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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

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 dom...

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Autores principales: Corkum, Penny V, Reid, Graham J, Hall, Wendy A, Godbout, Roger, Stremler, Robyn, Weiss, Shelly K, Gruber, Reut, Witmans, Manisha, Chambers, Christine T, Begum, Esmot Ara, Andreou, Pantelis, Rigney, Gabrielle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5891669/
https://www.ncbi.nlm.nih.gov/pubmed/29581089
http://dx.doi.org/10.2196/resprot.8348
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author Corkum, Penny V
Reid, Graham J
Hall, Wendy A
Godbout, Roger
Stremler, Robyn
Weiss, Shelly K
Gruber, Reut
Witmans, Manisha
Chambers, Christine T
Begum, Esmot Ara
Andreou, Pantelis
Rigney, Gabrielle
author_facet Corkum, Penny V
Reid, Graham J
Hall, Wendy A
Godbout, Roger
Stremler, Robyn
Weiss, Shelly K
Gruber, Reut
Witmans, Manisha
Chambers, Christine T
Begum, Esmot Ara
Andreou, Pantelis
Rigney, Gabrielle
author_sort Corkum, Penny V
collection PubMed
description 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)
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spelling pubmed-58916692018-04-16 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 Corkum, Penny V Reid, Graham J Hall, Wendy A Godbout, Roger Stremler, Robyn Weiss, Shelly K Gruber, Reut Witmans, Manisha Chambers, Christine T Begum, Esmot Ara Andreou, Pantelis Rigney, Gabrielle JMIR Res Protoc Protocol 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) JMIR Publications 2018-03-26 /pmc/articles/PMC5891669/ /pubmed/29581089 http://dx.doi.org/10.2196/resprot.8348 Text en ©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. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Corkum, Penny V
Reid, Graham J
Hall, Wendy A
Godbout, Roger
Stremler, Robyn
Weiss, Shelly K
Gruber, Reut
Witmans, Manisha
Chambers, Christine T
Begum, Esmot Ara
Andreou, Pantelis
Rigney, Gabrielle
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5891669/
https://www.ncbi.nlm.nih.gov/pubmed/29581089
http://dx.doi.org/10.2196/resprot.8348
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