{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:09:39Z","timestamp":1772168979857,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/hrbopenres.13973.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T00:00:00Z","timestamp":1738281600000}},{"DOI":"10.12688\/hrbopenres.13973.2","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T00:00:00Z","timestamp":1738281600000}}],"reference-count":66,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T00:00:00Z","timestamp":1738281600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010414","name":"Health Research Board","doi-asserted-by":"publisher","award":["DIFA2023001"],"award-info":[{"award-number":["DIFA2023001"]}],"id":[{"id":"10.13039\/100010414","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["hrbopenresearch.org"],"crossmark-restriction":false},"short-container-title":["HRB Open Res"],"abstract":"<ns3:p>Background In areas of social disadvantage up to 40\u201350% of children enter preschool with speech and language skills significantly poorer than would be expected for their age. The Happy Talk trial tests if a community embedded, targeted selective speech and language programme that simultaneously engages with parents and early childhood educators, (1) improves language outcomes in children aged between 2 years 10 months and 6 years and (2) is cost effective for the health care system. Method The Happy Talk trial is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre\/school settings serving socially disadvantaged communities, in Ireland. Seventy-two clusters will receive the intervention (12 participants per cluster). Parents and pre\/school staff engage in group training and coaching in the form of 12 1-hour sessions for parents and four staff workshops, over the course of the pre\/school year. Training\/coaching includes core interaction skills (modelling, expanding, balancing questions and comments), early literacy and phonological awareness. Blinded assessments pre- and immediately post-intervention and at 6 months follow up, will measure the primary outcomes of children\u2019s receptive and expressive language and functional impact, and secondary outcomes of quality of life. Parental responsiveness and educator-child interactions will also be evaluated. Discussion This robust study evaluates a public health approach to the delivery of speech language and communication intervention in the \u2018real world\u2019 in the community, which focuses on prevention and equity of access. Pilot work indicates that the programme is feasible, acceptable to parents and staff, cost effective, and suitable for implementation at scale. The trial includes a process evaluation, a well-developed economic evaluation and the outcomes are directly relevant to children, families and educators. This work has the potential to improve the long-term outcomes and life chances of people living in social disadvantage. Trial registration clinicaltrials.gov NCT06460090 Trial Management There is a formal governance structure to oversee the conduct and running of the trial, consisting of a trial management group and a steering committee. More details on the composition, roles and responsibilities of each committee can be found in the supplemental material.<\/ns3:p>","DOI":"10.12688\/hrbopenres.13973.3","type":"journal-article","created":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T07:20:07Z","timestamp":1738308007000},"page":"65","update-policy":"https:\/\/doi.org\/10.12688\/hrbopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating a targeted selective speech, language, and communication intervention at scale \u2013 Protocol for the Happy Talk cluster randomised controlled trial."],"prefix":"10.12688","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9715-3788","authenticated-orcid":false,"given":"Pauline","family":"Frizelle","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aoife","family":"O'Shea","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3062-0692","authenticated-orcid":false,"given":"Aileen","family":"Murphy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darren","family":"Dahly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9058-9813","authenticated-orcid":false,"given":"Cristina","family":"McKean","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2025,1,31]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"1644-1645","DOI":"10.1016\/j.athoracsur.2015.11.024","article-title":"Adjust for multiple comparisons? 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/hrbopenres.15338.r42876, Heidi Feldman, Stanford University, Stanford, California, 25 Nov 2024, version 1, 1 approved with reservations","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v1#referee-response-42876","order":0,"name":"referee-response-42876","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Pauline Frizelle<\/b>; \n<i>Posted: 05 Dec 2024<\/i>; We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each point.  A point of clarification - The reviewer notes that participants will be targeted for recruitment from 4 Community Healthcare Organizations (CHOs) based on level of social disadvantage using a deprivation index. Participants will be recruited from 8 &nbsp;Community Healthcare Organizations (4 each year). &nbsp;  Narrow the age range of participants.&nbsp; Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers.&nbsp;  \n<b>Response<\/b> - The reviewer notes that it is concerning that child participants span a very broad age range i.e. 0-6.&nbsp; For clarification, the overall Happy Talk programme provides services for children 0-6 years, but this evaluation is focussed on the preschool programme only, which ranges from 2;10 months to a maximum of 6 years. However the majority of children fall within the 3 \u2013 5 year age range.&nbsp; &nbsp; &nbsp;  Engage parents in developing their intervention.&nbsp; Check on their ability to attend 12 1-hour sessions. When in the&nbsp; course of the program will they be completed?&nbsp; There is no discussion about the 12 1-hour sessions.&nbsp; Are they in person?&nbsp; Online?&nbsp;  \n<b>Response<\/b> \u2013 This intervention has been implemented in one area of Ireland (to over 80 settings) for in excess of 11 years. The feasibility of the programme with parents living in socially disadvantaged areas has long been established.&nbsp;Feedback from parents and early years educators has been embedded in the programme since it was first developed. We realise that there will always be variability in parental attendance particularly when a programme is not yet established in an area. We had specified that the 12 1 hours sessions took place in 4 week blocks, 1 between September and December, 1 between January and March and 1 between April and June. We have clarified that they are in person. &nbsp;  Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly.&nbsp;Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers.&nbsp; Then changes in them could be considered mediators of change in the child outcomes.&nbsp; If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful.&nbsp; Note that the maternal responsiveness measure will be based on a videotape segment.&nbsp; Could the child's language in this segment be an outcome?  \n<b>Response: <\/b>In line with the reviewer and our logic model\/ theory of change, we consider both the parent and educator outcome measures as&nbsp; mediators of change in the child outcomes. In our pilot trial we were unable to show significant change in our parent group and did not have a sufficient number of settings to explore the impact of potential changes in the preschool environment. Despite this, the intervention had a large effect on the participating children. However, we will add an exploratory set of models to the statistical analysis plan aimed at evaluating heterogeneity in treatment effects on child outcomes as a function of parent and educator outcomes. In addition, parents and teachers will be completing their own separate fidelity checks and 20% of the intervention sessions will also be coded for fidelity against the manual. The videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to &nbsp;significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. &nbsp;  Secondary child outcomes are weak.&nbsp; They rely on parent reports and are not sensitive to advances, but rather child weaknesses.&nbsp; No educator ratings are planned.&nbsp; Why not use a functional measure, such as the Vineland.&nbsp; Alternatively, the investigators could code child language from the MRBC videos.  \n<b>Response:<\/b> We are capturing changes in child language through our primary outcomes measures, a standardized composite language measure (the PLS- 5) and a functional measure&nbsp; (the FOCUS- 34). Changes in parent behaviour are captured through the MRBCS, - an observation schedule shown to capture key characteristics associated with language growth over time (Down et al., 2015; Levickis et al., 2014; Smith et al., 2019) . The secondary outcome measures are as the reviewer suggests parent proxy measures, however literature suggests that parental measures are considered reliable and with acceptable concurrent validity (Feldman et al., 2005). The CLASS&nbsp; secondary outcome measure is a reliable measure which will allow us to assess change in the quality of interactions between teachers and students in the classroom, this is an aspect of our logic model which we deem important to capture.&nbsp; The Vineland is a measure of overall cognition rather than one that focuses specifically on language. We have not included educator ratings of children, as the staff working with children are not always consistent and they are working with large groups of children, only some of which are included in the evaluation. &nbsp;We do not want them to focus their attention\/prioritise&nbsp; those in the evaluation over and above those who are not.&nbsp; &nbsp; &nbsp;  Consider dropping the health-related quality-of-life measure as it has no relation to the intervention.  \n<b>Response<\/b> \u2013 We agree that the HRQL measures are not ideal and may not be&nbsp; sensitive to the changes that we expect as a result of our intervention, this was the case in our pilot trial. However, our pilot trial assessments took place over a short time period and it is not recommended to complete these measures over a period shorter than a year. Improvement in language outcomes are associated with overall well-being and these HRQL measures do ask about communication, which is at the core of our intervention. We do not have other measures at our disposal that can generate QALYs and are therefore suitable for a primary cost effectiveness analysis. &nbsp;&nbsp;  Rethink the economic analyses based on QALYs and HRQOL.&nbsp;  \n<b>Response<\/b> - We have given these measures considerable thought and in discussion with our health economist had decided to include them as they are not onerous to complete and there are currently no better alternatives. We have however also included the FOCUS \u2013 34 as our functional measure and the PLS-5 scores will be used in our secondary cost effectiveness analysis.&nbsp; Our pilot trial included a value of information analysis, and indicated that there was value in collecting further information in a large scale trial. &nbsp;  The randomization of sites scheme.&nbsp; The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2.&nbsp; Isn\u2019t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants?  \n<b>Response<\/b>- Round 2 will involve the recruitment of 4 additional sites (in different areas) and will have no relationship with the sites recruited&nbsp; in round 1.  Down, K., Levickis, P., Hudson, S., Nicholls, R. and Wake, M. (2015), Measuring maternal responsiveness. Child Care Health Dev, 41: 329-333.&nbsp;https:\/\/doi.org\/10.1111\/cch.12174  Feldman HM, Dale PS, Campbell TF, Colborn DK, Kurs-Lasky M, Rockette HE, Paradise JL. Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years. Child Dev. 2005 Jul-Aug;76(4):856-68. doi: 10.1111\/j.1467-8624.2005.00882.x. PMID: 16026501; PMCID: PMC1350485.  Levickis, Penny PhD\n<sup>*,\u2020,\u2021<\/sup>; Reilly, Sheena PhD\n<sup>*,\u2021<\/sup>; Girolametto, Luigi PhD\n<sup>&sect;<\/sup>; Ukoumunne, Obioha C. PhD\n<sup>\u2016<\/sup>; Wake, Melissa MD\n<sup>*,\u2020,\u2021<\/sup>.&nbsp;Maternal Behaviors Promoting Language Acquisition in Slow-to-Talk Toddlers: Prospective Community-based Study. Journal of Developmental &amp; Behavioral Pediatrics 35(4):p 274-281, May 2014. | DOI: 10.1097\/DBP.0000000000000056  Smith, J., Levickis, P., Eadie, T., Bretherton, L., Conway, L., &amp; Goldfeld, S. (2019). Associations between early maternal behaviours and child language at 36 months in a cohort experiencing adversity.&nbsp;\n<i>International journal of language &amp; communication disorders<\/i>,&nbsp;\n<i>54<\/i>(1), 110\u2013122. https:\/\/doi.org\/10.1111\/1460-6984.12435","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v3#referee-comment-3696","order":1,"name":"referee-comment-3696","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/hrbopenres.15422.r43949, Meredith L. Rowe, Harvard University, Cambridge, 06 Jan 2025, version 2, indexed","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v2#referee-response-43949","order":2,"name":"referee-response-43949","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Pauline Frizelle<\/b>; \n<i>Posted: 23 Jan 2025<\/i>; Many thanks for your valuable feedback - we have addressed each point in turn  Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale \n<b>Response:<\/b> The profile of all settings is that they are in significantly disadvantaged areas and are designated DEIS pre\/schools in Ireland (Delivering Equality and Opportunity in schools). We appreciate that there will be different degrees of disadvantage within a given setting, however, we will note these individual differences in the collection of our demographic data. We acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable.  Are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? \n<b>Response:<\/b> Parents are not compensated for attending the sessions, they opt in without additional incentives. In areas where Happy Talk is well established there is very high attendance as other parents\/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child\u2019s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme.  it might be important to see if the children in the classrooms of \u201ccommunication champions\u201d do better than those in other treatment classrooms \n<b>Response: <\/b>There will be a communication champion in all rooms in which there are children attending Happy Talk. We have clarified this in the text.\n<b> <\/b>  I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS.&nbsp; That is, if is it possible to audiotape a short \u201ccircle time\u201d session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc.&nbsp; This would be similar to the MRBCS but in the classroom context.&nbsp; This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects.&nbsp; -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language\/vocabulary.&nbsp; \n<b>Response: <\/b>We appreciate the reviewers comments with respect to capturing the day to day changes in child language and interaction. We are using the FOCUS-34 with the aim of capturing these functional changes at home and in school.\n<b> <\/b>Unfortunately time constraints and resources prevent us from recording and coding sessions in the classroom. There are also ethical issues as we would be actively recording children who have consented to receiving Happy Talk but have not consented to participate in the evaluation. We are cognisant of the burden of evaluation on families and for this reason, do not want to introduce any further outcome measures. We are reluctant to use the language produced during the MRBCS as a measure of child language \/vocabulary for the reasons outlined in response to reviewer 1. Specifically, the videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to &nbsp;significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability.   *these last two comments are based on the fact that many parent and preschool interventions have a hard time \u2018moving the needle\u2019 on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed.&nbsp; If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent\/teacher reporting).&nbsp;  I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up?&nbsp; If this is the case, this factor needs to be controlled\/examined or potentially manipulated in classroom placement for the children randomly chosen to participate.&nbsp; \n<b>Response: <\/b>All educators and children will only participate in the intervention for one year. However, it is possible that some children will progress from an intervention preschool to a school that also participated in the intervention and where the teacher was trained in the Happy Talk programme. We will control for this factor.\n<b> &nbsp;<\/b>","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v3#referee-comment-3720","order":3,"name":"referee-comment-3720","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/hrbopenres.15422.r43956, Nicola Botting, City University London, London, 08 Jan 2025, version 2, indexed","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v2#referee-response-43956","order":4,"name":"referee-response-43956","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Pauline Frizelle<\/b>; \n<i>Posted: 23 Jan 2025<\/i>; Thank you for taking the time to give your valuable feedback.  1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). \n<b>Response<\/b>: We have added the clarification to RQ1 - that the intervention is being compared to usual care  2. Recruitment: Opt-in consent is being used.&nbsp; It would be useful to identify and detail any strategies for monitoring\/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain.&nbsp; Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed.&nbsp; A small point but it is probably best to avoid the term 'subjects' even in a trial? \n<b>Response:<\/b> In relation to the profile of those who sign up, we appreciate that there will be variability in terms of levels of disadvantage. However, we will note these individual differences in the collection of our demographic data. As stated in response to another reviewer &nbsp;we acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. In addition to the initial information session, our consent process is being facilitated by the pre\/school staff who are available to read through the trial information and consent forms and answer any questions that potential participants might have when dropping and collecting their children. We appreciate the suggestion re Qualtrics but this would require access to a computer and feedback from pre\/school staff is that they prefer to support the process in an informal way so that parents don\u2019t feel under pressure to participate in the evaluation. There are large numbers of children receiving the intervention who are not part of the evaluation and if we were to engage in an opt out process, we would not have the capacity to assess them all in the restricted time frame. We have clarified that families are randomly selected from consenting families. As the reviewer rightly points out we are not actively assessing parents level of English and we have amended the text to remove the requirement of level B2. &nbsp;Parents will be asked if they are confident to complete the outcome measures without the need for an interpreter. We have replaced the term subjects, the use of which was an oversight on our part.  3. \n<b>Data management:<\/b>&nbsp; I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome.&nbsp; It would be useful to know who has overall responsibility for data governance and data backups etc. \n<b>Response:<\/b> This is a national study and therefore there is no data sharing between countries. We have made our data management plan available on OSF (https:\/\/osf.io\/ns7u5\/) to address the reviewers point.  4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only.&nbsp; How will you deal with participants who do not give consent to recording or to other people in the background? \n<b>Response: <\/b>The workshops are for the pre\/school staff and will be attended by the number who are participating in the intervention in a given pre\/school, this varies from setting to setting and goes beyond those who are included in the trial. For example in some preschools there may be 3 staff (working in one room) where as others may have 5 across two rooms.\n<b>&nbsp; <\/b>We have clarified this in the text.\n<b> <\/b> We have specified that we will audio record the sessions, the therapist will wear a microphone, set to capture his\/her input only. We appreciate that some child audio may be picked up in the distance but they will not be identifiable; we will not transcribe it (if audible); and we will not be using it in any way to measure interventionist fidelity.\n<b> <\/b>We have clarified that there will be 4 SLTs each year (8 in total) who will be attending the video-conference calls.&nbsp;  5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication?&nbsp; Will the reliability measures taken by an additional person occur at the same time or on a different day?&nbsp; In addition I wondered whether the FOCUS-34 has a reference?&nbsp; A couple of example questions might be useful here.&nbsp; For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'?&nbsp; If not, more explanation is needed. \n<b>Response:<\/b> We used the CsC in our pilot trial and although we were not able to complete statistical analyses (due to a small number of settings) our observations of the data suggested that it was not sensitive to the expected changes. Empirical literature suggests that the CLASS is a reliable tool across a number of languages (Hamre et al., 2008; Stuck et al., 2016; Virtanen et al., 2017) and we expect sensitivity to a number of areas in which we aim to effect change - in particular \n<i>Concept development, Quality of feedback <\/i>and \n<i>Language modelling<\/i>. In addition, colleagues who have significant experience researching in the area of professional development of early years educators, have found the CLASS to be a sensitive measure (Eadie et. al.,). Because the CLASS is completed live, reliability checking will involve score checking only. However, to be deemed a reliable coder, all CLASS administrators are required to score within 1 point of master codes on 80% of all codes given in the training videos. &nbsp; We have added some references for the FOCUS-34, as well as some sample questions. We have reworded in relation to the MRBCS.  6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. \n<b>Response: <\/b>We have adapted the text to make the secondary (economic) analysis more explicit, specifying these two measures.","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v3#referee-comment-3722","order":5,"name":"referee-comment-3722","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/hrbopenres.15422.r44222, Naja Ferjan Ramirez, Adeline Braverman, University of Washington, Seattle, 11 Jan 2025, version 2, indexed","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v2#referee-response-44222","order":6,"name":"referee-response-44222","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Pauline Frizelle<\/b>; \n<i>Posted: 23 Jan 2025<\/i>; Many thanks for your valuable feedback, we have addressed each point in turn.  \n<b>12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions \u2013 this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable\/executable given their day-to-day lives? Not much is said about this in the narrative.<\/b> \n<b>Response: <\/b>Happy Talk has been delivered in one part of Ireland for 12 years. The programme was originally developed by SLTs but the design has been adapted over the years based on feedback from parents and early years educators. &nbsp;We also measured feasibility and acceptability in a new area in our pilot trial (referenced within). As stated in response to reviewer 2, in areas where Happy Talk is well established there is very high attendance as other parents\/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child\u2019s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. In any case, we take a conservative approach in using an intention to treat protocol, so that if a parent attends even one session they are considered to have received the intervention.  \n<b>The second research question asks whether Happy Talk \u201cenhance[s] responsiveness and language-promoting behaviors in home and pre\/school contexts.\u201d The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to \u201clanguage-promoting behaviors\u201d beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question.<\/b> \n<b>Response:<\/b> We have clarified that responsiveness is the language-promoting behavior in question.   \n<b>Nothing is said about measuring \u201cattendance\u201d \u2013 i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance\/drop-out rates in previous iterations of the intervention?<\/b> \n<b>Response:<\/b> We have clarified that attendance will be measured throughout both iterations of the programme. As stated above, attendance tends to increase as parents become more engaged with the programme. We have reported the attendance rates and attrition in our published pilot trial.  \n<b>Inclusion of fathers: not much is said about this\u2026in our experience, if fathers are just \u201cinvited\u201d, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR \u2013 alternatively -&nbsp; if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment?<\/b> \n<b>Response:<\/b> Given the demands of the programme the reviewer has highlighted, we encourage one parent\/caregiver to attend, whichever places the smallest burden on the family. In our experience this is most often the mother but fathers and grandparents have also attended. If there are a sufficient number of cases where individual parents attend different sessions or both parents attend we will examine any potential effects statistically. However, this has not been our experience in the past. We request that the same person attend for baseline and end of programme measures.  \n<b>In the \u2018Data Collection\u2019 section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint?<\/b> \n<b>Response<\/b>: We have clarified that all outcome measures are included at the initial stages.  \n<b>How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded?<\/b> \n<b>Response:<\/b> No, these are not recorded. The 2\n<sup>nd<\/sup> researcher will check that the scores have been added correctly, and converted accurately into standard scores. We have clarified this in the text.  \n<b>Preschool staff treatment \u2013 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement.<\/b> \n<b>Response<\/b>: In keeping with my response with respect to parents, teachers have implemented the programme in one area of Ireland for many years, and have reported it to be feasible and acceptable \u2013 we have noted this in the text. They have also had input into the programme as it was developing over many years. We carry out the sessions in the classroom at a time that is convenient for the teachers. In addition, all teachers are required to engage with continuous professional development, the Happy Talk training fulfils that need.  \n<b>Child outcomes: most are parent\/staff reports, which is a disadvantage, given that they\u2019re being treated. One might hypothesize that the intervention will train the parents\/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention.<\/b> \n<b>Response<\/b>: We have included the PLS-5 which is a standardized language measure which provides a receptive, expressive and composite language score.  \n<b>In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box.<\/b> \n<b>Response: <\/b>Where arrows don\u2019t directly align they are intended to refer to more than one component within a given box, we have clarified this in the text.  \n<b>For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that\u2019s missing is the intervention \u201cscripts\u201d\/ content\/ manual \u2013 this is not shared, so one could not actually replicate the study as it is unclear what the parents \/ staff are actually told during the sessions. I am not sure if this is intentional.<\/b> \n<b>Response:<\/b> We cannot make the manual publicly available due to copyright reasons. Those who are interested in getting further information, or adapting the intervention to their context are welcome to get in touch with the first author.","URL":"https:\/\/hrbopenresearch.org\/articles\/7-65\/v3#referee-comment-3721","order":7,"name":"referee-comment-3721","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Health Research Board Ireland [DIFA 2023 001]. This work was also supported by the Irish Health Services Executive. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":8,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}