A film-based intervention to reduce child maltreatment among migrant and displaced families from Myanmar: Protocol of a pragmatic cluster randomized controlled trial

Amanda Sim; Tawanchai Jirapramukpitak; Stephanie Eagling-Peche; Khaing Zar Lwin; G. J. Melendez-Torres; Andrea Gonzalez; Nway Nway Oo; Ivet Castello Mitjans; Mary Soan; Sureeporn Punpuing; Catherine Lee; Pattraporn Chuenglertsiri; Th’Blay Moo; Eve Puffer

doi:10.1371/journal.pone.0293623

Peer Review History

Original SubmissionJune 6, 2023
4 Aug 2023 Decision Letter - Jianhong Zhou, Editor PONE-D-23-16654A film-based intervention to reduce child maltreatment among migrant and displaced families from Myanmar: Protocol of a pragmatic cluster randomized controlled trialPLOS ONE Dear Dr. Sim, 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 Sep 18 2023 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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The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes Reviewer #2: Partly ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 ****** 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: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This protocol for a randomized controlled trial addresses an important and understudied area of research—child maltreatment in migrant and displaced families, particularly in low- and middle-income countries (LMICs). It has the potential to fill a significant gap in the literature on the prevention of child maltreatment in vulnerable populations. The protocol clearly outlines the rationale, provides detailed information about the methods (including participants, measures, and procedures), and offers a precise plan for statistical analysis and discussion. The reasoning behind choosing a film-based intervention is clearly articulated, emphasizing its potential for cost-effective, large-scale implementation in resource-limited settings. The decision to use a pragmatic, superiority cluster randomized controlled trial will allow for the investigation of the intervention's effectiveness in the “real world.” I also appreciate the use of various measures (both parent reports and adolescent reports) to evaluate the primary and secondary outcomes of the intervention. Furthermore, the use of both quantitative and qualitative methods could offer valuable insights about intervention delivery, acceptability, perceived impacts, and potential mechanisms of change. Overall, I view the protocol very positively and I am looking forward to reading about the results of this important study. I have only one minor comment: How did the authors of the protocol ensure that the film is adequate for the needs and situations of families with children across such a wide age range, from 4 to 17 years? Reviewer #2: The manuscript is well-written and addresses the important social issue of child maltreatment through a novel approach, and with a vulnerable population. My questions and concerns about the manuscript are three-fold: 1) Why submit the article at this stage, before data has been collected and analyzed? While it appears to be a novel approach, the manuscript seems incomplete without an analysis of the results. I would recommend resubmitting the manuscript with the data analysis. 2) Why are so many different assessment tools used? I added up the possibility of 168 question items or more. Is all of this necessary and relevant to the study's aims? Further rationale and explanation would be helpful, along with an estimate of the number of questions, and the length of time required to implement and respond to the assessments. 3) Why is Burmese the only language being used (rather than Karen, Karenni, Chin, etc.)? Does use of the Burmese language have a potential political subtext for minority groups who might have experienced oppression by the government? You could directly address the demographics within the migrant populations, and the role of language in this type of research. Less significantly, please note slight differences in how the primary outcomes are described on p. 2 and p. 7. The primary outcomes could also be described in more detail, since it reads as though physical and emotional abuse are an intended primary outcome, rather than trying to prevent such behaviors. This seems like an interesting study that could ultimately have useful results, with lessons for other contexts. Thank you for your efforts to reduce child maltreatment. ****** 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. 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Revision 1
26 Sep 2023 Author Response Dear Dr. Zhou: We thank you for your consideration of our manuscript and for the constructive and useful comments from reviewers. We are pleased to submit detailed responses to the reviewers’ comments and a revised manuscript for your consideration. In addition to the revisions made in response to reviewers’ comments, we have also made the following revisions to the protocol and study design since our original submission due to the evolving conditions in the study setting. These revisions and their rationale are outlined below: 1. Removal of adolescent reports at T2: The original protocol specified that adolescent children of adult participants will be surveyed at T2. Since submitting the original protocol, security and extreme weather conditions in the study setting have made field data collection more challenging. Upon consultation with the field data collection team and local partner organizations, we decided to remove adolescent data collection from the study design. Analysis of adolescent-reported data would have been exploratory in any case, given that we would only be able to collect data from a subsample of children who met the eligibility criteria of being between 12 and 17 years old. Hence, we would not have had statistical power to conduct a robust analysis using adolescent reported data. Given the challenges in the study setting and mindful of the wellbeing of the field team, we therefore made the decision to drop the adolescent survey. We will continue to conduct focus group discussions with adolescents, as described in the protocol, to obtain qualitative perspectives and experiences of adolescents. 2. Inclusion of parent-reported child internalizing and externalizing symptoms at T2: The original protocol specified that adolescent-reported internalizing and externalizing symptoms would be assessed at T2 as an exploratory outcome. Given the decision to drop the adolescent survey, we decided to add parent-reported child internalizing and externalizing symptoms at T2 as an exploratory outcome. Parent-reported child internalizing symptoms will be assessed using the Mood and Feelings Questionnaire and externalizing symptoms will be assessed using the externalizing subscale of the Child and Adolescent Behaviour Inventory (CABI). Further details can be found in the revised manuscript. 3. Timing of T2 data collection: Given the challenging conditions in the study setting, we decided to shift T2 data collection to be 4-months post intervention rather than 3-months post intervention. This change will allow the field teams more time to track and survey participants as well as ensure staff are able to maintain their well-being. 4. Other: Additional edits have been made to further clarify the Statistical Analysis section of the protocol. These edits do not substantively change the approach to analysis. COMMENTS FROM REVIEWERS AND AUTHOR RESPONSES Reviewer #1 This protocol for a randomized controlled trial addresses an important and understudied area of research—child maltreatment in migrant and displaced families, particularly in low- and middle-income countries (LMICs). It has the potential to fill a significant gap in the literature on the prevention of child maltreatment in vulnerable populations. The protocol clearly outlines the rationale, provides detailed information about the methods (including participants, measures, and procedures), and offers a precise plan for statistical analysis and discussion. The reasoning behind choosing a film-based intervention is clearly articulated, emphasizing its potential for cost-effective, large-scale implementation in resource-limited settings. The decision to use a pragmatic, superiority cluster randomized controlled trial will allow for the investigation of the intervention's effectiveness in the “real world.” I also appreciate the use of various measures (both parent reports and adolescent reports) to evaluate the primary and secondary outcomes of the intervention. Furthermore, the use of both quantitative and qualitative methods could offer valuable insights about intervention delivery, acceptability, perceived impacts, and potential mechanisms of change. Overall, I view the protocol very positively and I am looking forward to reading about the results of this important study. I have only one minor comment: How did the authors of the protocol ensure that the film is adequate for the needs and situations of families with children across such a wide age range, from 4 to 17 years? Response to reviewer: Thank you for your review and feedback on the protocol. In response to your question, we worked closely with partner organization Sermpanya Foundation on the development of the script to ensure that the characters and parenting scenarios in the film addressed a wide age range and corresponding developmental stages. The film depicts two families, each with younger children (e.g. infant, 5-6 years) and older children (12-14 years). Scenes in the film depict different parent-child interactions that correspond to the child’s age and developmental stage. For example, scenes with younger children depict using play as way to foster learning, while scenes with older children focus on positive parent-adolescent communication to promote problem solving. We have edited the manuscript as follows to provide further details (please see page 10): “The characters and scenarios depicted in the film reflect different ages and developmental stages to ensure that the film would be relevant to families with children across a wide age range.” Reviewer #2 The manuscript is well-written and addresses the important social issue of child maltreatment through a novel approach, and with a vulnerable population. My questions and concerns about the manuscript are three-fold: 1) Why submit the article at this stage, before data has been collected and analyzed? While it appears to be a novel approach, the manuscript seems incomplete without an analysis of the results. I would recommend resubmitting the manuscript with the data analysis. Response to reviewer: Thank you for your review and feedback on the protocol. In response to your question, we are submitting the protocol for publication in line with international commitments to improve research standards by promoting transparency, reducing publication bias, and enhancing the reproducibility of study design and analysis (see for example the UK Medical Research Council policy on open research data: clinical trials and public health intervention studies, October 2016). Upon completion of data collection and analysis, we will prepare and submit a separate manuscript reporting study results. 2) Why are so many different assessment tools used? I added up the possibility of 168 question items or more. Is all of this necessary and relevant to the study's aims? Further rationale and explanation would be helpful, along with an estimate of the number of questions, and the length of time required to implement and respond to the assessments. Response to reviewer: Thank you for this question. The measures have been carefully selected to rigorously and robustly assess each of the primary, secondary, and exploratory outcomes theorized to be potentially impacted by the intervention. In addition, several measures (e.g. trauma exposure, daily stressors) are included to investigate potential moderating effects – for example, to examine if caregivers who have experienced more trauma benefit more or less from the intervention than caregivers who have experienced less trauma. There are approximately 100 items in the survey, which takes 1-2 hours to complete depending on the participants. This length is consistent with past surveys that the study team has conducted in this setting. We have added details about the survey length on page 15 of the revised manuscript. 3) Why is Burmese the only language being used (rather than Karen, Karenni, Chin, etc.)? Does use of the Burmese language have a potential political subtext for minority groups who might have experienced oppression by the government? You could directly address the demographics within the migrant populations, and the role of language in this type of research. Response to reviewer: Thank you for raising this very important point. We agree that conducting the study in Burmese only is a limitation and have now included this on page 25 of the revised manuscript. The decision to only use Burmese was due to practical considerations regarding time and resources. Unfortunately we did not have the ability to translate and administer the surveys in multiple languages. Less significantly, please note slight differences in how the primary outcomes are described on p. 2 and p. 7. The primary outcomes could also be described in more detail, since it reads as though physical and emotional abuse are an intended primary outcome, rather than trying to prevent such behaviors. Response to reviewer: Thank you for this helpful suggestion. We have now edited the description of the primary outcomes to clarify further. This seems like an interesting study that could ultimately have useful results, with lessons for other contexts. Thank you for your efforts to reduce child maltreatment. Response to reviewer: Thank you for taking the time to review the manuscript and for your thoughtful feedback. Reviewer #3 This is an impressive protocol. It is very difficult to plan for an implement RCTs to address child maltreatment, and set this up in for addressing maltreatment in a highly vulnerable population is impressive. It will generate important data about a primary prevention strategy – using film-based intervention to improve positive parenting and reduce physical and emotional abuse is important and much needed. High income countries also lack similarly robust controlled studies, so it will be important globally in a number of ways. Response to reviewer: Thank you for your review and feedback. We hope these revisions are satisfactory and look forward to a favourable response. Attachments Attachment Submitted filename: Response to Reviewers.pdf https://doi.org/10.1371/journal.pone.0293623.r002
17 Oct 2023 Decision Letter - Malgorzata Gambin, Editor A film-based intervention to reduce child maltreatment among migrant and displaced families from Myanmar: Protocol of a pragmatic cluster randomized controlled trial PONE-D-23-16654R1 Dear Dr. Amanda Sim, 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, Malgorzata Gambin Guest Editor PLOS ONE Additional Editor Comments (optional): I recently had the pleasure of reviewing your manuscript and I am pleased to inform you that I have been invited to act as a guest editor. I would like to thank you for the thoughtful and elaborate responses to my comments and those of the other reviewers. Your efforts have greatly contributed to the improvement of the manuscript. Congratulations! Reviewers' comments: https://doi.org/10.1371/journal.pone.0293623.r003
Formally Accepted
20 Oct 2023 Acceptance Letter - Malgorzata Gambin, Editor PONE-D-23-16654R1 A film-based intervention to reduce child maltreatment among migrant and displaced families from Myanmar: Protocol of a pragmatic cluster randomized controlled trial Dear Dr. Sim: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Malgorzata Gambin Guest Editor PLOS ONE https://doi.org/10.1371/journal.pone.0293623.r004

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