PONE-D-24-43923Evaluating the spillover effects of the Sugira Muryango home-visiting intervention on temperament of children aged (0.3-3years) Exposed to Domestic Violence: A cluster randomized controlled trial.PLOS ONE

Dear Dr. SIBOYINTORE,

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.

 In particular, there are two key questions highlighted by the referees.  One is the timing of the implemention of the program vis-a-vis the COVID-19 pandemic; implementation appears to be primarily in 2018, rendering the subsequent pandemic largely irrelevant to the question of why the effects are null (despite a long discussion in the text).  One referee wondered if the paper is in fact describing a subsequent implementation of the program.  This needs to be clarified and if implementation was in fact in 2018, then the pandemic presumably has little relevance.  A second major question is the eligibility criteria and whether households who entered the sample were only those experiencing domestic violence or not (and if not, the language of the paper's exposition needs to be adjusted).   There is also the need for a number of additional clarifications related to the intervention, the statistical power of the analysis given the small sample, the magnitude of the estimated effects, and the definition and measurement of temperament.

Please submit your revised manuscript by Feb 03 2025 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.

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PLOS ONE

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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: Yes

Reviewer #2: Partly

Reviewer #3: Partly

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

Reviewer #1: I Don't Know

Reviewer #2: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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

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Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

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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: The study is a good attempt. But you need to justify or clearly explain your study design. It is not yet very clear. In my comments, I have indicated some of the questions that could guide you towards that.

Reviewer #2: Thank you for providing the opportunity to review the manuscript. It is very welcome to see a program investigating the longer-term spillover effects that work with parents may have for children who were not the direct target of the original intervention.

However, there is one major discrepancy that is raised by the current version of the manuscript - which perhaps represents a larger issue, or simply the manner in which the study is presented. In the methodology, the study is presented as surveying a subset of original trial participants and their children (who were not included in the original trial) from a trial that evaluated the 2018 implementation of the Sugira Muryango program in Rwanda. In this way the study is measuring the longer-term impact of the 2018 program on younger siblings. Yet, in the discussion, it is noted several times that one of the reasons why the program may not have had a spillover effect is due to interruptions and/or poor quality implementation during the Covid-19 pandemic - which would suggest the study is measuring impacts of the program when implemented in 2020 or 2021, not 2018. It is therefore quite difficult to assess the quality of the paper with this major discrepancy. It is possible that there are multiple studies being written up at the same time, which may be contributing to these discrepancies.

If the study is in fact evaluating the longer-term impact of the 2018 implementation, any mention of the Covid-19 pandemic and disruptions to the program, and therefore that as a potential factor for the lack of findings should be removed. If it is in fact a later implementation of the program, this needs to be more clearly explained in the methodology.

I hope that my comments may be helpful as the authors revise their manuscript.

Other comments:

- The paper could do with some editing of English language and grammar throughout.

- The title of the paper suggests that you are measuring spillover effects among children "exposed to domestic violence", but this is not included or noted as a criteria in the study methodology. The programme does work with families where there may be domestic violence happening, but from the methodology it does not look as though those families were specifically chosen for this follow-on study. This should be removed from the title.

Background

- The literature review in the background jumps back and forth between violence against children and violence against women and their impacts. I would recommend that this be streamlined so that the data and impacts of each are clearly explained, and then you could note the common co-occurrence, risk factors, and consequences of both types of violence (how they intersect). There is also some repetition.

- One study cited in the background (lines 99-100) is presented as though it is a nationally representative study, but it was not. That should be made clear to the reader. The study suggests high rates of violence, but the context of the study should be provided to the reader.

- You may wish to include data from the 2019/20 DHS in Rwanda, which shows rising rates of intimate partner violence (IPV) compared to the 2014/15 DHS.

- Temperament - given that the focus of the study is on programmatic impacts on temperament, it could be useful to provide the reader with more context to why temperament is important and it's associations with other child development outcomes. It would also be valuable to note whether the original study measured temperament.

- The intervention - it would be useful to provide more background on the intervention and who it targets (i.e., eligibility criteria), and who delivered it (who were the coaches?) to provide the reader with more context for the programme and its potential impacts and pathways to change.

Methodology

- It would be good to provide more information on the study setting (i.e., districts/locations where the study took place and contextual information about those locations).

- It would be helpful to provide more information on how the study sample was selected - i.e., how you assessed who met the criteria? Was it using existing data from the trial, or did you have to reach out to families, etc.

- The paper notes that ethics approval was collected as part of the mother study (in 2022) - it would be helpful to understand how this study sits within that broader study - is that a study of a new implementation of the program?

- More information on the enumerators who collected data would be helpful (i.e., from an external research firm, or recruited and trained for this study) and the training they received (i.e., what it covered).

- There is some repetition in the description of the intervention across other parts of the paper.

Data analysis

- You mention that you controlled for "participation in other programs". It would be helpful to understand what parameters were put on this - e.g., did you ask whether they had participated in any other "parenting" programs or simply "programs"?

- Were you able to reach the intended study sample? Did anyone decline to participate or was anyone unavailable? A FLOW diagram would be useful to understand the process and sample included in the analysis.

Results

- The paper could be streamlined a bit to not repeat every finding that is included in a table, but to provide some of the top-line findings in the text.

- As noted above, it remains unclear why disruptions due to Covid-19 would have an impact on program implementation, when the methodology states that the program was implemented with these families in 2018 - unless that is incorrect. If the program was in fact implemented in 2018, then any reference to Covid-19 interruptions on program implementations should be removed. If you think that the stress and other factors caused by Covid-19 may have had an impact on parenting practices, that is relevant to include.

- One potential reason why no spillover effect may not be found, but which is not cited is that the study may not have had longer-term impacts on reducing family violence. Domestic violence can impact parenting practices and children' can also be directly impacted by the presence of domestic violence, even if they do not witness it directly.

- The validity of the instruments and the sample size are also raised. It could be helpful in the methodology section to describe more about the sample size determination and also the selection of instruments, and whether any testing or adaptation was made in Rwanda prior to use in this study.

Reviewer #3: Summary

This paper evaluates the spillover effects of a home-visiting intervention aimed at fostering early childhood development and reducing violence against children and intimate partner violence against caregivers. The intervention lasted 12 weeks and took place in 2018. Previous research has shown that the program reduced violence and improved child development using a randomized controlled trial. These results were observed immediately after the intervention and one year after the end of the program. In this paper, the authors evaluate the spillover effects of the program on the temperament of the younger siblings aged 3 months to 3 years at the time of the data collection in 2022. The authors employ a cluster randomized controlled trial to evaluate the impact of the program on three measures of child temperament (outcomes): Surgency, Negative emotionality, and Orienting capacity. All the measures of child temperament are self-reported by the caregivers. The estimates are statistically insignificant, suggesting that the home-visiting program had no statistically significant spillover effects on the temperament of younger siblings who were not directly exposed to the program.

Overall evaluation

This article studies the spillover effects of a home visiting program on the temperament of young children who were not directly exposed to the original intervention. While the original intervention did not focus on child temperament, it still had the potential to influence it by improving the mental health and behavior of caregivers and reducing violence within the home. The authors find that the estimates are not precisely estimated.

Main comments

1. The authors could expand the interpretation of the findings to provide the reader with more information and allow a deeper understanding of the estimated effects.

First, about the magnitude of the estimates: The estimates are statistically insignificant, but is the magnitude of the estimated effects large or small? It would be helpful to understand whether the estimated effect size is meaningful.

Second, are the estimates statistically insignificant because the experiment is underpowered? The authors write: “Lastly, the methodological considerations, including the measurement tools used to assess temperament and the statistical power of the study need careful examination.” (lines 341-342). They could expand on this to improve clarity and provide a more thorough description of the results. Could it be that the effect size is not large enough to be detected with the available sample of 247 children? Maybe the authors did a power analysis before the experiment that can help elucidate this point.

2. My understanding is that because the intervention ended in 2018, most (if not all) the children in this study were conceived and born after the end of the intervention. Should we worry that the intervention itself affected fertility choices, child spacing, etc.? Table 1 shows that the age composition of children is different in the treatment and control groups, with a “younger demographic in the control group and a concentration of participants in the 18-37 months category within the treatment group” (lines 269-270). Are these differences statistically significant? See also my comment below. Could they have been affected by the treatment (the 2018 home-visiting intervention)?

3. About the lack of results on temperament: Could it be that the effects of the intervention on harsh discipline and intimate partner violence also disappeared in the longer run (after 4 years, when the data on child temperament were collected)? In other words, could it be that the impact of the intervention faded over time, and could that be the reason for why there is no effect on child temperament?

4. Figure 1: Theory of Change. I am confused whether the 4-year post-intervention outcomes refer to the results of a study or hypothesized theoretical outcomes.

5. I would like to see a balancing table showing whether the characteristics of the children and their families are balanced in the treatment and control group, including a t-test showing whether the differences are statistically significant. Table 1 provides a step in that direction but it is incomplete because 1) few variables are included 2) the p-value of the test of equality between the means in the two groups is missing. For example, the table should also show balancing tests for the other control variable included in the regressions: participation in other school programs.

6. Regarding the control variables included in the regressions: it is not entirely clear why these are included. Is it only to improve the precision of the estimates? Or are the variables not balanced between the treatment and control groups? Regarding the participation in other school programs, could this variable also be affected by the home-visiting intervention? Is it measured at the time of the data collection in 2022?

7. I find the discussion (lines 297-345) confusing.

The authors argue that the COVID-19 pandemic may be the reason for why the spillover effects did not manifest. For example, they write:

“The pandemic significantly disrupted daily life and the implementation of interventions like SM.” (line 311).

“Mandatory lockdowns and social distancing altered the frequency and intensity of the home visits, crucial to the SM intervention” (lines 314-315).

And also, in the conclusions, they write: “The lack of significant findings underscores the need for a comprehensive re-evaluation of intervention approaches, particularly in light of challenges such as the COVID-19 pandemic, which may have disrupted the delivery and effectiveness of the program.” (lines 367-369).

I am confused by this argument because, if I understood correctly, the original home visiting intervention ended in 2018, much before the beginning of the pandemic. Therefore, the pandemic could not affect the design and implementation of the original home visiting program (SM), and it seems not possible for the pandemic to influence the findings through the mechanism of “Disruption of Intervention Delivery” (lines 312 and 313).

Maybe the authors mean that the pandemic disrupted the data collection in 2022? But in that case, wouldn’t the effect be similar in the treatment and control group?

The authors also argue that other mechanisms affect the results, such as Increased Family Stress and Potential Bias in Reporting (line 313). But the pandemic lockdown and the lack of interactions during the pandemic supposedly affected the control group and the treatment group in a similar way. Therefore, these factors should not affect the estimate of the treatment effect, unless they affect the treatment and control group in a different way.

Minor comments

1. Line 62: What is UC?

2. Lines 150-151: typos nautrition (should be nutrition), hygene (should be hygiene)

3. Line 212: kindly review this sentence; I think punctuation may be missing.

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Reviewer #1: Yes:  Alypio Nyandwi

Reviewer #2: No

Reviewer #3: No

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Attachments

Attachment

Submitted filename: My comment1.docx

PONE-D-24-43923R1Evaluating the spillover effects of the Sugira Muryango home-visiting intervention on temperament of children aged (0.3-3years) Exposed to Domestic Violence: A cluster randomized controlled trial.PLOS ONE

Dear Dr. SIBOYINTORE,

Thank you for submitting your manuscript to PLOS ONE.  I have now received feedback from two of the original referees, who have generally indicated they feel the manuscript has been appropriately revised.  However, one referee made an additional suggestion for further edits in the discussion section to contextualize the findings vis-a-vis existing literature; I agree this suggestion is important.  I would like to invite you to submit a revised version of the manuscript that addresses this final set of comments.

 The referee also points out that the language around bias introduced by COVID-19 remains unclear.  It seems that the scenario you have in mind is one in which there is some improvement in temperament but that caregivers fail to accurately report this shift in temperament in their children due to pandemic-related stress.  I am not sure how plausible this potential bias is, but I suggest you describe it explicitly.

Please submit your revised manuscript by Apr 05 2025 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,

Jessica Leight, PhD

Academic Editor

PLOS ONE

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Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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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 #3: All comments have been addressed

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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 #3: (No Response)

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

Reviewer #1: I Don't Know

Reviewer #3: (No Response)

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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: Yes

Reviewer #3: (No Response)

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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 #3: (No Response)

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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: I think the discussion sections should be strengthened by comparing these study findings with findings from similar studies. Their discussion focused only on the COVID-19 pandemic as if it were the only potential factor behind the lack of the spillover effect. What had other previous studies found?

I still think that interpreting the lack of the spillover effect by associating it with the pandemic may be misleading because you had the treatment and control group. So, there was no difference between the two groups. I do not see the importance of still bringing in COVID-19 because both the Treatment and Control groups experienced the pandemic similarly. Again, you should critically look into this before associating everything with COVID-19. I think the only explanation was the way the study was designed. You also allude to that it should be your next step/suggestion to utilize robust study design in the next similar studies.

Reviewer #3: (No Response)

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Reviewer #1: Yes:  Nyamdwi Alypio

Reviewer #3: No

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Evaluating the spillover effects of the Sugira Muryango home-visiting intervention on temperament of children aged (0.3-3years) Exposed to Domestic Violence: A cluster randomized controlled trial.

PONE-D-24-43923R2

Dear Dr. SIBOYINTORE,

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.

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Kind regards,

Jessica Leight, PhD

Academic Editor

PLOS ONE

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