The Effects of a Web-Based Tool for Parents of Children With Juvenile Idiopathic Arthritis: Randomized Controlled Trial

Background Juvenile idiopathic arthritis (JIA) is a group of autoinflammatory diseases that cause pain and disability if not controlled by treatment. Parenting a child with JIA is stressful for parents, who express concerns about their child’s treatment and may experience anxiety and powerlessness concerning their child’s illness. Parenting stress is greater in parents of children with chronic illness than in those with healthy children and is related to poorer psychological adjustment in both parents and children. It is therefore important to develop interventions to support parents. This paper reports the evaluation of a web-based tool that provides information and practical skills to help increase parents’ confidence in managing their child’s illness and reduce parenting stress. Objective The aim of this study is to evaluate the benefits of a web-based tool (WebParC) for parents of children with recently diagnosed JIA. Methods A multicentered randomized controlled trial was conducted at pediatric rheumatology centers in England. We recruited parents of children aged ≤12 years who had been diagnosed with JIA within the previous 6 months. They were randomized to the intervention (WebParC access plus standard care) or the control (standard care alone) and followed up 4 months and 12 months after randomization. Where both parents participated, they were randomized by household to the same trial arm. The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive behavioral therapy, to help parents develop skills to manage JIA-related issues. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress. The secondary outcomes were parental mood, self-efficacy, coping, effectiveness of participation in their child’s health care, satisfaction with health care, and child’s health-related quality of life. Results A total of 203 households comprising 220 parents were randomized to the intervention (100/203, 49.3%) or control (103/203, 50.7%) arm. Follow-up assessments were completed by 65.5% (133/203) of the households at 4 months (intervention 60/100, 60%, and control 73/103, 70.9%) and 61.1% (124/203) of the households at 12 months (intervention 58/100, 58%, and control 66/103, 64.1%). A main effect of the trial arm was found on the Pediatric Inventory for Parents: the intervention participants reported less frequency (subscales communication F1,120627=5.37; P=.02, and role function F1,27203=5.40; P=.02) and difficulty (subscales communication F1,2237=7.43; P=.006, medical care F1,2907=4.04; P=.04, and role function F1,821=4.37, P=.04) regarding illness-related stressful events than the control participants. Conclusions The WebParC website for parents of children with JIA reduced illness-related parenting stress. This web-based intervention offers a feasible preventive approach for parents of children with JIA and potentially could be adapted and evaluated for parents of children with other chronic illnesses. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 13159730; http://www.isrctn.com/ISRCTN13159730

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * analysis to be reported in separate manuscript Overall, was the app/intervention effective? * 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 offline 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.
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 briefly explain why the item is not applicable/relevant for your study "The Effects of a Web-based Tool for Parents of Children with Juvenile Idiopathic Arthritis: Randomised Controlled Trial."

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").

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 briefly explain why the item is not applicable/relevant for your study not applicable -the intervention is fully web-based subitem not at all important 1 2 3 4 5 essential 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 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 briefly explain why the item is not applicable/relevant for your study "The Effects of a Web-based Tool for Parents of Children with Juvenile Idiopathic Arthritis: Randomised Controlled Trial."

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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 10/55 subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study "The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive-behavioural therapy, to help parents develop skills to manage JIArelated issues." 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) 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 briefly explain why the item is not applicable/relevant for your study "Objective: To evaluate the benefits of a web-based tool ("WebParC") for parents of children with recently diagnosed juvenile idiopathic arthritis (JIA)....They were randomised to the Intervention (WebParC access plus standard care) or the Control (standard care alone)...The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive-behavioural therapy, to help parents develop skills to manage JIA-related issues." 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 briefly explain why the item is not applicable/relevant for your study "Parents ... were recruited when they attended clinic with their child"; "The primary outcome was the self-report Pediatric Inventory for Parents" 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)

INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale
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 briefly explain why the item is not applicable/relevant for your study "A total of 203 'households' were randomised to the Intervention (n=100) or Control (n=103) arm. Follow-up assessments were completed by 133 (65.5%) at 4-months (60 Intervention, 73 Control) and 124 (61.1%) (58 Intervention, 66 Controls) at 12-months." Adherence use is not reported -this manuscript reports the trial outcomes; another process evaluation manuscript is being prepared which will include a detailed analysis of the usage data 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (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) Does your paper address subitem 1b-v?
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 briefly explain why the item is not applicable/relevant for your study "The WebParC website for parents of children with JIA reduced illness-related parenting stress." 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 briefly explain why the item is not applicable/relevant for your study This is covered in the manuscript introduction section.

METHODS
3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 briefly explain why the item is not applicable/relevant for your study "Aim To test that hypothesis that families provided with WebParC in addition to standard care would experience less illness-related parenting stress than those provided standard care alone. " 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 briefly explain why the item is not applicable/relevant for your study "Design Multi-centre RCT." "Randomisation was in a ratio of 1:1 to trial arms. Where both parents participated, they were randomised to the same trial arm (i.e. randomisation clustered by household)." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 briefly explain why the item is not applicable/relevant for your study "If the questionnaire was not returned, a member of the site research team called participants. This was a change to the protocol made part-way through the trial to enhance questionnaire return rates." "Participants were sent a £5 gift voucher on return of each completed study questionnaire A protocol change was made part-way through the trial to enhance questionnaire return rates but was paid retrospectively to all participants."

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
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 briefly explain why the item is not applicable/relevant for your study no changes were made to the intervention or comparator during the trial

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
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 briefly explain why the item is not applicable/relevant for your study Parents were excluded if they had problems with literacy 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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased 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 quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
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 briefly explain why the item is not applicable/relevant for your study "Parents were invited to participate by their child's rheumatologist when attending a clinic appointment with their child." "Intervention arm: In addition to standard care, those allocated to the intervention arm were given free unlimited password-protected access to the website."

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.
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 briefly explain why the item is not applicable/relevant for your study "Parents were invited to participate by their child's rheumatologist when attending a clinic appointment with their child. Interested parents had time to consider participation and opportunities to ask questions before providing written consent to site research staff. If their child with JIA was aged 8-12 years, the child's assent was obtained for their demographic and clinical data to be collected for the research." 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 briefly explain why the item is not applicable/relevant for your study "Parents were invited to participate by their child's rheumatologist when attending a clinic appointment with their child. Interested parents had time to consider participation and opportunities to ask questions before providing written consent to site research staff. If their child with JIA was aged 8-12 years, the child's assent was obtained for their demographic and clinical data to be collected for the research. After providing consent, participants were given baseline questionnaires to complete in clinic or at home and return to the trial co-ordinating centre (freepost envelope provided). A link to an online version of the questionnaire was also provided so parents could choose their preferred completion mode." "At 4 and 12-months post-randomisation, the trial centre sent follow-up questionnaires both electronically and in hardcopy for participants to choose preferred completion method.
Telephone and text reminders were sent if questionnaires were not returned within 2 weeks. Follow-up clinical data for the child (core outcome variables, medication and comorbidities) were obtained from trial sites' clinic notes closest to the follow-up timepoints." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
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 briefly explain why the item is not applicable/relevant for your study "After providing consent, participants were given baseline questionnaires to complete in clinic or at home and return to the trial co-ordinating centre (freepost envelope provided). A link to an online version of the questionnaire was also provided so parents could choose their preferred completion mode." "At 4 and 12-months post-randomisation, the trial centre sent follow-up questionnaires both electronically and in hardcopy for participants to choose preferred completion method.
Telephone and text reminders were sent if questionnaires were not returned within 2 weeks. Follow-up clinical data for the child (core outcome variables, medication and comorbidities) were obtained from trial sites' clinic notes closest to the follow-up timepoints."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations 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) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study not applicable -participants were recruited from their child's hospital

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
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 briefly explain why the item is not applicable/relevant for your study "Trial arms: Control arm: Children of control arm participants continued to receive standard clinical care as provided by the study site.
Intervention arm: In addition to standard care, those allocated to the intervention arm were given free unlimited password-protected access to the website.
Website content was written by health professionals supported by a research assistant. The health professionals included: 13 rheumatologists, four rheumatology nurse specialists, two clinical psychologists, an occupational therapist, an ophthalmologist, two physiotherapists, a podiatrist and a social worker. A website consultant designed the site for layout, usability, acceptability, and interactive features.
The resulting prototype website was tested by seven parents and eight health professionals (four rheumatologists, two rheumatology nurse specialists, one physiotherapist, one clinical psychologist), to evaluate usability, navigation, structure, layout and content. Small changes were made to the website after this assessment.
Over the course of the website development but prior to trial commencement, the website was reviewed and updated to ensure user interfaces and content were current. The website is device adaptive, so suitable for use on computer, tablet and smartphone. The website has two main components: 1. information about JIA and its treatment. This comprises sections about: cause; diagnosis; JIA types and symptoms; how JIA changes with time; possible complications; the rheumatology team; everyday life, available treatments. It also includes videos of health professionals explaining JIA and its treatment plus video testimonials from parents about living with and caring for JIA as a family. 2. a JIA toolkit, based on cognitive-behavioural therapy which includes: psycho-education about thoughts, feelings, and behaviour following a diagnosis; cognitive re-structuring techniques to challenge unhelpful thinking to promote coping with JIA; problem-solving skills to promote coping with adherence issues and stressful events; strategies to promote effective communication with family members and the health care team; and pain management techniques including cognitive re-structuring, relaxation, distraction, and pacing. The toolkit includes a number of downloadable resources: problem-solving sheet; thought diary; breaking negative thought cycle sheet; reward chart; procedure contract template and certificate; visual timetable; audio relaxation sessions for children and adults."

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.
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 briefly explain why the item is not applicable/relevant for your study "The "JIA website for Parents" site was designed following [14]: a) a review of the literature on parents' experiences of having a child with JIA b) a review of websites that included information about JIA c) a focus group with six parents to ask their views on what should be included in the website d) two focus groups with a total of 12 healthcare professionals (HCPs) -six rheumatologists, five rheumatology nurse specialists, one clinical psychologist -to ask their views on what should be included in the website Website content was written by health professionals supported by a research assistant. The health professionals included: 13 rheumatologists, four rheumatology nurse specialists, two clinical psychologists, an occupational therapist, an ophthalmologist, two physiotherapists, a podiatrist and a social worker. A website consultant designed the site for layout, usability, acceptability, and interactive features.
The resulting prototype website was tested by seven parents and eight health professionals (four rheumatologists, two rheumatology nurse specialists, one physiotherapist, one clinical psychologist), to evaluate usability, navigation, structure, layout and content. Small changes were made to the website after this assessment. Over the course of the website development but prior to trial commencement, the website was reviewed and updated to ensure user interfaces and content were current."

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).
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 briefly explain why the item is not applicable/relevant for your study "Over the course of the website development but prior to trial commencement, the website was reviewed and updated to ensure user interfaces and content were current."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information 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 briefly explain why the item is not applicable/relevant for your study "Website content was written by health professionals supported by a research assistant. The health professionals included: 13 rheumatologists, four rheumatology nurse specialists, two clinical psychologists, an occupational therapist, an ophthalmologist, two physiotherapists, a podiatrist and a social worker. A website consultant designed the site for layout, usability, acceptability, and interactive features.
The resulting prototype website was tested by seven parents and eight health professionals (four rheumatologists, two rheumatology nurse specialists, one physiotherapist, one clinical psychologist), to evaluate usability, navigation, structure, layout and content. Small changes were made to the website after this assessment." 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

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 briefly explain why the item is not applicable/relevant for your study not applicable to this 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.
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 briefly explain why the item is not applicable/relevant for your study The website is not publicly available so this is not applicable

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 specific 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).
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 briefly explain why the item is not applicable/relevant for your study "those allocated to the intervention arm were given free unlimited password-protected access to the website"

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.
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 briefly explain why the item is not applicable/relevant for your study "those allocated to the intervention arm were given free unlimited password-protected access to the website"

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).

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 briefly explain why the item is not applicable/relevant for your study there was no human involvement -the intervention was delivered only by website 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 briefly explain why the item is not applicable/relevant for your study no prompts/reminders were given to use the 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. 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 briefly explain why the item is not applicable/relevant for your study not applicable -there were no cin-interventions 6a) Completely defined pre-specified 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 briefly explain why the item is not applicable/relevant for your study "After providing consent, participants were given baseline questionnaires to complete in clinic or at home and return to the trial co-ordinating centre (freepost envelope provided). A link to an online version of the questionnaire was also provided so parents could choose their preferred completion mode." "Trial Measures (See Table 1 respectively) were collected but will be reported separately from the current paper, which focuses on the trial outcomes.
Child data: Information about participants' children with JIA (gender; age; JIA subtype; date of diagnosis; core outcome variables (number of inflamed and limited joints, erythrocyte sedimentation rate, Child Health Assessment Questionnaire, parent global rating, physician global rating)[23]; medication; and any related comorbidities at the time of recruitment were gathered by the clinical sites and sent securely to the trial co-ordinating centre. Follow up: At 4 and 12-months post-randomisation, the trial centre sent follow-up questionnaires both electronically and in hardcopy for participants to choose preferred completion method. Telephone and text reminders were sent if questionnaires were not returned within 2 weeks. Follow-up clinical data for the child (core outcome variables, medication and comorbidities) were obtained from trial sites' clinic notes closest to the follow-up timepoints." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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].

Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text This is described in Table 1 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text The current manuscript reports the trial outcomes. Another manuscript is being prepared that reports the process evaluation, including website usage. subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 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).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text The current manuscript reports the trial outcomes. Another manuscript is being prepared that reports the process evaluation, including qualitative feedback.
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 briefly explain why the item is not applicable/relevant for your study There were no changes to trial outcomes after the trial commenced. subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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.

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 briefly explain why the item is not applicable/relevant for your study "Both parents were invited to participate, therefore sample size calculation allowed for 'clustering' by household. The power calculation was based on the PIP primary outcome measure, assessed at 4 months post-randomisation. Standard deviations on the PIP frequency (PIP-F) and difficulty (PIP-D) scales were expected to be 25 [15]. Therefore 85 households per trial arm was considered adequate to detect a mean difference of 10 points with 80% power and 5% significance level, representing a medium effect size. This allowed for clustering by household, assuming an intra-cluster correlation of 0.5. Allowing for a 15% drop out, 100 households per trial arm (200 total) were needed." 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 briefly explain why the item is not applicable/relevant for your study not applicable -interim analyses not performed 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 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 briefly explain why the item is not applicable/relevant for your study "To minimise selection bias, participants were randomised by the trial co-ordinating centre after receipt of the completed baseline questionnaire. Blocked randomisation per site was performed using computer generated randomisation sequences. " 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 briefly explain why the item is not applicable/relevant for your study "To minimise selection bias, participants were randomised by the trial co-ordinating centre after receipt of the completed baseline questionnaire. Blocked randomisation per site was performed using computer generated randomisation sequences." 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 briefly explain why the item is not applicable/relevant for your study "Blocked randomisation per site was performed using computer generated randomisation sequences." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * 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 briefly explain why the item is not applicable/relevant for your study "Parents were invited to participate by their child's rheumatologist when attending a clinic appointment with their child. Interested parents had time to consider participation and opportunities to ask questions before providing written consent to site research staff." "To minimise selection bias, participants were randomised by the trial co-ordinating centre after receipt of the completed baseline questionnaire. Blocked randomisation per site was performed using computer generated randomisation sequences." 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).

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 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 briefly explain why the item is not applicable/relevant for your study "Allocation was concealed from clinical teams however, after allocation, it was not possible to blind the trial co-ordinator as the follow-up questionnaires contained additional questions about the website for intervention arm participants. Other members of the investigating team were blind to trial arm allocation. Participants were requested not to inform their child's clinicians of their trial arm allocation." 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".
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 briefly explain why the item is not applicable/relevant for your study Not applicable. There was only one intervention -the website -so it was clear to all participants whether or not they had received the 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 briefly explain why the item is not applicable/relevant for your study Not applicable -there was only one intervention 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 briefly explain why the item is not applicable/relevant for your study "Outcomes were compared using multi-level modelling with a random effect of household, and adjusting for the variable at baseline and any parent and child demographic characteristics that differed between trial arms. We explored the main effects of time, trial arm and their interaction, by entering trial arm, time, and the interaction between trial arm and time as fixed effects, using restricted estimate maximum likelihood method. Significant interaction terms were interpreted as indicating differential treatment effectiveness and explored with post hoc tests. Hedge's g was calculated for effect sizes of differences between trial arms at each follow-up."

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] 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 briefly explain why the item is not applicable/relevant for your study "Missing value analysis, examined item-level missing data and used scale authors' rules for dealing with missing data, where provided. If rules were not available, mean imputation within a scale was used when ≥50% of scale items were available. Little's missing completely at random test was conducted to indicate the appropriateness of further imputations. If levels of missing data on any scale or item were >10%, multiple imputation was conducted (m=10). Data from all time points (baseline, 4-months and 12-months) were used to predict missing data, but the three time-points were imputed separately and only for participants who provided data at that time-point. Resultant databases were analysed separately, then Rubin's rules [24,25] were utilised to combine the results from the 10 datasets. Responders (those who completed at least one follow-up) were compared with non-responders on baseline characteristics using logistic regressions." 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 briefly explain why the item is not applicable/relevant for your study "Significant interaction terms were interpreted as indicating differential treatment effectiveness and explored with post hoc tests." "Outcomes were compared using multi-level modelling with a random effect of household, and adjusting for the variable at baseline and any parent and child demographic characteristics that differed between trial arms."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline 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.

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 briefly explain why the item is not applicable/relevant for your study "Parents were invited to participate by their child's rheumatologist when attending a clinic appointment with their child. Interested parents had time to consider participation and opportunities to ask questions before providing written consent to site research staff. If their child with JIA was aged 8-12 years, the child's assent was obtained for their demographic and clinical data to be collected for the research."

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

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) 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 briefly explain why the item is not applicable/relevant for your study not applicable -the intervention was website only and we did not include other aspects such as a hotline 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 briefly explain why the item is not applicable/relevant for your study "Baseline questionnaires were returned by parents of 208 children ("households"). Five protocol violations were identified, leaving a final sample of 203 households, 100 randomised to intervention and 103 to control arm (Figure 1). Follow-up questionnaires were completed by 133 (65.5%) households at 4 months and 124 (61.1%) at 12 months." 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 briefly explain why the item is not applicable/relevant for your study "Baseline questionnaires were returned by parents of 208 children ("households"). Five protocol violations were identified, leaving a final sample of 203 households, 100 randomised to intervention and 103 to control arm (Figure 1). Follow-up questionnaires were completed by 133 (65.5%) households at 4 months and 124 (61.1%) at 12 months." Participants did not give reasons for not returning follow-up questionnaires.

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 figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study This is reported in Figure 1 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 42/55 subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) 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 briefly explain why the item is not applicable/relevant for your study "Between February 2016 and October 2018, 717 parents were assessed for eligibility and 326 consented to take part." "Follow up: At 4 and 12-months post-randomisation, the trial centre sent follow-up questionnaires" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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 briefly explain why the item is not applicable/relevant for your study not applicable -no such events occurred in the study period 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 briefly explain why the item is not applicable/relevant for your study not applicable -the trial was not stopped early. 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 briefly explain why the item is not applicable/relevant for your study These data are reported in Table 2 15-i) Report demographics associated with digital divide issues

15) A
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
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 briefly explain why the item is not applicable/relevant for your study Age, education and gender are reported in Table 2 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
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 briefly explain why the item is not applicable/relevant for your study Multiple imputation was performed so each analysis contains the full sample size.

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).

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 briefly explain why the item is not applicable/relevant for your study "Analyses were on an intention-to-treat basis." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 briefly explain why the item is not applicable/relevant for your study These data are reported in Table 3 and Figures 2 and 3. 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 definitions 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 defined (e.g., timeout after idle time) [1] (report under item 6a).
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 briefly explain why the item is not applicable/relevant for your study Not applicable -the current manuscript reports the trial outcomes. A separate manuscript is being prepared that reports the trial process evaluation.
Does your paper address CONSORT subitem 17b? * 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 briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * 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 briefly explain why the item is not applicable/relevant for your study Not applicable -we did not conduct subgroup analyses

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).
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 briefly explain why the item is not applicable/relevant for your study Not applicable -the current manuscript reports the main trial outcomes; subgroup analyses have not been conducted. 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 briefly explain why the item is not applicable/relevant for your study Not applicable -the current manuscript reports the main trial outcomes. Another manuscript is being prepared to report the process evaluation that will include qualitative feedback.

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 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 briefly explain why the item is not applicable/relevant for your study "This RCT evaluated the "WebParC" website for parents of children with JIA. To our knowledge, this is the first website for parents of children with JIA that has undergone evaluation in a randomised controlled trial. The website was found to be successful in reducing child illness-related parenting stress and also promoted a greater improvement in parents' self-efficacy in managing children's symptoms." 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 briefly explain why the item is not applicable/relevant for your study "The primary target of WebParC was parenting stress rather than mental health; using online approaches to support the mental health of parents of children with JIA may require a greater focus on parents' psychological well-being than we were able to achieve in WebParC."

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. 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 briefly explain why the item is not applicable/relevant for your study "Limitations of the study, in common with interventions of this type, include that it was not possible to blind participants to trial arm allocation. Although requested not to inform their child's clinicians of their allocation, it is not possible to know if all participants followed this request. A proportion of parents who consented to participate in the trial did not return the baseline questionnaire and were therefore not randomised. The follow-up response rates were also lower than expected. Parents may have forgotten or not prioritised questionnaire completion; when reminders and a small incentive were introduced mid-trial, rates of baseline and follow-up questionnaire return improved. Another possibility is that although parents consented to the trial when they were in clinic, taking part in research about their own well-being, rather than their child's, was not a priority for them. Parents who did not return the baseline questionnaire may also have been reluctant to answer detailed questions about their own and their child's wellbeing. These issues will need to be considered in future studies of this type.
In common with other research[34], fathers were less likely to participate, which occurred in this trial because they were less likely than mothers to attend the clinic. It was not possible to establish whether non-participating fathers may have been given access to the website by participating partners. The small number of cases where both parents participated meant we were unable to cluster by household in our analyses.
Primary analyses with the PIP scales utilised a P<.05 value for significance as per the protocol. For secondary analyses on additional scales we did not adjust the p-value of <0.05 to allow for multiple testing so caution while interpreting should be taken. It is notable however, that the pattern of our findings, even where not statistically significant, were mostly in the direction favouring the Intervention arm therefore it is unlikely that our significant findings reflect type I error."

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 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 briefly explain why the item is not applicable/relevant for your study " In conclusion, this intervention shows potential value for reducing illness-related parenting stress. Online interventions should be a priority as they are low cost, easy to access, replicable and can offer a preventative approach to a large number of parents. "

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.
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 briefly explain why the item is not applicable/relevant for your study Not applicable -we did not include prompts and have not recommended changes outside the RCT setting. 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 briefly explain why the item is not applicable/relevant for your study "Full trial protocol available from corresponding author."

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist 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 briefly explain why the item is not applicable/relevant for your study

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial 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.

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 briefly explain why the item is not applicable/relevant for your study "Conflicts of Interest None declared" yes, major changes yes, minor changes no yes no Other: As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

Your answer
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

At least two and a half hours
As a result of using this checklist, do you think your manuscript has improved? *