized Controlled Trial

JMIR Res Protoc. 2018 Mar 26;7(3):e76. doi: 10.2196/resprot.8348.

Authors

Penny V Corkum^{1

2

3}, Graham J Reid^{4

5

6

7}, Wendy A Hall⁸, Roger Godbout⁹, Robyn Stremler¹⁰, Shelly K Weiss¹¹, Reut Gruber^{12

13}, Manisha Witmans¹⁴, Christine T Chambers^{1

15

16}, Esmot Ara Begum¹, Pantelis Andreou¹⁷, Gabrielle Rigney¹

Affiliations

¹ Department of Psychology & Neuroscience, Dalhousie University, Halifax, NS, Canada.
² Department of Psychiatry, Dalhousie University, Halifax, NS, Canada.
³ Department of Pediatrics, IWK Health Centre, Halifax, NS, Canada.
⁴ Department of Psychology, University of Western Ontario, London, ON, Canada.
⁵ Department of Family Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada.
⁶ Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
⁷ Children's Health Research Institute & Lawson Health Research Institute, London, ON, Canada.
⁸ School of Nursing, Faculty of Applied Science, University of British Columbia, Vancouver, BC, Canada.
⁹ Department of Psychiatry, Université de Montréal, Montréal, QC, Canada.
¹⁰ Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada.
¹¹ Division of Neurology, Department of Paediatrics, University of Toronto, Toronto, ON, Canada.
¹² Department of Psychiatry, Faculty of Medicine, McGill University, Montréal, QC, Canada.
¹³ Attention Behavior and Sleep Lab, Douglas Mental Health University Institute, McGill University, Montréal, QC, Canada.
¹⁴ Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.
¹⁵ Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.
¹⁶ Centre for Pediatric Pain Research, IWK Health Centre, Halifax, NS, Canada.
¹⁷ Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.

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.

Trial registration: ClinicalTrials.gov NCT02243501; https://clinicaltrials.gov/show/NCT02243501 (Archived by WebCite at http://www.webcitation.org/6x8Z5pBui).

Keywords: Internet; children; eHealth; insomnia; randomized controlled trial; sleep; treatment.

©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. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.03.2018.

Associated data

ClinicalTrials.gov/NCT02243501