Effectiveness of a Technology-Based Injury Prevention Program for Enhancing Mothers’ Knowledge of Child Safety: Protocol for a Randomized Controlled Trial

Background Provision of anticipatory guidance for parents is recommended as an effective strategy to prevent injuries among young children. Technology-based anticipatory guidance has been suggested to reinforce the effectiveness of injury prevention and improve parents’ knowledge of child safety. Objective This study aims to examine the effectiveness of a technology-based injury prevention program with parental anticipatory guidance for enhancing mothers’ knowledge of child safety. Methods In this randomized controlled trial, 308 mothers will be recruited from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomly assigned into intervention and control groups. Mothers in the intervention group will be given free access to a technology-based injury prevention program with anticipatory guidance, whereas mothers in the control group will be given a relevant booklet on parenting. The injury prevention program, available as a website or on a mobile app, includes behavioral components based on the Theory of Planned Behavior. The primary outcome measure will be the change in the mother’s knowledge of child safety. The secondary outcome measures will be age-appropriate domestic safety knowledge, attitudes, intentions, perceived behavioral control, and self-reported behavior related to home safety practice. We will also determine dose-response relationships between the outcome measures and the website and mobile app usage. Results Enrolment of participants will begin in October 2016. Results are expected by June 2018. Conclusions Parents will be able to easily access the domestic injury prevention website to find information regarding child injury prevention. It is anticipated that the technology-based intervention will help parents improve their knowledge of child safety and raise their awareness about the consequences of domestic injuries and the importance of prevention. Trial Registration Clinicaltrials.gov Clinicaltrials.gov NCT02835768; http://clinicaltrials.gov/ct2/show/NCT02835768 (Archived by WebCite at http://www.webcitation/6lbXYM6b9)

I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Other: 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if ofᴀine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-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 brieᴀy explain why the item is not applicable/relevant for your study Mothers in intervention group will be provided with free access to a technologybased injury prevention program with anticipatory guideline whereas those in the control group will receive relevant parenting booklet.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-ii?
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 brieᴀy explain why the item is not applicable/relevant for your study Mothers in intervention group will be provided with free access to a technologybased injury prevention program with anticipatory guideline whereas those in the control group will receive relevant parenting booklet.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-iii? * 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 brieᴀy explain why the item is not applicable/relevant for your study The study would adopt a randomized controlled trial design and recruit 308 mothers from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong.
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 brieᴀy explain why the item is not applicable/relevant for your study The intervention will base on the Injury Prevention Program and the Theory of Planned Behavior.
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) 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 brieᴀy explain why the item is not applicable/relevant for your study 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. ofᴀ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 ofᴀ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 brieᴀy explain why the item is not applicable/relevant for your study The study would adopt a randomized controlled trial design and recruit 308 mothers from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong.
1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (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-iv?
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 brieᴀy explain why the item is not applicable/relevant for your study 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 brieᴀy explain why the item is not applicable/relevant for your study The systematic review identified only two mobile interventions out of 44 technologybased interventions [19]. It is suggested that more mobile interventions for injury prevention should be developed and evaluated in the future.
Therefore, we propose a new technologybased program including both web and mobileappbased intervention in this study with parental anticipatory guidance on child injury prevention, and also examine its effectiveness in enhancing mothers' knowledge on child safety.

2b) In INTRODUCTION: Speci c objectives or hypotheses
Does your paper address CONSORT subitem 2b? * 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 brieᴀy explain why the item is not applicable/relevant for your study We aim at increasing mothers' knowledge and motivation of learning about pediatric unintentional domestic injury prevention through a new technologybased model, and also target to improve mothers' attitudes and their perceived behavioral control of domestic safety practice. Website usage will be evaluated in terms of its reach and engagement statistics. User acceptance evaluation will be also conducted at the end of the intervention period to collect feedback from users about website interface.

METHODS
3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * 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 brieᴀy explain why the item is not applicable/relevant for your study The allocation ratio is 1:1, comparing the technologybased intervention versus an information package.
3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * 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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol 3b-i) Bug ˸xes, Downtimes, Content Changes 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 inᴀuenced study design such as staff changes, system failures/downtimes, etc.
[2]. Not applicable for a research 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 brieᴀy explain why the item is not applicable/relevant for your study The inclusion criterion includes mothers attending the antenatal clinics/staying in the postnatal wards at Kwong Wah Hospital or Queen Mary Hospital. The exclusion criteria include subjects unable to read Chinese and those without access to Internet.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. 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 brieᴀy explain why the item is not applicable/relevant for your study During the recruitment period, nurses will identify potential participants and an experienced research assistant will help to obtain consent by explaining and providing participants with study information sheet and a consent form to complete.
Periodical phone reminders and electronic leaflets will be delivered to participants in the intervention group, in order to encourage and engage them to access the domestic safety website. Therefore, participants in the intervention group will be provided with technologybased injury prevention materials in addition to the parenting booklet from MCHCs, but those in the control group will only receive the parenting booklet.
The research team provided technical support to participants who encountered any technical problems accessing to the intervention website and mobile app. Apart from that, no other therapist/nurse/care provider/physicianassisted intervention was provided in addition to the intervention website and mobile app.
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 brieᴀy explain why the item is not applicable/relevant for your study During the recruitment period, nurses will identify potential participants and an experienced research assistant will help to obtain consent by explaining and providing participants with study information sheet and a consent form to complete.
4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * 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 brieᴀy explain why the item is not applicable/relevant for your study The existing CIPRA website will be revamped to facilitate the intervention design for this study and will be cohosted by CIPRA and the authors' department. A mobile app will be developed which could be downloaded and used with Android phone and iPhone. The server, which would be placed and managed under the authors' department, is a Linux Server with a regular backup system to prevent any accidental data loss.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-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 brieᴀy explain why the item is not applicable/relevant for your study Those who consented for participation will be asked to complete a general safety questionnaire either at the antenatal clinic or postnatal ward of the two hospitals. Ageappropriate safety knowledge, attitude, intention, perceived behavioral control, and selfreported behaviors of domestic safety practice will be assessed at each specified developmental age when the child reaches 2, 6, 9, 12 and 18month old. After completion of ageappropriate questionnaire, intervened participants will be counselled with immediate feedbacks on specific injury prevention behavior prompted by the "atrisk" (incorrect) answers obtained from the questionnaire. This online feedback counselling approach is aimed to educate mothers and to enhance their awareness about prevention of domestic injury. At the end of the counselling, each intervened participant will be provided with ageappropriate safety messages. Participants' general safety knowledge will be reassessed when their children reach 18monthold. Participants will be contacted and reminded by phone call and email to complete the ageappropriate safety questionnaires, and the general safety questionnaire. For control group, mothers will be contacted at the same schedule as the intervention group; they will be reminded to complete the questionnaires and to read the booklets.

4b-ii) Report how institutional af˸liations are displayed
Report how institutional af liations are displayed to potential participants [on ehealth media], as af liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential 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 brieᴀy explain why the item is not applicable/relevant for your study 5) The interventions for each group with suf cient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, af˸liations of the developers, sponsors, and owners Mention names, credential, af 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 "Conᴀ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 brieᴀy explain why the item is not applicable/relevant for your study The existing CIPRA website will be revamped to facilitate the intervention design for this study and will be cohosted by CIPRA and the authors' department. A mobile app will be developed which could be downloaded and used with Android phone and iPhone.

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 brieᴀy explain why the item is not applicable/relevant for your study

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 brieᴀy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2… 13/36

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 brieᴀ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 翿owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing ᴀ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 brieᴀy explain why the item is not applicable/relevant for your study

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 brieᴀ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).
1 2 3 4 5 subitem not at all important essential 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 brieᴀy explain why the item is not applicable/relevant for your study The allocation ratio is 1:1, comparing the technologybased intervention versus an information package. Each participant will be provided an information package -the parenting booklet from Maternal and Child Health Centres (MCHCs). This booklet is publicly available for mothers about domestic safety tips which are brief and general for children under 3 yearold. For the intervention group, participants will be given an additional leaflet about the domestic safety website with address link and brief introductory information. subitem not at all important essential Does your paper address subitem 5-viii? * 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 brieᴀy explain why the item is not applicable/relevant for your study

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
In the intervention website, the Injury Prevention Program (TIPP) introduced by American Academy of Pediatrics will be used as the core strategy of our domestic injury prevention intervention [23]. A review of the literature on childhood injury prevention demonstrated that TIPP is effective in improving knowledge and better domestic safety practices [24]. The intervention will consist of the general domestic safety tips in the CIPRA website and the TIPP program to provide anticipatory guidance. As a result, enriched domestic injury prevention information "Home Safety Tips" will be provided and divided into five stages according to various safety issues relevant to infants/young children's age groups (Table 1).
The value of using a behavioral approach to design injury prevention program has been widely recognized by researchers [24,25]. The Theory of Planned Behavior is a model that links beliefs and behavior [26]. It predicts people's intention to perform actual behaviors and intention comprise of three important elements: attitude, subjective norms and perceived behavioral control. Attitude derives from a person's perception about consequences of behavior and the importance of these consequences to the individual. Social norms derives from one's perception of beliefs about significant others' preference and the individual's motivation to comply with their wishes. Perceived behavioral control derives from a person's perception of the difficulty to conduct the behavior. Adrianensens et al. reported that online intervention is able to deliver a positive effect on knowledge, attitude, intention and actual injury preventive behavior [27]. Therefore, apart from a knowledge hub, the intervention website and mobile app will incorporate additional functions of feedback counselling, online consultation, discussion forum, interactive games and video demonstration to further improve participants' attitude, intention and perceived behavioral control to adopt safety practice.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
1 2 3 4 5 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 not in the ms, or brieᴀy explain why the item is not applicable/relevant for your study Doseresponse relationship between the outcome measures, and website and mobile app usage will be determined by correlation analysis.

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 brieᴀy explain why the item is not applicable/relevant for your study The research team provided technical support to participants who encountered any technical problems accessing to the intervention website and mobile app. Apart from that, no other therapist/nurse/care provider/physicianassisted intervention was provided in addition to the intervention website and mobile app.

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 brieᴀy explain why the item is not applicable/relevant for your study Periodical phone reminders and electronic leaflets will be delivered to participants in the intervention group, in order to encourage and engage them to access the domestic safety website.

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * 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 brieᴀy explain why the item is not applicable/relevant for your study Each participant will be provided an information package -the parenting booklet from Maternal and Child Health Centres (MCHCs). 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 brieᴀy explain why the item is not applicable/relevant for your study This study aims to increase mothers' knowledge about child domestic safety and to improve their attitudes, intentions, perceived behavioral control, and actual behaviors of domestic safety practice. The following components of evaluation will be included to demonstrate the effectiveness of the technologybased intervention.
Those who consented for participation will be asked to complete a general safety questionnaire either at the antenatal clinic or postnatal ward of the two hospitals. Ageappropriate safety knowledge, attitude, intention, perceived behavioral control, and selfreported behaviors of domestic safety practice will be assessed at each specified developmental age when the child reaches 2, 6, 9, 12 and 18month old. After completion of ageappropriate questionnaire, intervened participants will be counselled with immediate feedbacks on specific injury prevention behavior prompted by the "atrisk" (incorrect) answers obtained from the questionnaire. This online feedback counselling approach is aimed to educate mothers and to enhance their awareness about prevention of domestic injury. At the end of the counselling, each intervened participant will be provided with ageappropriate safety messages. Participants' general safety knowledge will be reassessed when their children reach 18monthold. Participants will be contacted and reminded by phone call and email to complete the ageappropriate safety questionnaires, and the general safety questionnaire. For control group, mothers will be contacted at the same schedule as the intervention group; they will be reminded to complete the questionnaires and to read the booklets.
6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If 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].
1 2 3 4 5 subitem not at all important essential 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. Not applicable for a research protocol 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 brieᴀy explain why the item is not applicable/relevant for your study Referenced to a computerbased parenting intervention for child injury prevention [21] that reported a small to medium effect (d=0.42) in terms of the knowledge change, 92 subjects for this intervention will be needed to detect the effect at 5% significant level and 80% statistical power. Assuming 40% of attrition between pre and postevaluation, at least 154 participants should be recruited in each of the intervention and control groups.

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * 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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * 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 brieᴀy explain why the item is not applicable/relevant for your study The participants will be assigned randomly to the intervention group or the control group by stratified randomizations within hospitals using computer generated random numbers with R Statistical Software. The participants will receive sealed opaque envelopes with the access information to the intervention website or the control. The participant recruitment and randomization process will be carried out by different research assistants independently. Outcome assessors will be masked to the group allocation for participants.
8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * 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 brieᴀy explain why the item is not applicable/relevant for your study The participants will be assigned randomly to the intervention group or the control group by stratified randomizations within hospitals using computer generated random numbers with R Statistical Software. The participants will receive sealed opaque envelopes with the access information to the intervention website or the control. The participant recruitment and randomization process will be carried out by different research assistants independently. Outcome assessors will be masked to the group allocation for participants. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * 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 brieᴀy explain why the item is not applicable/relevant for your study The participants will be assigned randomly to the intervention group or the control group by stratified randomizations within hospitals using computer generated random numbers with R Statistical Software. The participants will receive sealed opaque envelopes with the access information to the intervention website or the control. The participant recruitment and randomization process will be carried out by different research assistants independently. Outcome assessors will be masked to the group allocation for participants.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 brieᴀy explain why the item is not applicable/relevant for your study The participants will be assigned randomly to the intervention group or the control group by stratified randomizations within hospitals using computer generated random numbers with R Statistical Software. The participants will receive sealed opaque envelopes with the access information to the intervention website or the control. The participant recruitment and randomization process will be carried out by different research assistants independently. Outcome assessors will be masked to the group allocation for participants.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

2 3 4 5
subitem not at all important essential 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 brieᴀy explain why the item is not applicable/relevant for your study The participants will be assigned randomly to the intervention group or the control group by stratified randomizations within hospitals using computer generated random numbers with R Statistical Software. The participants will receive sealed opaque envelopes with the access information to the intervention website or the control. The participant recruitment and randomization process will be carried out by different research assistants independently. Outcome assessors will be masked to the group allocation for participants.
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 brieᴀy explain why the item is not applicable/relevant for your study 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * 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 brieᴀy explain why the item is not applicable/relevant for your study 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, 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 brieᴀy explain why the item is not applicable/relevant for your study The change in maternal knowledge on child safety will be studied by comparing their knowledge before joining and after finishing the injury prevention program and also by comparing the child injury prevention knowledge of subjects in the intervention and control groups. Regression analysis will be used to examine the intervention effectiveness adjusted for participant demographics (e.g. gender, age, socioeconomic status of the parent). Data will be analyzed through an intenttotreat analysis to address loss of followup data. Independent samples ttest will be used to examine the betweengroup differences in ageappropriate safety knowledge, attitude, intention, perceived behavioral control, and actual behaviors of safety practice. Doseresponse relationship between the outcome measures, and website and mobile app usage will be determined by correlation analysis. Website and app usage data will be summarized based on number of registrants and their time spent during the entire intervention period. Summary of user acceptance evaluation will be complied for further improvement and development of the website and the app.
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]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-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 brieᴀy explain why the item is not applicable/relevant for your study Data will be analyzed through an intenttotreat analysis to address loss of followup data.

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * 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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item) X26-i) Comment on ethics committee approval 1 2 3 4 5 subitem not at all important essential 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 brieᴀy explain why the item is not applicable/relevant for your study This study is registered with Clinicaltrials.gov (Identifier: NCT02835768). This study has been approved by the Institutional Review Board of Hong Kong University and Hospital Authority Hong Kong West Cluster (Reference number: UW 15465). All participants will give their informed written consent.

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ofᴀ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 brieᴀy explain why the item is not applicable/relevant for your study During the recruitment period, nurses will identify potential participants and an experienced research assistant will help to obtain consent by explaining and providing participants with study information sheet and a consent form to complete.

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 brieᴀy explain why the item is not applicable/relevant for your study However, in case of emergency, participants are instructed to contact and attend the nearest accident and emergency department.

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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol 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 翿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 brieᴀy explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 14b? * 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 brieᴀy explain why the item is not applicable/relevant for your study subitem not at all important essential Does your paper address subitem 15-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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide de˸nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential 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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol

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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol 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 brieᴀy explain why the item is not applicable/relevant for your study 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).
indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieᴀy explain why the item is not applicable/relevant for your study Not applicable for a research protocol

18-i) Subgroup analysis of comparing only users
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). subitem not at all important essential Does your paper address subitem 22-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 brieᴀy explain why the item is not applicable/relevant for your study This study will offer a technologybased intervention for raising mothers' awareness of the severity and consequences caused by domestic injuries. Participating mothers can receive a combination of ageappropriate information about child health, parenting and safety. Mothers who concern about childhood safety relevant to specific developmental stage would have the opportunity to enhance their knowledge about available resources and services, and their providers, along with relevant linkages, so that support to mothers, children as well as the community is optimally coordinated.

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 brieᴀy explain why the item is not applicable/relevant for your study When disseminating the intervention within the community, we will further compare the intervention with other services by collecting feedback from different users, interviewing relevant stakeholders, and conducting ecological and econometric studies to access the longterm social impact and further improve the intervention to meet community needs. 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 brieᴀy explain why the item is not applicable/relevant for your study Not applicable for research protocol 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 brieᴀy explain why the item is not applicable/relevant for your study 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 brieᴀy explain why the item is not applicable/relevant for your study OTHER INFORMATION 23) Registration number and name of trial registry Does your paper address CONSORT subitem 23? * 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 brieᴀy explain why the item is not applicable/relevant for your study This study is registered with Clinicaltrials.gov (Identifier: NCT02835768).

24) Where the full trial protocol can be accessed, if available
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or 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 brieᴀy explain why the item is not applicable/relevant for your study This study is registered with Clinicaltrials.gov (Identifier: NCT02835768).

25)
Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * 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 brieᴀy explain why the item is not applicable/relevant for your study The proposed project was successfully funded by the Health Care and Promotion Fund (Project No.: 08150345) of the Food and Health Bureau, Hong Kong government in March 2016 after a stringent external review process. Enrolment of participants would be started in Oct 2016, and the results are expected to be ready by June 2018.

X27) Conᴀ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 brieᴀy explain why the item is not applicable/relevant for your study 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?
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * 1 hour