A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology

Kaylin White; Samuel S. Han; Angela Britton; James Hendrix

doi:10.1371/journal.pone.0284738

Peer Review History

Original SubmissionApril 26, 2022
1 Sep 2022 Decision Letter - Lorena Verduci, Editor PONE-D-22-05428 Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Childrenwith Down Syndrome After Using Assistive Technology PLOS ONE Dear Dr. Han, 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. The manuscript has been evaluated by one reviewer, and his comments are available below. The reviewer has raised a number of major concerns that need attention. He requests additional information on methodological aspects of the study and revisions to the statistical analyses. Could you please revise the manuscript to carefully address the concerns raised? Please submit your revised manuscript by Oct 15 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, Lorena Verduci Staff 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. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. 3. Thank you for stating the following in the Acknowledgments Section of your manuscript: “This manuscript and supporting research were made possible in part by the support and participation of families within the Down syndrome community, and in part by the National Institute of Aging of the National Institutes of Health under award number RAG065081A. This includes 33% ($15,000) funded with federal money and 66% ($30,000) non-government sources. Non-government sources include LuMind IDSC Foundation ($ 15,000) and in-kind donation by MapHabit, Inc. ($ 15,000). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of health. We thank Kevin Xu and Yanan Wang for assistance and validation of statistical analyses, Paolo Aguila for assistance with figure illustrations, and Matthew Golden and Stuart Zola, co-Founders of MapHabit, Inc., and Hampus Hillerstrom, President and CEO of Lumind IDSC Foundation for their support that enabled the undertaking of this study.” We note that you have provided funding information that is not currently declared in your Funding Statement. However, 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: “This manuscript and supporting research were made possible in part by the National Institute of Aging of the National Institutes of Health under award number RAG065081A. This includes 33% ($15,000) funded with federal money and 66% ($30,000) non-government sources. Non-government sources include LuMind IDSC Foundation ($ 15,000) and in-kind donation by MapHabit, Inc. ($ 15,000). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of health. The funder MapHabit, Inc. had a role in the decision to publish the research. The funder LuMind IDSC foundation had no role in the conception and execution of the study. LuMind IDSC Foundation: https://www.lumindidsc.org/s/1914/20/home.aspx?gid=2&pgid=61 MapHabit, Inc.: https://www.maphabit.com/” Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 4. Thank you for stating the following in the Competing Interests section: “I have read the journal's policy and the authors of this manuscript have the following competing interests: Co-author, Kaylin White, MS, is a part-time consultant at MapHabit, Inc., the company that developed the assistive technology (the MapHabit System) that is used in this feasibility study. Ms. White receives compensation from MapHabit, Inc. Co-author, Samuel S. Han, B.A., is the Clinical Lead of MapHabit, Inc., the company that developed the assistive technology (the MapHabit System) that is used in this feasibility study. Mr. Han receives salary from MapHabit, Inc. The recruitment of subjects participating in the study was done independently of the authors, and carried out initially by the LuMind IDSC Foundation, a national support entity for families with Down syndrome. Statistical analyses of all data were carried out independently of the authors by a biostatistical resource department of an academic health center. Other than sharing the costs necessary to carry out the study, neither MapHabit, Inc., nor any MapHabit Inc. employees have any financial link to the LuMind IDSC Foundation, or to the independent biostatistical resource used in the study.” Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: ""This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. 5. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. 6. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well. [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: Yes ****** 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: The study aims to assess the significant behavioral impact of Assisted Technology on a group of children with Down Syndrome ages 7-17. Comments If it is a feasibility type of study, the word feasibility is to be added to the title. Data analyses section is to be placed in the method section and not in the results section. Line 115, the publisher name for the statistical software and its version to be stated. The level of statistical significance acceptance is to be stated. Line 116-117, the use of the statistical tests for what comparison in the context of this study and the name of the correlation test is to be clearly stated. Effect size could be employed to determine the effect of the intervention. For a feasibility study, significance testing is not encouraged unless the sample size is properly/adequately powered (Line 166, 'limited sample size') Results The percentage figures are to be presented with at least one decimal point. Line 117-119, Line 120-125, the data to be presented in table form. Figure 2A could be presented in table form with median and IQR values rather than using a bar chart. Line 122-123, the flow of the sentence requires improvement. Line 124, ‘two subgroups participants’ to be revised. To state ‘there was no statistical difference between the 18 and 8 participants.' Line 127, the name of the statistical test to be denoted in the Figure 2b footnote and in the data analyses section. Figure 2a, statistical test to be denoted in the figure footnote. P value could be displayed on the figure rather than mentioned in the title. Figure 2b, , and dark line to be denoted in the Figure footnote. CONSORT diagram to be revised and tweaked based on this study e.g. method, flow etc Not all references comply with the journal format. ****** 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. https://doi.org/10.1371/journal.pone.0284738.r001
Revision 1
3 Nov 2022 Author Response Dear Dr. Verduci, Thank you for giving us the opportunity to submit a revised draft of our manuscript previously titled “Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Children with Down Syndrome After Using Assistive Technology” to PLOS ONE, now titled “A Feasibility Study Demonstrating that Independence, Quality of Life, and Adaptive Behavioral Skills Can Improve in Children with Down Syndrome After Using Assistive Technology” (see Reviewer Comment 1). We are grateful for the time and effort that you and the reviewer have dedicated in providing valuable feedback on our manuscript. We appreciate the insightful comments from you and the reviewer. We were able to incorporate changes to reflect the suggestions that were provided. Below are the point-by-point responses to the editor and reviewer’s comments and concerns: Comments from Editor Comment 1: Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming Response: Thank you for this reminder. We have reviewed the manuscript and made changes that meet PLOS ONE’s style requirements. Comment 2: Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. Response: We have added the details mentioned in the comment above into the Methods section of the revised manuscript. Comment 3: We note that you have provided funding information that is not currently declared in your Funding Statement. However, 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… Please include your amended statements within your cover letter; we will change the online submission form on your behalf. Response: We have removed the funding information from the Acknowledgements section and included our amended statements within our new cover letter. Comment 4: Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: ""This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. Response: We confirm this does not alter our adherence to PLOS ONE policies on sharing data and materials. The updated Competing interests statement is included in our amended statements within our new cover letter. Comment 5: We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. Response: We confirm the data availability statement upon acceptance. Comment 6: Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well. Response: The full ethics statement has been included in the ‘Methods’ section of our manuscript file. Comments from Reviewer Comment 1: If it is a feasibility type of study, the word feasibility is to be added to the title. Response: The title has been revised to address this comment. Comment 2: Data analyses section is to be placed in the method section and not in the results section. Response: The suggested change has been made in the manuscript. Comment 3: Line 115, the publisher’s name for the statistical software and its version to be stated. The level of statistical significance acceptance is to be stated. Response: The suggested additions have been made in the manuscript. Comment 4: Line 116-117, the use of the statistical tests for what comparison in the context of this study and the name of the correlation test is to be clearly stated. Response: The suggested additions have been made in the manuscript. Comment 5: Effect size could be employed to determine the effect of the intervention. Response: See Response to Comment 6, below. Comment 6: For a feasibility study, significance testing is not encouraged unless the sample size is properly/adequately powered (Line 166, 'limited sample size') Response: We have added a section to the discussion indicating that our study was underpowered for some analyses (e,g., further stratification of subject groups, effect size). Nevertheless, as we have indicated, the findings evidenced important behavioral outcomes to be further explored, as well as the need for researchers to be prepared to devote considerable resources to recruitment efforts and participant retention. Comment 7: The percentage figures are to be presented with at least one decimal point. Response: The suggested change has been made in the manuscript. Comment 8: Line 117-119, Line 120-125, the data to be presented in table form. Response: The suggested change has been made in the manuscript. Comment 9: Figure 2A could be presented in table form with median and IQR values rather than using a bar chart. Response: The suggested change has been made in the manuscript. Comment 10: Line 122-123, the flow of the sentence requires improvement. Response: The suggested clarification has been made in the manuscript. Comment 11: Line 124, ‘two subgroups participants’ to be revised. To state ‘there was no statistical difference between the 18 and 8 participants.' Response: The suggested revision has been made in the manuscript. Comment 12: Line 127, the name of the statistical test to be denoted in the Figure 2b footnote and in the data analyses section. Response: The suggested additions has been made in the manuscript and figure. Comment 13: Figure 2a, statistical test to be denoted in the figure footnote. P value could be displayed on the figure rather than mentioned in the title. Response: The suggested additions and changes have been made in the manuscript and figure. Comment 14: Figure 2b, , ** and dark line to be denoted in the Figure footnote. Response: The suggested additions have been made in the figure. Comment 15: CONSORT diagram to be revised and tweaked based on this study e.g., method, flow etc. Response: We request that the CONSORT diagram that was previously submitted be removed. In PLOS ONE’s submission guidelines, the following statement is included: “Clinical trials must be reported according to the relevant reporting guidelines, i.e. CONSORT for randomized controlled trials, TREND for non-randomized trials, and other specialized guidelines as appropriate.” As our study is non-randomized, we believe the TREND statement checklist is appropriate. We have included a revised TREND statement in our resubmission. Comment 16: Not all references comply with the journal format. Response: We have adjusted the references to comply with the journal format. We look forward to hearing from you in due time regarding our submission and to respond to any further questions and comments you may have. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0284738.r002
10 Jan 2023 Decision Letter - Hugh Cowley, Editor PONE-D-22-05428R1A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technologyPLOS ONE Dear Dr. Han, 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 see the reviewers' comments below. When revising your manuscript, please ensure you fully address each of the reviewers' comments; in particular, please provide a detailed response to Reviewer #3's comment regarding the evaluation of the study participants' intellectual disability, and to the comments regarding clarity and presentational structure from Reviewer #2. Please submit your revised manuscript by Feb 20 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. 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, Hugh Cowley Staff 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) Reviewer #3: (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: Partly Reviewer #2: Partly Reviewer #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No Reviewer #3: 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: Yes Reviewer #2: Yes Reviewer #3: (No Response) ****** 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 Reviewer #3: 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: Interesting and important study! I appreciate reading the comments from the first reviewer and responses of the authors, which have improved the paper and made it clearer. Although I do have comments of my own. Abstract: The term ’nationally’ implies a reader knows where the study is conducted. Consider naming the country instead. Note: Personally, I find it difficult to use the framing “the first study on X”, because 1) How do you know that unless you have systematically searched the literature (as in a systematic review), 2) it puts a time stamp on the study, making it less interesting once another study on the same topic is published. It adds no scientific value, because there are thousands of studies that are first on a topic. Introduction/Research question: I don’t generally approve revising the wording in a research question (although the question you have is very vague) but I think the term significant should not be stated in the question. Is that the ‘test’ you think would answer whether AT is feasible or not? Another statistical approach would also serve as equally good (eg., Bayesian statistics). Introduction: I think the outline lacks a clear description of what is meant by feasibility of AT. There are no standards mentioned, conditions to be met (from models, theories, checklists) of what would count as a positive use of AT in everyday life. Additionally, there is little to no description of what kind of AT that is the focus of the study, and why you choose to study the MapHabit System over other technologies, and why the chosen technology may be a good fit for people with Down’s syndrome (other than resemblance to Alzheimer’s). Quality of life is also not mentioned. With this being said, many of the points I have raised are presented in the Methods section, and I think the outline of the paper is a bit confusing. I would have preferred describing and provide the rationale for each construct/the feasibility take in the Introduction section, which would make the Method section follow more logically. I am not familiar with this standard/format or what it is called. Method section General: the Enrollment, consent, & clinical trial registration section would be a lot easier to read if there were subheadings. L54: Name the country L115: You write: “This single-arm repeated measures design permitted the participants to serve as their own controls.” No, I don’t think the design allow for them being their own controls just because you measure pre- and post intervention (look up the designs in eg., Shadish, Cook and Campbell). Eg., in single subjects design you have multiple measurements to be able to observe a change more reliably bc a change in any of the measurements may be due to other reasons than the intervention. Consider removing that argument or provide a clearer description, number of measurement points etc. L130-135: Provide rational of why you used non-parametric tests. They are less sensitive than parametric tests for observing change, for example. Additionally: You write “1-sample t-test was used to compare scores against the null hypothesis (score of ‘3’). I am confused”. A one-sample t-test can be used to compare a point estimate (from your sample) to a fixed value. Consider explaining this more clearly, eg., if you test against the score 3. Also, in the results section you write: “one-sample Wilcoxon test”. Is this correct? Method and Results You have not mentioned the attrition or analysed what that meant for your conclusions. I think this is important because 23 participants were ‘lost’ and five expressed no desire to continue. The sample you have analysed are the ones that are ‘sufficiently satisfied’ because they fulfilled the trial, I guess. On the positive side, you analyse those that did not progress, but I think a general take is needed that includes all participants entering the study. I think a conflict of interest statement should be added to the manuscript. Explanation for the review questions with a 'No' Q2, 3: If authors adress my comments these will be turned into a 'Yes' Q5: Language is fine, but I have questions on the format/outline of the paper. If adequately met, this will also turn into a 'Yes' Reviewer #3: This well written research paper focuses on the use of AT from children with DS - It is suggested authors to give more information about the evaluation of their intellectual disability; the results may differ according the severity ****** 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 Reviewer #3: Yes: Aspasia Serdari ******** [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. https://doi.org/10.1371/journal.pone.0284738.r003
Revision 2
17 Feb 2023 Author Response Dear Mr. Cowley, Thank you for giving us the opportunity to submit a revised manuscript titled “A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology” to PLOS ONE. We are grateful for the additional time and effort that you and the reviewers have dedicated in providing valuable feedback on our initial revised manuscript. Below are the point-by-point responses to the reviewers’ comments and concerns: Comments from Reviewer #2 Comment 1: “Abstract: The term ’nationally’ implies a reader knows where the study is conducted. Consider naming the country instead.” Response: We agree with the reviewer that ‘nationally’ is vague for an international audience. We have replaced all mentions of the word to the specific country: United States of America. Comment 2: “Personally, I find it difficult to use the framing ‘the first study on X’” Response: We understand the reviewer’s caution with framing a study as the first to investigate on a particular subject. We have reframed the study as contributing to the expansion of research in an area that is still relatively new. Comment 3: “I think the term significant should not be stated in the question” Response: Following the reviewer’s suggestion, we have removed the word ‘significant’ to reserve its use for discussing statistical outcomes. Comment 4: “Introduction: I think the outline lacks a clear description of what is meant by feasibility of AT…Additionally, there is little to no description of what kind of AT that is the focus of the study, and why you choose to study the MapHabit System” Response: We have included additional details that define feasibility for the scope of our study and provided further rationale for using the MHS for the intervention. Comment 5: “I would have preferred describing and provide the rationale for each construct/the feasibility take in the Introduction section” Response: To clarify the structure of the manuscript, we have made changes in the Introduction. In addition, we included new subheadings to the Method section, as suggested by the reviewer in the next comment. Comment 6: “Method section. General: the Enrollment, consent, & clinical trial registration section would be a lot easier to read if there were subheadings.” Response: We have added subheadings to this section for better organization. Comment 7: “L54: Name the country.” Response: The country (USA) is now named in the manuscript. It is now located in line 78. Comment 8: “L115…I don’t think the design allow for them being their own controls just because you measure pre- and post-intervention…Consider removing that argument or provide a clearer description, number of measurement points etc.” Response: We appreciate the reviewer’s comment. The sentences were removed and replaced to be more straightforward: “permitted us to obtain baseline measures and compare them with the post-intervention outcomes”. Comment 9: “L130-135: Provide rational of why you used non-parametric tests…Also, in the results section you write: ‘one-sample Wilcoxon test’. Is this correct” Response: We appreciate Reviewer #3’s discussion of the statistical aspects of the study. The Reviewer is correct, the test used for the analysis on line 136 should have been indicated as the Wilcoxon Signed Rank test, not the t-test. We have corrected the typo. Additionally, Reviewer #3’s query about why nonparametric tests were used for the analyses (particularly for the QOL analysis) encouraged a second look. For the present study, the data sets were generated from relatively small samples (and possibly skewed data, because of the nature of the diagnosis of the participants). Accordingly, it was likely that our samples would yield scores from dependent measures that would depart from normality and potentially violate assumptions inherent to parametric tests (Seigel, 1956; Leech et al., 2002). Additionally, small sample sizes, as in the present study, will not cause the results derived from nonparametric analyses to be misleading to the extent that small sample sizes and outliers unduly can affect parametric tests (Hollander and Wolfe, 1973; McSeeney and Katz, 1978). Taking these points together, we feel confident our use of nonparametric tests in this study, including the QOL analysis, is appropriate, and we thank the Reviewer for the stimulating query. Comment 10: “Method and Results. You have not mentioned the attrition or analysed what that meant for your conclusions.” Response: We agree with the reviewer that the attrition of our participants is a limitation of the study. This may be explained by the study being too burdensome in the COVID-19 pandemic environment. We have added this point as a limitation in the Conclusion. Comment 11: “I think a conflict-of-interest statement should be added to the manuscript.” Response: Per the guidelines of PLOS ONE, a conflict-of-interest statement has already been submitted to PLOS ONE separately. Comments from Reviewer #3 Comment 12: This well written research paper focuses on the use of AT from children with DS - It is suggested authors to give more information about the evaluation of their intellectual disability; the results may differ according the severity. Response: We believe that the reviewer’s point is a very important one, and further reinforces the importance of this feasibility study. Further studies that are more systematic, such as randomized controlled trials, will allow for more conclusive findings and the ability to stratify the participants by intellectual or developmental disability severity. The present study did not have sufficient power or number of participants. We have added this point as a limitation to our conclusions. Sincerely, Samuel S. Han Clinical Lead MapHabit, Inc., Atlanta, GA 30308 shan@maphabit.com Tel: 207-991-1955 References Hollander, M., & Wolfe, D. A. (1973). Nonparametric Statistical Methods (Wiley Series In Probability And Mathematical Statistics). Wiley. Leech, N. L., & Onwuegbuzie, A. J. (2002). A Call for Greater Use of Nonparametric Statistics. McSweeney, M., & Katz, B. M. (1978). Nonparametric statistics: Use and nonuse. Perceptual and Motor Skills, 46(3_suppl), 1023-1032. Messick, S. (1957). Nonparametric Statistics for the Behavioral Sciences. Sidney Siegel. McGraw-Hill, New York, 1956. 312 pp. $6.50. Science, 126(3267), 266-266. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0284738.r004
6 Mar 2023 Decision Letter - Steve Zimmerman, Editor PONE-D-22-05428R2A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technologyPLOS ONE Dear Dr. Han, 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. The manuscript has been evaluated by three reviewers, and their comments are available below. Although reviewer 3 is now satisfied with the revised manuscript, reviewers 1 and 2 still have some requests for clarification.Reviewer 1 requests some minor language edits with reference to the Wilcoxon test, and reviewer 2 would like additional detail regarding their earlier requests.Could you please revise the manuscript to carefully address the concerns raised? Please submit your revised manuscript by Apr 20 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. 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 Journal Requirements: 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. [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) Reviewer #3: 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: Partly Reviewer #2: Partly Reviewer #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No Reviewer #3: (No Response) ****** 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 #2: No Reviewer #3: 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 Reviewer #3: 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: Line 154, Line 177 and Figure 2, the name for one-sample Wilcoxon test or one-sample Wilcoxon signed-rank test to be standardised or alternatively one-sample Wilcoxon test (also referred as one-sample Wilcoxon signed-rank test) to be indicated. Reviewer #2: I cannot see h0w you have addressed some of the concerns I raised. Responses for comment 4 and 5 say you have added rationale and descriptions in the manuscript, which I cannot find. Also, the attrition is only mentioned as a limitation but no one knows how these participants' scores would have altered the conclusions. Still, the abstract does not mention this uncertainty. Reviewer #3: (No Response) ****** 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 Reviewer #3: Yes: Aspasia Serdari, Assoc Professor of child Psychiatry, Medical School, DUTH ******** [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. https://doi.org/10.1371/journal.pone.0284738.r005
Revision 3
22 Mar 2023 Author Response Dear Dr. Zimmerman, Thank you for giving us the opportunity to submit a revised manuscript titled “A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology” to PLOS ONE. We are grateful for the additional time and effort that you and the reviewers have dedicated in providing valuable feedback that will enhance the manuscript. Below are the point-by-point responses to the reviewers’ comments and concerns: Comments from Reviewer #1 Comment 1: Line 154, Line 177 and Figure 2, the name for one-sample Wilcoxon test or one-sample Wilcoxon signed-rank test to be standardised or alternatively one-sample Wilcoxon test (also referred as one-sample Wilcoxon signed-rank test) to be indicated. Response: We thank the reviewer for noting the inconsistency of naming the statistical analysis. We have clarified this by following the reviewer’s suggestion: “one-sample Wilcoxon test (also referred to as one-sample Wilcoxon signed-rank test)”. Comments from Reviewer #2 Comment 1.A: I cannot see how you have addressed some of the concerns I raised. Responses for comment 4 and 5 say you have added rationale and descriptions in the manuscript, which I cannot find. Response: We believe comment 4 and 5 from the previous review have been addressed in the last rendition of the manuscript, seen in the Introduction (line 38-40; 48-50; 53-54) and Methods (line 100-105; 109-115). Comment 1.B: Also, the attrition is only mentioned as a limitation, but no one knows how these participants' scores would have altered the conclusions. Still, the abstract does not mention this uncertainty. Response: We appreciate the reviewer noting the potential limitation of the incompletions seen in participation. We have clarified this as a limitation that could have affected the outcomes that we reported. This has also been addressed in the abstract. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0284738.r006
10 Apr 2023 Decision Letter - Vanessa Carels, Editor A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology PONE-D-22-05428R3 Dear Dr. Han, 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, Vanessa Carels Staff Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0284738.r007
Formally Accepted
15 May 2023 Acceptance Letter - Vanessa Carels, Editor PONE-D-22-05428R3 A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology Dear Dr. Han: 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. Vanessa Carels Staff Editor PLOS ONE https://doi.org/10.1371/journal.pone.0284738.r008

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