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 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)

1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract.If possible, also mention theories and principles used for designing the site.Keep in mind the needs of systematic reviewers and indexers by including important synonyms.(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i?* Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any).(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The relevant section of the abstract where the level of human involvement is defined is copied below: "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." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment).Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials).Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered.To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e.participants can self-enrol).(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The relevant sections of the abstract where the intervention components are described are copied below: "Objectives: The Better Nights, Better Days® (BNBD) online program provides a readily accessible eHealth intervention to support parents in providing evidence-based care for insomnia in typically developing children aged 1-to 10-years old.Methods: BNBD is a fully automated program, developed based on id b d i t ti i l t t d b th i ti t

INTRODUCTION 2a)
In INTRODUCTION: Scienti c background and explanation of rationale 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program?Intended for a particular patient population?Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions?(Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 2a-ii) Scienti c background, rationale: What is known about the (type of) system Scienti c background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speci c study, from which stakeholder viewpoint is the study performed, potential impact of ndings [2].Brie y justify the choice of the comparator.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-ii?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The relevant sections from the paper outlining the type of problem and solution that is the object of the study is copied below: Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems.A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript details a protocol for a national RCT, changes to the intervention that may be implemented after the trial commencement or events that may impact the study design are not reported in this protocol.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study An inclusion criterion explicitly articulates that participants must "have regular access to high speed internet connection and an email account," ensuring participants have access to, and use of the internet.Literacy is addressed as a requisite criterion that participants must be "comfortable communicating in English or French for day-to-day tasks (e.g., listening to the news on the radio or watching TV, reading books, magazines, etc.)." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant.In online-only trials, clarify if participants were quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 4a-iii) Information giving during recruitment Information given during recruitment.Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This item is not addressed in the protocol manuscript as the institutional affiliations of the investigators were not deemed to bias recruitment or study results.
5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, a liations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The name of the intervention software developer is addressed in the following section of the paper: "eHealth Intervention … The intervention is hosted on the BeHealth Solution, LLC's proprietary technology platform [68] and can be accessed through participants' desktops, laptops, tablets, and smartphones." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 13/38

5-iii) Revisions and updating
Revisions and updating.Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This manuscript outlines a research protocol of an RCT to evaluate the intervention that is currently ongoing.As such, information pertaining to the revisions and updating of the intervention during the trial are not reported.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used.Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This manuscript outlines a research protocol of an RCT to evaluate the intervention that is currently ongoing.The Better Nights, Better Days intervention is protected by a trademark registered under the Canadian Intellectual Property Office, and the intellectual property is governed by an inter-institutional agreement.As such, the source code of the intervention is not provided in this protocol.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org,and/or publishing the source code or screenshots/videos alongside the article).As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group.If known, describe how participants obtained "access to the platform and Internet" [1].To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered".It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc.It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study charts) to help support the implementation of these sleep intervention strategies.
The program can be used at a time that is convenient for the participants, removing barriers to care and providing services in the comfort and privacy of their own homes.The intervention is hosted on the BeHealth Solution, LLC's proprietary technology platform [68] and can be accessed through participants' desktops, laptops, tablets, and smartphones." The following section addresses the level of human involvement in the full-self guided behavioural intervention: 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.).Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text In advance of each subsequent module, participants are asked to record how carefully they reviewed the material, what percentage of the recommended strategies they implemented, and how successful they were in implementing these strategies, , as well as to provide an estimate of the overall percent improvement of their child's sleep problems.Second, computer-generated user statistics captured by the intervention platform software are used to assess adherence, such as the number of times the site was accessed, and the period of time taken to complete each module." 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This manuscript outlines a research protocol of an ongoing RCT.As such, information pertaining to the revisions to the trial outcomes implemented after the trial commenced are not reported.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study satisfaction with services received.The 8 item measure asks parents to rate the services they received through the BNBD intervention on a 4point Likert-scale.Participants can also elaborate and provide any additional feedback on the intervention in text-box format.Internal consistency for the CSQ-8 is reported with alphas ranging from .83 to .93 [126].An overall score for the CQS-8 is produced by summing all item responses producing scores ranging from 8 to 32, with higher values indicating higher satisfaction.The CSQ-8 takes approximately 5 to 7 minutes to complete."power of .80 to detect a significant group by time interaction with the effect size (d) = .45and alpha set to .025, for primary outcome measures calculated from actigraphy and sleep diary from baseline to 4month follow-up.Given that two primary outcome variables are being used (sleep efficiency from actigraphy and sleep efficiency from sleep diaries), alpha was divided by two so that P = .025,rather than P = .05would be accepted as indication of statistical significance.This is based on the assumption that an effect size of d =. 45  Does your paper address subitem 11a-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants randomized to the Intervention Group receive access to the intervention, while the Usual Care group, as the control comparator, do not receive access to the intervention until the post 8-month assessment period.Participants are therefore aware if they have been assigned to the intervention versus the comparator condition.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study b) Secondary Outcome: For the secondary outcomes, we will test differences between the two groups modeling changes in the outcome variables across the three points of measurement (baseline, 4-and 8months post randomization) to determine treatment effects at 8-months post-randomization.Again, a significant Time-X-Group interaction would indicate differential rate of change over time between groups.Differences in the estimated means at the 4-month and 8-month posttreatment time points will also be examined." The relevant section outlining the planned imputation techniques to deal with missing values is outlined below: Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The manuscript comments on ethical approval for the protocol within the Ethical Considerations section of the manuscript, stating: "Ethics approval was granted by IWK Health Center Research Ethics Board."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how?Checkbox, etc.?), and what information was provided (see 4a-ii).See [6] for some items to be included in informed consent documents.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study X26-iii) Safety and security procedures Safety and security procedures, incl.privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The manuscript reports on a research protocol of a national RCT that is currently ongoing.As such, results related to the participants' randomization assignment and data analysis are not reported.
participate at any time, and they are informed of the aims, methods, benefits and risks of the study.All participants are given an opportunity to contact research staff by email or to request a phone call to have any questions answered and concerns addressed.A series of true and false questions to test a participant's knowledge of their research rights are used to ensure informed consent.A copy of both the Screening Information and Consent Form and the Information and Consent Form are available to be downloaded and saved by participants.Participants provide an electronic signature and date and click an "I Agree" button." be dealt with adequately by research staff are immediately communicated to the Principal Investigator or her delegate (Co-Investigator) and follow-up with the participant is made to ensure their well-being.Data monitoring for adverse events or trends in outcome has not been undertaken given that this is a low risk study.An Adverse Events Committee, composed of the three members from Dalhousie University, not associated with the BNBD study, and having medical, psychology, and sleep expertise, will review adverse events if one becomes known during the course of the study." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study A CONSORT schematic flow diagram is included as Figure 1 in this mansucript.However as this manuscript reports on the study protocol of an ongoing RCT, no results regarding losses and exclusions postrandomization are reported.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study A CONSORT schematic flow diagram is included as Figure 1 in this manuscript.However as this manuscript reports on the study protocol of an ongoing RCT, no results regarding losses and exclusions postrandomization are reported.
14a) Dates de ning the periods of recruitment and followup Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding the periods of recruitment and follow-up are reported.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding secular events of the study period are discussed.
14b) Why the trial ended or was stopped (early) As this manuscript reports on the study protocol of an ongoing RCT, no results regarding participant numbers included in analysis are reported.
16-ii) Primary analysis should be intent-to-treat Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding participant numbers are reported.The protocol manuscript specifies that "Data analyses are overseen by the research team, including the statistician, using an intent-to-treat data analytic approach [100]." 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding data analysis are reported.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical.This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length".These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding data analysis are reported.
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding data analysis are reported.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, data analysis and interpretation are not reported.
22-ii) Highlight unanswered new questions, suggest future research Highlight unanswered new questions, suggest future research.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, data analysis and interpretation are not reported.

20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded.Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error.Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 34/38 As this manuscript reports on the study protocol of an ongoing RCT, data analysis and interpretation are not reported.
21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, data analysis and interpretation are not reported.
21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study was supported by the Canadian Institutes of Health Research (CIHR) Team Grant FRN-TGS 109221.This information is included in the Acknowledgements section of the manuscript.
X27) Con icts of Interest (not a CONSORT item) X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There are no conflicts of interest to declare.This information is included in the section titled Conflicts of Interest.

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript?* yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?
Additional pertinent information was included in the manuscript regarding the administration of the online questionnaires according to the CHERRIES recommendations.

4-
Month and 8-Month Follow-up Primary outcome measures (sleep diary and actigraphy), secondary outcome measures (questionnaires) and measures to address exploratory questions are administered to all participants at baseline and at 4-and 8-months post-randomization.Participants receive an automated invitation email from REDCap to start their 4-month follow-up after 16-weeks post-randomization, and to start their 8-month follow-up 32-weeks post-randomization."https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 18/38If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9 intervention platform in the spring of 2016.Internal reviewers, including program developers with BeHealth Solutions, LLC, and research staff at Corkum LABS reviewed the intervention to identify technical problems.Six parents of children ages 1-to 10-years old also served as external reviewers for the program and completed five questionnaires to provide structured feedback on the technical operation of each session of the intervention.The goal of this step was to identify functional problems with the program (e.g., broken links, incorrect routing) prior to conducting the RCT." the intervention platform in the spring of 2016.Internal reviewers, including program developers with BeHealth Solutions, LLC, and research staff at Corkum LABS reviewed the intervention to identify technical problems.Six external reviewers, parents of children ages 1- to 10-years old, also reviewed the program and completed five questionnaires to provide structured feedback on the technical operation of each session of the intervention.The goal of this step was to identify functional problems with the program (e.g., broken links, incorrect routing) prior to conducting the RCT." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 14/38 Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, ). 1 2 3 4 5 subitem not at all important essential https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 15/38 Does your paper address subitem 5-vii?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 5-viii) persuasive features, etc., see e.g., [7, 8] for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback" [6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous [6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. [1].* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 5-ix) Describe use parameters subitem not at all important essential Does your paper address subitem 5-ix?Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 16/38 The intervention includes five sessions made available sequentially to participants.Table2summarizes the content of the intervention.The recommended completion time of the intervention ranges from 5-10 weeks.Participants receive an automated email reminder when a session becomes available, a prompt to complete each session, and seven notices that the recommended completion time is approaching."5-xii) Describe any co-interventions (incl.training/support) Describe any co-interventions (incl.training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention.This includes training sessions and support [1].It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. *Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your studyThe intervention is designed to be fully self-guided, empowering parents of children with insomnia to implement behavioural strategies independently.Therefore no additional co-interventions, training or support for users (i.e., contact with coaches or clinicians).
…All measures are available in both English and French, based on whether the participant has enrolled in the English or French language trial.All secondary and exploratory outcome measures are administered online via REDCap.All electronic questionnaires underwent technical and usability testing by research staff and external reviewers, as well as by six parents of children ages 1-10 years.All questionnaires are displayed in a sequential manner.Certain measures are age-dependent and REDCap automatically delivers them accordingly." Research staff members randomize participants using an automated REDCap procedure.The randomization table, created in Excel, is uploaded into the REDCap database, where it cannot be modified or accessed.Only the research associate is able to view the randomization table.Once a participant completes baseline assessment, research staff members confirm all criteria are met and "trigger" the automated randomization by clicking a button within the program.An automated email is sent to participants to notify them of the randomization result."Whenapplicable,details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials.Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic[4]).
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 23/38 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: Does your paper address CONSORT subitem 12b? * outcomes (sleep diary and actigraphy).Analysis is based on the methodology of the extension of the GLM for longitudinal data, namely marginal and random effects modeling which allows for varying intercepts and slopes across subjects, 'G-side' random effects, and different within person error variance covariance structure, 'R-side' random effects[103, 104].An interaction of age group (Toddler, Preschool, School-Aged) x time (3 assessments) x randomization group (Intervention, Usual Care) would indicate differential response to treatment." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 25/38 Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding the periods of recruitment and follow-up are reported.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding the baseline demographic and clinical characteristics of each group are available and are therefore not reported.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no results regarding participant demographics are reported.
NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 15? * Does your paper address subitem 16-i?*Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 29/38 Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As this manuscript reports on the study protocol of an ongoing RCT, no harms or unintended effects are reported.In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 19-i?Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 32/38As this manuscript reports on the study protocol of an ongoing RCT, no harms or unintended effects are reported.NPT:subitem not at all important essential Does your paper address subitem 22-i?* https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 33/38