PONE-D-21-31294Efficacy of a Randomized Controlled Trial of a Perinatal Adaptation of COS-P in Promoting Maternal Sensitivity and Mental Wellbeing among Women with Psychosocial VulnerabilitiesPLOS ONE

Dear Dr. Røhder,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Feb 18 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Anna Palatnik, M.D.

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at 

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Thank you for stating the following in the Acknowledgments/ Funding Section of your manuscript: 

The entire project (design, data collection, data analysis, interpretation of data and interpretation of data) is funded by The Capital Region of Copenhagen. A representative from The Capital Region was part of the steering committee of the project. The steering committee support the implementation of the intervention. The steering committee was not involved in data collection, data analysis, interpretation of data, writing the report nor the decision to submit the report for publication.

Please note that funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. 

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: 

The entire project (design, data collection, data analysis, interpretation of data and interpretation of data) is funded by The Capital Region of Copenhagen. A representative from The Capital Region was part of the steering committee of the project. The steering committee support the implementation of the intervention. The steering committee was not involved in data collection, data analysis, interpretation of data, writing the report nor the decision to submit the report for publication.

Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 

3. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability.

Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized.

Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access.

We will update your Data Availability statement to reflect the information you provide in your cover letter.

4. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. 

5. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Abstract

- typo in line 20: 'woman' instead of 'women'.

- typo in line 28: 'midwifes' instead of 'midwives' - and in the rest of the manuscript, e.g. line 107.

- the results paragraph of the abstract should include some numerical results, specifically the estimates of effect for key outcomes with 95% confidence intervals and p-values; perhaps including a sentence on the total number of women recruited.

Background

- line 74: please report the magnitudes of the 'medium effect sizes' mentioned here.

- line 80: please state objectively what the 'promising results' were.

Methods

- Procedures - should be consistently reported in the past tense like the rest of the manuscript. The beginning is reported in past tense, but sections such as line 130-135 are in the present tense.

- Intervention - the 'perinatal adaptions' to the COS-P intervention mentioned in line 141 should be clearly described.

- the CIB outcome should be described in a more detail. It is not clear how it is scored (if it is in fact a score), what is the measurement scale, what are the normal ranges, does it have any components/items/domains and if so how are they scored, etc. The same detail should be included for the secondary outcomes.

- statements in lines 152-153 about the Cronbach's alpha and in 158 about the ICC are results and should be reported in the results section.

- the sample size is not well described, partly because the primary outcome is not well described either. If the primary outcome is continuous, then the sample size calculation should include some idea about what the expected mean and SD of the outcome in the control group (plus the difference to be detected). You should also state whether the level of significance is for a one-sided or two-sided test.

- as this is a randomised trial, you should not conduct tests comparing descriptive characteristics between the groups (line 197-199).

- for the same reason above, any adjustment in the analysis should not normally be based on whether there are differences in baseline characteristics; however, design factors such as the stratification variables should be adjusted for.

Results

- given my comments above regarding analysis of a randomised trial, the results on line 233-234 about between group differences, and the p-value column on Table 1 (and the footnote) should be removed.

- Table 1 should report means and standard deviations (SD) for continuous characteristics. It is unclear whether the quantities reported against EPDS are the mean and standard deviation. Table 1 should also be clear when reporting counts and proportions of categorical variables, and explicitly state this.

- Table 2 should report means and standard errors (SE) for continuous outcomes. The 'range' column is not necessary here, and should have been included in the description of the measures (see comments above)

- again in Table 2, for outcomes with domains/components, p-values should generally be reported for the total or overall score, not the components, as this constitutes multiple testing which then warrants corrections that are difficult do to in this small study.

- for outcome measures where you have baseline values, instead of conducting an analysis on the change-from-baseline measure, you should ideally conduct an analysis on the post-intervention measures and adjust for the baseline measures (i.e. analysis of covariance ANCOVA). This is the most statistically-efficient way to analyse these outcome.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PONE-D-21-31294R1

Efficacy of a Randomized Controlled Trial of a Perinatal Adaptation of COS-P in Promoting Maternal Sensitivity and Mental Wellbeing among Women with Psychosocial Vulnerabilities

PLOS ONE

Dear Dr. Røhder,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

==============================

As we only had comments from one reviewer in the first round of reviews, we sought additional input from a subject expert. The first reviewer is satisfied with your revisions, but the second reviewer has  some requests for clarification on a number of issues. Please see those comments below.

==============================

Please submit your revised manuscript by Oct 02 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Steve Zimmerman, PhD

Associate Editor, PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: In line 274 you have stated that the means and standard deviations are reported in Table 2. However the column titles of Table 2 appear to indicate that you are reporting standard errors (which is the correct thing to report here, as this is a table of inferential results). So either (1) correct the statement on line 274 or (2) report standard errors in Table 2 if they are in fact standard deviations and correct the statement on line 274.

Reviewer #2: The paper is a randomized controlled trial exploring the efficacy of the COS-P intervention, adapted to the perinatal period, in improving several aspects of mothers’ mental health and well-being. Despite the topic is interesting, there are several aspects that should be clarified, before resubmitting the paper:

1. The primary aim of the study is to increase of “maternal sensitivity in interactions with the infant nine months after birth”. The concept of “maternal sensitivity” is not really clear to me. No explanation of this is provided in the introduction and/or in the method section. Could the authors better specify what they intend for “maternal sensitivity”. Similarly, among secondary outcome it is reported that the intervention could lead to a “better maternal ability to mentalize”; could this issue be better described?

2. One of the inclusion criteria is that mothers had to present “psychosocial or social vulnerabilities” identified by the general practitioner. This is too vague and undefined. Please specify in detail the inclusion criteria, since this is a RCT and inclusion criteria are crucial to select the right population to be treated.

3. The experimental intervention is poorly described. Authors should explain in details the experimental intervention (i.e., how many sessions were provided to mothers, what was the content of sessions, how session were structured, etc.), and report the appropriate citation to the available manuals.

4. The main outcome was assessed through the CIB. Is this global rating scheme validated? Were raters trained in the use of the assessment instruments? Moreover, authors should specify whether mental health professionals who performed the assessments were blinded to mothers’ allocation to the experimental vs. control group.

5. I was not able to find thought the manuscript when women were assessed for the first time (I suppose during pregnancy) and when they were reassessed. Could the author better specify this issue?

6. In the result section, it is reported that 35 out of 76 women presented mental health problems at pregnancy and 28 of them were on psychiatric or psychological treatment. This is a bit confusing, since authors have excluded from the recruitment women with major psychiatric problems. Could you clarify this issue?

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Efficacy of a Randomized Controlled Trial of a Perinatal Adaptation of COS-P in Promoting Maternal Sensitivity and Mental Wellbeing among Women with Psychosocial Vulnerabilities

PONE-D-21-31294R2

Dear Dr. Røhder,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Maiken Pontoppidan

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for addressing the issues raised by the reviewers.

I have accepted the paper but I suggest that you look at comment 2 and 3 from reviewer 2 and see if you can incorparate these two comments in the final paper.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: (No Response)

Reviewer #2: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #2: Thank you for this revised version of the paper, which is improved compared to the previous one. However, I have further minor comments that should be addressed:

1. in the inclusion criteria, authors state that patients were recruited whether " they were: 1) identified as having psychological or social vulnerabilities by the general practitioner or the hospital. This is in line with official Danish Health Care recommendations. The group consists of women with complex psychological/psychiatric problems and/or difficult social problems with a need for interdisciplinary perinatal care." Although there is an appropriate reference, it would help the reader to specify the kind of difficulties considered. Have you also carried out some psychiatric full-examination in order to assess the presence of any mental disorders?

2. IN the introduction, authors should consider to quote some recent papers published on perinatal mental health (please see e.g., Howard LM, Khalifeh H. Perinatal mental health: a review of progress and challenges. World Psychiatry. 2020 Oct;19(3):313-327. doi: 10.1002/wps.20769. PMID: 32931106; PMCID: PMC7491613; Glover V. Prenatal mental health and the effects of stress on the foetus and the child. Should psychiatrists look beyond mental disorders? World Psychiatry. 2020 Oct;19(3):331-332. doi: 10.1002/wps.20777. PMID: 32931095; PMCID: PMC7491637)

3. in the discussion, authors should add a comment on the feasibility in clinical routine practice of the proposed intervention, also comparing it with other psychosocial interventions available.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

**********