The Baby Steps Web Program for the Well-Being of New Parents: Randomized Controlled Trial

Background New parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents. Objective This study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently. Methods The study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks’ gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples’ randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples. Results Selection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participants accessed their program more than once, with higher rates for mothers (133/248, 53.6%) than fathers (52/248, 20.9%; P<.001). The EPDS, quality of life, and social support did not show differential improvements between programs, but Baby Steps Wellbeing gave a greater linear increase in self-efficacy for support provision (P=.01; Cohen d=0.26) and lower reduction in relationship satisfaction (P=.03; Cohen d=0.20) than Baby Care alone. Mothers had greater linear benefits in parenting self-efficacy over time than fathers after receiving Baby Steps Wellbeing rather than Baby Care (P=.01; Cohen d=0.51). However, the inclusion of program type in analyses on parenting self-efficacy and relationship satisfaction did not improve model fit above analyses with only parent gender and time. Conclusions Three secondary outcomes showed differential benefits from Baby Steps Wellbeing, but for one (parenting self-efficacy), the effect only occurred for mothers, perhaps reflecting their greater program use. Increased engagement will be needed for more definitive testing of the potential benefits of Baby Steps Wellbeing for perinatal adjustment. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614001256662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367277


Article Preparation Status/Stage *
At which stage in your article preparation are you currently (at the time you fill in this form) not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet published Other: Overall, was the app/intervention effective? * 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: 1a) TITLE: Identification as a randomized trial in the title 1a) Does your paper address CONSORT item 1a? * 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 "Internetbased" 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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Title: "The Baby Steps web-based program..."

TITLE AND ABSTRACT 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").
subitem not at all important 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 No non-web elements in the intervention, except as detailed below, for participants at risk. 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 Abstract: "Effects of childcare information modules only (Babycare) and the full interactive CBT program (Baby Steps Wellbeing) were compared..." 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 Title: "...for wellbeing of new parents..." 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) subitem not at all important 1 2 3 4 5 essential Clear selection 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. offline), 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 offline 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 selfenrol). (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) subitem not at all important 1 2 3 4 5 essential Clear selection 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 Abstract: "...a universal self-guided digital program..." 1b-iv) RESULTS section in abstract must contain use data Even web-based information focused on new fathers is limited [16,17]." 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 The study had a parallel design: "This randomised controlled trial compared the efficacy of the full, interactive Baby Steps Wellbeing program (containing all modules and planning tools) with its Babycare informational tips alone over 6 months from the third trimester of pregnancy." Allocation was 1:1: "...the study had a recruitment target of 240 couples, but recruited 248 (124 in each arm)." 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 briefly explain why the item is not applicable/relevant for your study There were no methodological changes after the trial began.
3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 briefly explain why the item is not applicable/relevant for your study Ethical approval, inclusion criteria and recruitment: "Participants were coparenting, male-female couples aged 18 years and over who were expecting a single, first child who was at 26-38 weeks' gestation."

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].
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Under Web Programs: "No changes to either program were made during the study, and no major technical issues were encountered."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant.
In online-only trials, clarify if participants were 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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 There was no check on digital literacy.
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 Ethical approval, inclusion criteria and recruitment: Procedure: "After volunteers for the study registered online, they were emailed a link to the web-based consent form and eligibility screen.
Prospective participants could email or call the research team to ask questions about the trial. Following informed consent and initial automated confirmation of eligibility, they were given a link to selfcomplete the Baseline assessments. Both these and later measures were delivered via Qualtrics© (https:/ www.qualtrics.com) and stored separately from identifying data, using a numerical code for the couple plus a letter to signify father or mother. If a respondent screened positive for medium or high risk of major depression or self-harm (EPDS Item 10 ≥ 1 or mothers: total ≥ 10, fathers: ≥ 6) at either the Baseline or later assessments, they were contacted by a member of the research team, 4b) Settings and locations where the data were collected 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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 briefly explain why the item is not applicable/relevant for your study Patient information sheet (in appendices) states: "After both you and your partner have completed these questions, you will be assigned to one of two online programs: a) Babycare -this is an online program providing information and tips on areas relating to care of a young infant. You will also receive text messages 2, 4, 7 and 10 weeks after joining the study to remind you to visit and use the program. b) Wellbeing -this is an online program providing information and tips on areas relating to care of a young infant, as well as information and tips on taking care of yourself. You will also receive text messages 2, 4, 7 and 10 weeks after joining the study to remind you to visit and use the program.
The online program you are assigned to is up to chance but you and your partner will be using the same program. The aim of both programs is to help fathers and mothers in their adjustment to parenthood." 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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Data were collected online.
Procedure: "Both these and later measures were delivered via Qualtrics© (https:/ www.qualtrics.com) and stored separately from identifying data, using a numerical code for the couple plus a letter to signify father or mother." Web programs: "The database for Baby Steps was hosted at Queensland 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 Procedure: "Following informed consent and initial confirmation of eligibility, they were given a link to self-complete the Baseline assessments.
Both these and later measures were delivered via Qualtrics© (https:/ www.qualtrics.com) and stored separately from identifying data, using a numerical code for the couple plus a letter to signify father or mother...At 13 and 26 weeks, participants were sent automated emails with links to self-complete assessments online. All outcome and economic measures were readministered, together with details about the birth, a check on marital status and ratings of program satisfaction. Non-response resulted in emails or calls by a research officer, who was blind to condition, to provide further reminders." 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 "About" tab in Baby Steps: "Baby Steps is funded by beyondblue and was created at Queensland University of Technology by a team of psychologists, midwives and nurses." Insignia of both organisations are displayed at the bottom of the screen.

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 Acknowledgements: "The trial was funded by the men's health charity Conflicts of interest: "The authors declare that they have no competing financial interests."

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.
subitem not at all important 1 2 3 4 5 essential Clear selection

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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Web programs: "No changes to either program were made during the study, and no major technical issues were encountered."

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 Introduction: "Baby Steps...was developed by clinical psychologists and a midwife, with a particular focus on new fathers. It was based on unpublished qualitative research on the issues faced by ten couples with babies 3-6 months old and on semi-structured interviews with 21 recent parents who reviewed the draft program." In addition, one of the developers (Jeremy Gibson) was a recent father who commented on content.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of 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 Outliers and unusual patterns of responses in the data were checked before analyses were undertaken.

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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Screenshots are provided in appendices.

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 Screenshots are provided in appendices.

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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Introduction: "Baby Steps is a free, self-guided web program, which is optimised for multiple devices and aims to prevent distress and promote the wellbeing of new parents." Procedure: "Participants who undertook a follow-up assessment were given a store voucher for AUD20 for each completed assessment." Participants accessed the programs on their own device, wherever they wished. There was no charge for access.
Reviewers can access the program at http/ :babysteps.org.au interacting with the baby and adjusting to the new roles, plus one specifically focused on fathers, which covered ways they could support their partner and share childcare tasks. Selecting a tip in Baby Steps

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.
subitem not at all important 1 2 3 4 5 essential Clear selection

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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 The program was, in the Abstract: "...a universal self-guided digital program..." The only human involvement was, in Procedure: "If a respondent screened positive for medium or high risk of major depression or selfharm (EPDS Item 10 ≥ 1 or mothers: total ≥ 10, fathers: ≥ 6) at either the Baseline or later assessments, they were contacted by a member of the 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 Web programs: "Participants were not given advice on how many modules to access, and there was no limitation on the rate of module access." 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 Procedure: "All participants received automated text messages at 2, 4, 7 and 10 weeks post-allocation, reminding them to log into the program and select tips to apply. Texts for Baby Steps Wellbeing participants also included a recommendation to review their goals and plans. A final SMS for both groups thanked participants and expressed the hope that they found the website useful. These texts were for study participants only."

5-xi) Report any prompts/reminders used
6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 Procedure: "If a respondent screened positive for medium or high risk of major depression or self-harm (EPDS Item 10 ≥ 1 or mothers: total ≥ 10, fathers: ≥ 6) at either the Baseline or later assessments, they were contacted by a member of the research team, who implemented a risk Self-Efficacy used an average across items on feeding, sleep and settling, each of which were rated 0 (not at all confident) to 100 (extremely confident)…Self-efficacy for Support Provision to their partner used a single item (also rated 0-100)…Data on income, work time, productivity and healthcare were also collected, but will be reported in a separate paper." These were tested in the current study: "A new measure of Parenting Self-Efficacy used an average across items on feeding, sleep and settling, each of which were rated 0 (not at all confident) to 100 (extremely confident). At Baseline, the scale had high internal consistency (α= .94, Corrected item-total correlations = .78-.95).
Self-efficacy for Support Provision to their partner used a single item (also rated 0-100) that was moderately related to the CSI-16 (r = .33, P < .001) and inversely to the EPDS (r = -.33, P < .001)." "Overall program satisfaction, and the program's perceived relevance, usefulness and ease of finding what they wanted were self-reported at 3 months on a scale from 0 (not at all) to 100 (extremely), and average scores across those four items are reported below (in this sample, α = .93 and corrected inter-item correlations = .73-.91)." Other CHERRIES items are covered in other questions.
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. 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 Attrition was not taken into account in the calculation of sample size.
Adjusting for 80% retention would have given f = 0.226 (a medium effect size) being detected. However, retention was higher, at 84-89% at each assessment (See Figure 1 in the text).

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 No changes made.
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.

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 briefly explain why the item is not applicable/relevant for your study Procedure: "...a fully automated random allocation of the couple to a treatment condition by the Goji web-based trial management system [29]. Randomization was in permuted blocks, stratified by EPDS (screening negative for anxiety or major/minor depression: mother ≤ 7 and father ≤ 5; screening positive: father > 5 or mother > 7) [24]." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 briefly explain why the item is not applicable/relevant for your study The randomisation used a computer-derived random sequence. Procedure: "...a fully automated random allocation of the couple to a treatment condition by the Goji web-based trial management system [29].
Randomization was in permuted blocks, stratified by EPDS (screening negative for anxiety or major/minor depression: mother ≤ 7 and father ≤ 5; screening positive: father > 5 or mother > 7) [24]." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 Procedure: "...a fully automated random allocation of the couple to a treatment condition by the Goji web-based trial management system [29].
Randomization was in permuted blocks, stratified by EPDS (screening negative for anxiety or major/minor depression: mother ≤ 7 and father ≤ 5; screening positive: father > 5 or mother > 7) [24]." 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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Enrolment was online, and eligibility screening was automated. Research staff were only involved to answer questions relating to the trial prior to consent. Procedure: "After volunteers for the study registered online, they were emailed a link to the web-based consent form and eligibility screen.
Prospective participants could email or call the research team to ask questions about the trial. Following informed consent and initial automated confirmation of eligibility, they were given a link to selfcomplete the Baseline assessments." Randomisation was also automated.
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".
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Follow-up measures were self-assessed online. Non-response was addressed by a blinded research staff member.
Procedure: "Non-response resulted in emails or calls by a research officer, who was blind to condition, to provide further reminders."

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-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 comparator was not stated to be the control, but participants may have inferred it from the information sheet: "After both you and your partner have completed these questions, you will be assigned to one of two online programs: a) Babycare -this is an online program providing information and tips on areas relating to care of a young infant. You will also receive text messages 2, 4, 7 and 10 weeks after joining the study to remind you to visit and use the program.
b) Wellbeing -this is an online program providing information and tips on areas relating to care of a young infant, as well as information and tips on taking care of yourself. You will also receive text messages 2, 4, 7 and 10 weeks after joining the study to remind you to visit and use the program.
The online program you are assigned to is up to chance but you and your 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 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 The interventions shared the information tips on baby care.
Web Programs: "Participants randomised to the Babycare trial arm received the four informational modules giving information and tips on getting prepared, feeding, soothing and improving baby's sleeping habits.
A 'Get Help' tab provided a list of relevant digital or telephone support services.

Participants in the Baby Steps Wellbeing condition could also access
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 Statistical analysis: "The primary analyses adopted an intention-to-treat approach, using IBM SPSS 25 mixed models and a design incorporating Sex, Condition and Time (Baseline, 3 and 6 months), with random intercepts and a first-order autocorrelation between test occasions. While recruitment was of couples, individual parents comprised the units of analysis. For effect sizes in these analyses we report Cohen's d, using shared Baseline standard deviation units. In addition to analyses described in the protocol paper [21], we undertook secondary analyses guided by the wise interventions framework [30,31], comparing effects of participants scoring above and below the EPDS criteria used for stratification at Baseline (EPDS > / ≤ 7 for mothers; > / ≤ 5 for fathers), and examining effects within participants who logged into a program at least once." 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]).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 briefly explain why the item is not applicable/relevant for your study Statistical analysis: "… In addition to analyses described in the protocol paper [21], we undertook secondary analyses guided by the wise interventions framework [30,31], comparing effects of participants scoring above and below the EPDS criteria used for stratification at Baseline (EPDS > / ≤ 7 for mothers; > / ≤ 5 for fathers), and examining effects within participants who logged into a program at least once."

X26) REB/IRB Approval and Ethical Considerations [recommended as
subheading under "Methods"] (not a CONSORT item) 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 No imputation used--see previous answer.

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) subitem not at all important 1 2 3 4 5 essential Clear selection 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 Procedure: "If a respondent screened positive for medium or high risk of major depression or self-harm (EPDS Item 10 ≥ 1 or mothers: total ≥ 10, fathers: ≥ 6) at either the Baseline or later assessments, they were contacted by a member of the research team, who implemented a risk 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 Procedure: "After volunteers for the study registered online, they were emailed a link to the web-based consent form and eligibility screen." 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 See CONSORT diagram, Figure 1.
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 flow 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 briefly explain why the item is not applicable/relevant for your study See CONSORT diagram, Figure 1.
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 14a) Dates defining the periods of recruitment and follow-up 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 Ethical approval, inclusion criteria and recruitment: "Recruitment occurred between March and October 2015…"

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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 See CONSORT diagram, Figure 1.
14b) Why the trial ended or was stopped (early) 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.

15) A table showing baseline demographic and clinical characteristics
for each group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group 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" subitem not at all important 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 See Table 1.
Does your paper address CONSORT subitem 15? * 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 See Table 1.

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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Statistical Analyses: "The primary analyses adopted an intention-to-treat

approach…"
Tables and statistical tests show numbers or degrees of freedom for each analysis.
Secondary analyses: "Additional analyses were also undertaken on participants who accessed a program at least once (Supplementary

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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Statistical Analyses: "The primary analyses adopted an intention-to-treat approach…"

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).
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Program usage and satisfaction: "Access and use of the web programs were sub-optimal, especially for men. The median number of logins across the sample was 1 (Range: 0-23; 90th %ile = 5). Only 91 Babycare (37%) and 94 Wellbeing participants (38%; χ2 (1) = 0.08, P = .781) accessed the programs on two or more occasions. While 54% of women (n = 133) accessed the program at least twice, only 21% of men (n = 52) did so (χ2 (1) = 56.56, P < .001). These sex differences were seen on all continuous variables related to program usage. Baseline EPDS scores were not associated with number of program logins for either fathers or mothers (fathers: r = -.02, P = .772; mothers: r = -.01, P = .924).
Babycare only participants could access fewer modules, and so their mean number of modules accessed was lower than for Baby Steps Wellbeing. However, Baby Steps Wellbeing participants accessed fewer Babycare modules. Satisfaction with the programs was high among participants who accessed a program at least once (Median = 75, 92% ≥ 50; Table 2), with no differences due to Condition or Sex." 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 Not applicable-primary and secondary outcomes were continuous 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 Additional analyses: "Additional analyses testing whether higher EPDS at Baseline (EPDS > / ≤ 7 for fathers; > / ≤ 5 for mothers) changed the results are displayed in Supplementary Table 3. Consistent with regression to the mean, interactions between time and high/low EPDS were either statistically significant or approaching significance on all outcome variables. However, these analyses made little difference to the interpretation of the key results: effects for time were still seen on all outcomes except the Short MOS-SSS, and the only significant Condition x Time effect remained self-efficacy for support provision. Sex by time effects for the AQoL-8D and self-efficacy for support provision now lost significance, and there now were no significant three-way-interactions between condition, sex and time.
Additional analyses were also undertaken on participants who accessed a program at least once (Supplementary Table 4). Time and Condition by time effects were equivalent to the main analyses. Only self-efficacy for parenting now had a significant sex by time effect, and again there were no significant three-way-interactions between Condition, Sex and Time."

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 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 Additional analyses: "Additional analyses were also undertaken on participants who accessed a program at least once (Supplementary 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 qualitative data were obtained.

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No privacy violations or other significant issues were encountered.
Web programs: "…no major technical issues were encountered…" 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

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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Conclusion: "A major contributor to this result might have been a low level of program access and engagement in the self-guided program. Increasing that engagement and access will be a prerequisite to further evaluation of the program's effects on reduced depressive symptoms or increased wellbeing of new parents." 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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 Strengths and Limitations: "To our knowledge, this was the first controlled trial that specifically attempted to engage fathers in a digital perinatal intervention and provided an interactive module especially for them. The trial had a substantial sample size and very high retention in assessments, although its predominant recruitment through antenatal classes and the sample's high rate of university education may limit the generalizability of results to populations who were less highly educated or engaged in learning about birthing and childcare. Randomization was via an automated trial management program that ensured equivalence across conditions of the EPDS scores at Baseline. Assessments were online, and follow-up research staff were blind to condition. Analyses were by intention-to-treat, with secondary analyses examining effects in participants who accessed the program. However, the study did not have a standard or no-treatment control, which limits the ability to make conclusions about the benefits from both interventions, although the low level of program usage rendered such effects unlikely. That low level of usage also prevented assessment of effects from the intervention's

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 subitem not at all important 1 2 3 4 5 essential Clear selection 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.
subitem not at all important 1 2 3 4 5 essential Clear selection 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 Strengths and Limitations: "The trial had a substantial sample size and very high retention in assessments, although its predominant recruitment through antenatal classes and the sample's high rate of university education may limit the generalizability of results to populations who were less highly educated or engaged in learning about birthing and childcare."

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 briefly explain why the item is not applicable/relevant for your study 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 in Discussion, but under web programs: "These texts were for study participants only." If the trial had had more positive results, this issue would have been highlighted as a factor that may reduce impact in routine application of the program." 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 briefly explain why the item is not applicable/relevant for your study Acknowledgements: "The trial was funded by the men's health charity Movember through beyondblue (Project Grant KAVA11NPD). The sponsor had no role in the development of the program, the design, conduct or analysis of the trial, or to this manuscript."

X27) Conflicts of Interest (not a CONSORT item)
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 21.