An implementation strategy bundle to improve home visit quality of the national child development program in Brazil: An implementation feasibility trial

An implementation strategy bundle to improve home visit quality of the national child development program in Brazil: An implementation feasibility trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article An implementation strategy bundle to improve home visit quality of the national child development program in Brazil: An implementation feasibility trial Alexandra Brentani, Christopher Westgard, Susan Chang-Lopez, Ana Carolina da Silva Onofre, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7768829/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background Programa Criança Feliz (PCF) is Brazil's home visitation program aimed at enhancing early childhood development. Evaluations of the program have found significant program challenges and implementation barriers, including the lack of a structured curriculum, insufficient training, and little supervisory support. This study tests the revised content of the home visits and new implementation strategies aimed at addressing these barriers and enhancing the quality of PCF home visits. Methods The implementation strategies were piloted across 8 diverse municipalities in an implementation feasibility trial. The new strategies were assessed using a one group pre-post analysis along with mixed methods to assess the extent to which they were acceptable, feasible, and associated with a change in home visit quality. A paired t-test and an independent t-test analysis were used to assess the change in home visit quality. The implementation outcomes were assessed with qualitative analysis and the Framework Method approach. Results The proposed home visitation guidelines, material, training, and supervision process were determined to be highly acceptable, feasible, and associated with improved quality of home visits. The home visit quality scores significantly increased by 14.68 points (SD = 14.89, CI 95%: 7.27–22.08, p = 0.0006), according to the paired t-test. The study participants provide insightful suggestions for adaptations that can occur before testing the strategies more broadly. Conclusion The study underscores the importance of tailoring implementation strategies to address specific barriers for home visitation programs. The positive response to the modified curriculum, training methods, and supervision indicates potential for broader application, both within Brazil and in similar programs globally. Home visit quality public policy implementation at scale feasibility and acceptability Figures Figure 1 Figure 2 Contributions to the literature 1. Modular, choice-constrained curriculum reduces planning burden and improves visit structure. Home visitors reported that the activity compendium and step-by-step guidelines made planning and delivery easier and faster, shifting time from planning to interaction; supervisors and HVs described clearer sequencing. 2. Routine “recap” of prior activities increases caregiver engagement and carryover at home. HVs described families sharing progress once recap became standard. 3. Simulation-based training (demonstrations/role-play) builds capability more effectively than didactic training alone. Participants emphasized the value of hands-on demonstrations; supervisors received a parallel module. 4. Lightweight, structured supervision with simple observation tools narrows variation. Supervisors found the instruments easy to use; post-test variance decreased, indicating harmonization of practice. 5. Low-resource, adaptable materials facilitate delivery in constrained settings. The curriculum reduces toy/material needs and offers multiple activity options per age band, supporting feasibility across diverse contexts. Background The first five years of a child's life are characterized by rapid growth and adaptation, with the brain being highly plastic and capable of enhancing specific capacities and abilities. 1 – 3 Interventions that support early childhood development (ECD) in children have been shown to have long-term benefits including higher adult wages, 4,5 better educational attainment, 6 improved health biomarkers, 7 reductions in violence, 8 and physical growth in the subsequent generations. 9 Teaching caregivers how to effectively care for and stimulate the development of their children is an important strategy to improve early childhood development outcomes. 10 , 11 Programs that conduct home visits to improve caregiver knowledge and parenting practices have shown success at improving child development. 10 , 12 – 17 Although using home visits to improve child development shows great promise, they often fail to produce the expected outcomes when scaled. The reach, quality, and equity of the programs are often inadequate for underserved-populations. 18 Large-scale programs need close monitoring and continuous improvement of the implementation process to strengthen the quality of the program. 26 , 27 Efforts to improve the quality of home visitation programs have led to large benefits in terms of quality and impact. 28 – 30 Following the principles described in the MERLA cycle (monitoring, evaluation, research, learning, and adaptation cycle), after monitoring the program for barriers to program implementation, the implementation process should be adapted to address the barriers. 31 , 32 Once the adaptations have been identified, they should be tested in the field to ensure they are feasible and show promise of being effective. 33 – Programa Criança Feliz (PCF) of Brazil is the largest home visitation program to support child development in the world. 40 The program aims to improve ECD in the country’s most vulnerable populations. 41 It trains and supports paraprofessionals to conduct home visits with caregivers of children under 3 years (or under 6 years if the child has a disability) from vulnerable communities. The home visitors (HVs) are expected to support the caregivers, promote ECD and guide families on how to access other government social services. Recent evaluations of PCF have identified multiple barriers to effective implementation. 41 , 42 A primary barrier that was highlighted was the quality and usability of broad guidelines for home visits. Home visitors expressed a lack of standardized protocols and material for home visits. 42 Challenges are exacerbated by weaknesses in the training process and supervision the HVs receive. There is a need for research to be conducted on PCF to improve its overall effectiveness. The objective of the current study is to test the acceptability and feasibility of a new implementation strategy bundle and to test the influence they have on the quality of home visits by PCF. The study will help to determine if the new implementation strategies created observable changes in the quality of home visits and to identify how the strategies can be adapted to further improve fit with local context. Methodos The Implementation Strategies For this study, a new implementation strategy bundle was developed to address previously identified barriers related to home visit quality. One key barrier highlighted in previous studies was a need to improve the guidance and material for HVs. 41–43 Another barrier was the lack of supervision and feedback received by supervisors to ensure the quality of home visits. 42 To address these barriers, a research team at the Medical School of the Universidade de São Paulo and the Reach Up programme from, The University of the West Indies, Jamaica with years of collective learning about the program and with the support of the Lego Foundation, developed an adaptable approach to enhance the quality of home visits through more age-appropriate and culturally suitable guidelines and material. The approach is based on the Reach Up Early Childhood Parenting Program and curriculum 44 , adapted to provide more choice for HV’s in activities used and reduced quantity of toys and materials needed for the visits and is more conducive to large-scale implementation in diverse contexts. The revised curriculum includes a set of age-appropriate activities (the activities compendium) from which activities are selected, home visit guidelines, a supervisory protocol, and monitoring forms. The team also adapted the Reach Up training protocols to teach the HVs how to effectively conduct home visits with the new content. The training session included 40 hours of in-person or online training for the HVs. The supervisors and managers in the participating municipalities received the same training, plus an additional 8-hour training module on supervision and monitoring. Training was conducted by trained members of the research team with previous training in the Reach Up programme. More details of the home visit curriculum, training methodology, and supervisory protocol are described in Appendix 1. The current study assessed the use of the adapted program curriculum in PCF. Study location and participants The municipalities that participated in the study were selected by the research team in collaboration with a committee of representatives from PCF to represent the diversity of the program beneficiaries. The municipalities were selected in the 4 regions of the country where PCF is primarily implemented – The north, northeast, southeast, and central-west – and included rural and urban communities, indigenous, quilombola (African-Brazilian), and riverside populations. The strategy bundle was implemented and tested in two stages. The first stage was conducted to test the implementation outcomes of acceptability and feasibility, while collecting information on suggested adaptations of the strategy bundle. Stage one included the municipalities (Municipality, State): 1. Água Branca, Alagoas, 2. Tocantinia, Tocantins, 3. Ilha Comprida, São Paulo, and 4. Una, Bahia. Training for this group took place from July-August of 2022. A total of 28 HVs, 4 supervisors, and 2 managers received training in the use of the strategies and then used the new methodology for 2 months before evaluation. Semi-structured key informant interviews (KIIs) were conducted with 7 caregivers and 4 supervisors, and 8 focus group discussions (FGDs) were conducted with 32 staff members (28 HVs and 4 supervisors). Two FGDs were conducted in each municipality, one FGD to discuss the training and HV methodology and the other FGD to discuss the list of activities for the HVs (activities compendium). The second stage was conducted to test the influence the implementation strategies had on the quality of home visits. Stage two included the municipalities (Municipality, State): 1. Oriximiná, Pará 2. Jordão, Acre 3. Petrópolis, Rio de Janeiro and 4. Camaçari, Bahia. Training for this second group comprising 53 HVs, took place in August – September of 2022. Before the training began, independent assessors observed and scored the quality of the home visits. The quality of home visits was assessed again after 3 months of implementation by the same assessors. There were 18 HVs that were present for both the pre-test and post-test. The other 35 HVs were present for only the pre-test or post-test, due to high staff turnover. Study design The current study is an implementation feasibility trial to test the implementation strategy bundle. An implementation feasibility trial is an effective method to test the influence of new implementation strategies on implementation and service outcomes. 33,34,45 The primary outcome of the study is the quality of home visits by the HVs of PCF, which reflects the effectiveness of the implementation strategies to improve HV performance. 47 Improved quality of home visits is expected to lead to improvements in caregiver knowledge and ultimately child development outcomes, following extended exposure. 29,48,49 The secondary outcomes are the acceptability and feasibility of the new strategy and recommendations for adaptations, measured and analyzed with qualitative methods. The study trial uses a pre-post test study design to assess the influence of the bundle on home visit quality. 34,50 The study includes one group, comprising those who received the new bundle. All HVs in the participating communities participated in the training. Since the trial was implemented the group of beneficiaries enrolled in the Criança Feliz program, no exclusion criteria were considered. Sample size calculation The sample size calculation for the quantitative assessment is based on a previous study that used the same home visit quality scale, and reported a mean baseline HV score of 59 points with a standard deviation of 11. 56 The improved home visiting content and training were hypothesized to improve home visit quality scores by 1 SD. Additional parameters are set at 0.05 for the alpha error (two-tailed), and study power of .08. The sample size calculation indicated a desired sample size of 16 HVs. The study anticipated a loss of follow-up of 30%, therefore the minimal sample size was set at 25 HVs. The sample size is deemed adequate based on standards of implementation feasibility pilots described in the literature and used by similar studies. 33–35,50,57,58 The sample size for the qualitative assessment was determined based on an estimated point of thematic saturation and data adequacy. 60 Based on previous qualitative studies of home visit material, it was projected that two FGDs per municipality would provide data adequacy. 29,61 The FGDs were complemented by individual KIIs in each municipality. Home Visit Quality Instrument To evaluate the quality of home visits by the HVs, independent researchers were trained to use the Home Visit Quality Check list (The Check List). The Checklist was a modified version of the Reach Up Observation checklist, updated based on lessons learned from the field and a consultation exercise with a team of experts. 56 The Reach Up Observation Checklist was developed to be a simple and easily administered tool for program supervisors to monitor quality of home visits and support home visitors. It was developed to be simpler, yet comparably effective to the Home Visit Rating Scales (HOVRS-3), the gold standard in the field. 56,63 The Reach Up Observation Checklist has high internal consistency (𝛼 = .81–.86) and high concurrent validity with the HOVRS. The adapted version of the checklist used for this study contains 54 items divided into five sections: Review of the Last Visit, Activities and Methodologies, Caregiver Relationship, Child Relationship, General Vision of Visit. The items are scored on a Likert-scale of 1-5 or a binary variable of “yes” or “no”. Data collection occurred in July 2021, two weeks before the staff training (July and August 2021) after 3 months of the new methodology implementation (November and December 2021). For both timepoints, data was collected simultaneously in the municipalities. Implementation Outcomes Instrument The interview guide to assess the implementation outcomes included questions regarding the acceptability of the new program content, the feasibility of implementing/using the new protocols, and what suggestions participants have for adaptations. The interview guide was used for the FGDs and KIIs. The interview guide included 9 open-ended questions related to the home visit content, training, and supervisory protocol. Questions were included to probe information regarding the acceptability, feasibility, and adaptations of each component of the implementation strategy bundle. The interview guide was developed by the research team, utilizing the concepts of implementation outcomes described by Proctor, et., al., 2011. 47 The interview guide was piloted with a small group of HVs to identify opportunities to clarify the questions. Research Ethics and Consent to Participate The current study received ethical approval from the PI’s Institution, under protocol number CAAE 51767121.1.0000.0068. All participants provided written informed consent following a complete description of the study, before participating in the study. All transcripts and interview results were without any identifiable information. All participants received an explanation of the study’s purpose and interview procedures. If the participant agreed to participate in the study by giving written consent, then they began the interview. Data analysis and interpretation - Home Visit Quality The home visit quality scores were assessed in two ways: 1) a descriptive analysis of scores before and after implementation, and 2) a t-test analysis to compare pre- and post-scores to determine if a change in home visit quality occurred following the use of the new implementation strategies. The descriptive analysis of pre- and post-implementation scores helped to determine the strengths and weaknesses of the home visits with or without the new content and the variance of quality scores were used to determine how the scores compared before and after the introduction of new implementation strategies. The descriptive analysis provided mean scores, standard deviation, and differences. The paired t-test was conducted with the sample of HVs that were scored in both the pre-test and post-test. The independent t-test was conducted with the sample of HVs that were present only for the pre- or post-test. Both the paired and independent t-tests were two-tailed with an alpha level of 0.05. Data analysis and interpretation – Acceptability, Feasibility, and Adaptations The implementation outcomes were assessed with qualitative analysis methods and the Framework Method approach, including a deductive and thematic content analysis approach. 51 The approach is used to draw descriptive and explanatory conclusions clustered around themes. It includes the creation of a matrix output to summarize data, providing a structure for the researchers to systematically synthesize the data by case and by code. 52 A codebook was created before the analysis began based on the research objectives and implementation outcomes being studied. Each implementation outcome was matched with a component of the implementation strategy bundle (see Box 1 below). Box 1 – Codes used to summarize data in the qualitative analysis Matrix Codebook “Acceptability of home visit methodology” “Feasibility of home visit methodology” “Adaptations to home visit methodology” “Acceptability of training module” “Feasibility of training modules” “Adaptations to training modules” All interviews and focus groups were conducted in person by the PI and 4 other members of the research team with experience in qualitative research (AB, ALC, LB, CO and NP). The interviews and focus groups used an open-ended semi-structured questionnaire, created by the research team. The interviews were recorded and transcribed by four members of the research team. The transcriptions were coded by two members of the research team that are trained in qualitative analysis (CMW and AB). They independently coded the same two KII transcripts and two FGD and then came together to discuss the codes they applied. After consistency between the two coders was reached, one researcher coded the rest of the transcripts (AB). When this process was complete, the coded quotations were extracted from NVIVO 53 and organized in a results matrix in Excel. The quotes were categorized by implementation outcomes (acceptability, feasibility, and adaptation) and by strategy-type (home visitation content, training, and supervision) (see Box1). The results matrix was then reviewed by two members of the research team that are experts in home visitation programs and familiar with PCF and the local context (CMW and AB). The researchers collaboratively analyzed the matrix, synthesized the information, and highlighted the most important quotes to be presented in the study. The implementation outcomes used were based on the categorization of outcomes by Proctor, et., al., 2011. 47 For the current study, acceptability is defined as the perception that the intervention is agreeable, palatable, or satisfactory. 47 The analysis of the information pertaining to acceptability reports if the participants find the implementation strategy bundle sufficiently satisfactory to accept as the new practice standard. Feasibility is the extent to which the new strategies can be successfully used within the local setting. 47,54 The analysis of feasibility reports on how the implementation strategies were used in the local setting, to determine if their use was feasible. Adaptation is a process of thoughtful and deliberate alteration to the design or delivery of an intervention, with the goal of improving its fit or effectiveness in a given context. 55 The analysis of adaptation reports on any suggestions for adaptations to the bundle or intervention that were provided by study participants. Results Quality of home Visits The quality of home visit scores for all HVs, at pre-test and post-test, along with results from the paired t-test and independent t-test analysis are shown in Table 1. Quality of home visit scores were collected from 53 home visitors, 18 of which are paired samples (at pre- and post-test) and 35 are independent samples (11 present at only pre-test and 24 present at only post-test). In the paired t-test analysis the scores improved by 14.68 (SD=14.89, CI 95%: 7.27 – 22.08, p=0.0006). In the independent t-test analysis the scores differed by 23.16, (SD=13.65, CI 95%: 16.99 – 29.33). Of the five sub-domains from the scale, four showed significant improvements, including: review of the last visit, activities and methodologies, caregiver relationship, and child relationship (shown in Table 1). The changes in sub-domain scores from pre-test to post-test are shown in Figure 1. The standard deviation was greater in the pre-test scores than the post-test scores, representing decreased variance following the implementation of the new implementation strategies, as shown in Figure 2. Table 1. Home Visit Quality Scores Figure 1. Home Visit Quality Sub-domain scores, pre- and post-test Figure 2. Home Visit Quality Scores, with Variance, Pre-test – Post-test Implementation Outcomes: Home Visitation Content The complete set of quotes that were extracted from the transcripts can be seen in the Appendix 2. Acceptability of the new home visitation content (guidelines, material, activities compendium) was high for all study participants. The most frequently reported advantage of the new content was the ease of selecting activities to conduct during the home visit. A home visitor said, “This method helped us because we used to have a lot of difficulty choosing the activity, which used to be more complicated because each different activity had to be specific. And today, with this method, it's easier? It allows the user to have access to many activities, so it's even quicker for us to make our plan and go for a visit” Several study participants commented that the new content was highly acceptable because it provided clear guidelines and a standardized structured process to execute the home visits. A home visitor said, “[The home visit guidelines] was very different because we brought something already structured. You know there was a beginning, middle, and end. So it was a very innovative experience, both for the family and for us.” The feasibility of implementing the new home visitation content was primarily expressed by how it was used and if any problems arose. The study participants described the home visitation content as feasible to implement and highlighted how specific components of the curriculum were used. For example, the task of recapping activities from previous home visits. A home visitor said, “Regarding the recap of previous activities, some families began sending me videos of how the child performed, of how they progressed. Engagement improved after we started recapping.” Adaptations of the home visitation content were suggested by some study participants. However, most participants did not have suggestions for how it could be adapted. Study participants commented that the activities’ compendium could be improved, specifically on the ability to adjust activities to the child’s ability. A home visitor said, “as for the activities, they are great, but there are some mothers who, when we arrive, they say that the activity is delayed, because the child already does those things.” A supervisor pointed out that it would be helpful if the description of the activities included images. Another supervisor commented that the music singing suggestion of the home visits was not well received. Implementation Outcomes: Training Protocol The acceptability of the training protocol was high, overall. The study participants expressed appreciation for the changes they experienced in training, in comparison to the previous training methodology. The interactive dynamic of the new training protocol was well accepted by the supervisors and home visitors. Several participants commented that the training provided an important opportunity to improve their knowledge of their work. The most frequently expressed sentiment regarding the training was that it helped the HVs understand the tasks and structure of the home visits. A home visitor said, “[The training] helped us better understand each step of the home visit, the before, during, and after.” The portion of the training that included demonstrations of home visits and simulations (role play) conducting home visits was described as acceptable and feasible. A home visitor said, “we've been here for three years, right? And we never had training like this, demonstrative, with theater and everything, no, there wasn't.” Feasibility of the training protocol was determined to be high. There were no comments by the study participants that indicated that the training protocol, or any of its parts, were not feasible to implement. Some study participants pointed out that the length of the training could be reduced because it was difficult for interns to participate in the training. A supervisor said, “There is the question of timing. Not everyone can stay all day because of completion of internship hours, and that complicated the participation a little. Adaptations of the training protocol were suggested by some study participants. A study participant suggested that there was too much repetition in the training activities, suggesting this could be reduced. Another adaptation that was suggested was to include information about traditional communities in the training. Most study participants commented that no adaptations were needed to the training protocol. Implementation Outcomes: Supervisory System The new supervisory system that was implemented to improve quality assurance for home visits was deemed acceptable by the supervisors that participated in the study. Several noted that the new supervision protocol is important to provide quality service to families. Several also noted that the new supervisory system was helpful because of the new forms and procedures that were provided to conduct supervisory visits with the HVs. The new procedures enable monitoring of the home visits to ensure consistent quality. A supervisor said, “the evaluation of activities by the supervisor, the actual supervisory part, the instruments, I believe are quite simple, and they help when observing home visits.” Discussion The current research shows that the new implementation strategies were well accepted and feasible to implement in the local context. The strategies were also associated with an improvement in the quality of home visits. Providing HVs with a curriculum that allowed selection from sets of age-appropriate activities, clear guidelines, as well as effective training and supervision, enhanced the programs’ ability to promote early childhood development in underserved populations. Our study results align with existing literature that indicates that structured home visitation guidelines and ease of selecting age-appropriate activities for the home visits are key factors for enhancing program effectiveness. Effective programs provide structured, yet flexible curricula to meet the needs of the families. 16,66 This was reflected by the improvements in the quality of home visits seen in this study after providing improved home visitation content. The suggestions for adaptations to the home visitation content provided important feedback on how the strategies can be further improved before implementing and testing more broadly. The suggestion to provide enough activities to consistently engage children across multiple visits and the possibility of adjusting these activities not only to their specific developmental levels, but also to the culture and context have been noted as essential to maximizing the impact of home visits. 67 The HV’s expressed that the improved training protocol helped them better understand how to deliver the home visits and gave them more confidence in doing so. Effective training has been shown to enhance the competence of HVs, which also enhances their self-efficacy and job satisfaction. 16 The training protocol can potentially be further improved by addressing the HVs suggestion of limiting the repetition of some training activities and the overall time of the training, while ensuring the quality of the training was maintained. Effective supervision is an essential element of home visitation programs for ensuring quality and fidelity. 69 Standardized supervision helps maintain consistent program activities and quality, across diverse settings and over time. 69 The supervisory system introduced in this study was well received by program participants, citing their appreciation for standardized guidelines and instruments. Previous research has shown that the use of structured monitoring tools to assess fidelity in home visitation programs enhances the supervision process and can lead to better implementation outcomes. 16,70,71 Previous studies called for further mixed-methods implementation research to investigate the feasibility and effectiveness of implementation strategies to improve quality, fidelity, and sustainability of PCF. 42 This research answered that call. The strategy bundle was purpose-built for scale: modular activity sets with constrained choice, simulation-based training for enactment, and brief supervisory tools for routine observation and feedback. Tested across diverse municipalities and populations, these strategies demonstrated feasibility and mechanism-linked improvements in home-visit quality, alongside reduced variance. Because they minimize material requirements and codify simple work processes, they are readily portable to other national HV systems facing similar barriers. We therefore offer the bundle not only as a proof of concept for PCF, but as a set of generalizable design principles for improving HV implementation quality in resource-constrained settings. Design Principles for HV Quality Improvement 1. Heterogeneous test bed: Piloting across multiple municipalities spanning several Brazilian regions, including urban, rural, indigenous, quilombola, and riverside populations. Intentionally sampled variation to test transportability rather than fit to a single locale. 2. Scalable design constraints: Strategies rely on low-cost materials, modular content, and brief supervisory tools, features common to resource-constrained HV systems globally. 3. Replicable delivery package: We specify the HV training and supervisor module, the observation checklist, and the supervisory workflow; appendices contain operational details that are readily reusable. 4. Validated measurement and multi-method inference: We used a standardized visit-quality observation checklist and triangulated quantitative gains with qualitative mechanism evidence, supporting why quality improved, not only that it improved. 5. Consistency signals: Post-implementation variance decreased alongside mean gains, consistent with scalable supervision effects that other programs can expect when adopting similar tools. 6. Platform for scale: Because PCF is a large national program, demonstrating feasibility and mechanism-linked quality gains here informs other national systems facing analogous barriers. Limitations of study The study's design imposes limitations. Firstly, the pre-post design with no control group precludes being able to determine whether the observed changes to the quality of home visits are due to the implementation bundle or other external factors. Furthermore, the brief interval between the intervention delivery and the subsequent assessments might not adequately capture any decline in knowledge and performance over time. The study used purposeful sampling to ensure diversity of respondents within a small sample size and thus may differ from the broader population of HVs in ways that are unforeseen. Therefore, the study is limited in its ability to conclude that the findings are generalizable. We therefore encourage the replication of our study in a larger and more rigorous study design. Despite some limitations, we fulfilled the standards for an implementation feasibility trial so the findings can be used to inform a larger trial. Conclusion The implementation feasibility trial reported here shows that the implementation strategies developed to address barriers related to home visitation content and plans, training, and supervision were acceptable, feasible, and associated with improved quality of home visits. The HVs and supervisors in the study most appreciated the ease of selecting the age-appropriate activities and clear guidelines for the home visits, the training’s ability to make the HVs feel prepared to create positive interactions with caregivers, and the supervisor system providing a standardized procedure and improved monitoring instruments. Declarations Ethics approval and consent to participate : The current study received ethical approval from the PI’s Institutional IRB, University of São Paulo Medical School Hospital- HC-FMUSP (CAPPESQ) under protocol number CAAE 51767121.1.0000.0068. All participants provided written informed consent following a complete description of the study, before participating in the study. All transcripts and interview results were without any identifiable information. Consent for publication : not applicable Availability of data and materials : The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Competing interests : The authors declare that they have no competing interests Funding: The study was funded by the LEGO Foundation and the Conselho Nacional de Ciência e Tecnologia (CNPq) grant Nº 315984/2021-0. The funders had no participation in study design, analysis or result’s interpretation. Authors' contributions : AB, CMW, ACSO, NP, LB, ALRC, JLS, DFSC, contributed to the design and implementation of the study, revised and approved the manuscript. ACSO, NP, LB, ALRC, and DFSC conducted the interviews. CMW, ALRC, and AB conducted the analysis and accessed and verified the data reported in the manuscript. SCL, JH, HP, and SW advised on study design and revised the manuscript. CMW and AB wrote manuscript. AB supervised the Project and received the funding. Acknowledgements : The authors would like to acknowledge the support of the Ministry of Social Development and the Municipalities involved in the study, as well as the staff members and families who contributed to the study. References Huttenlocher PR. Neural Plasticity: The Effects of Environment on the Development of the Cerebral Cortex. Harvard University Press; 2002:274. Britto PR, Pérez-Escamilla R. No second chances? Early critical periods in human development. Introduction. 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Evaluating Fidelity in Home-Visiting Programs a Qualitative Analysis of 1058 Home Visit Case Notes from 105 Families. PLOS ONE. 2012;7(5):e36915. doi:10.1371/journal.pone.0036915 Roben CKP, Costello AH, Friedman JM, Wright C, Dozier M. Prioritizing fidelity within public policies supporting evidence-based home visiting. Transl Issues Psychol Sci. 2021;7(1):35-45. doi:10.1037/tps0000234 Table Table 1. Home Visit Quality Scores Pre-Test Average Post-Test Average Difference T-test p-value All home visitors 39.39 (N=29, SD=12.79) 57.99 (N=42, SD=6.49) 18.6 - Paired t-test analysis 43.77 (N=18, SD=32.76) 58.45 (N=18, SD=5.28) 14.68 p=0.0006 Independent T-test analysis 33.89 (N=11, SD=10.09) 57.05, (N=24, SD=7.43) 23.16 p=0.0000 Sub-domains (paired t-test) Review of the Last Visit 1.72 4.57 2.85 p=0.0002* Activities and Methodologies 8.92 13.71 4.79 p<0.0000* Caregiver Relationship 12.27 14.52 2.26 p=0.0065* Child Relationship 10.62 14.23 3.62 p=0.0028* General Vision of Visit 10 11.04 1.04 p=0.2545 Supplementary Files Appendix1.DescriptionofIntervention.docx Appendix2.QuotesandCodes.xlsx CONSORTextensionPilotandFeasibilityTrialsChecklist.doc Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 19 Nov, 2025 Reviewers invited by journal 19 Nov, 2025 Editor assigned by journal 24 Oct, 2025 First submitted to journal 23 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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08:54:59","extension":"html","order_by":19,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":169196,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/49874df3053b3aca001b3d43.html"},{"id":96979497,"identity":"c04d7c6e-70e0-40f7-a69e-1b1e14272595","added_by":"auto","created_at":"2025-11-28 08:54:56","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":98645,"visible":true,"origin":"","legend":"\u003cp\u003eHome Visit Quality Sub-domain scores, pre- and post-test\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/a3bf42c380364eee0e354647.png"},{"id":96979516,"identity":"59a6b3c8-e64e-4894-984a-bafef148e4a5","added_by":"auto","created_at":"2025-11-28 08:55:05","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":56761,"visible":true,"origin":"","legend":"\u003cp\u003eHome Visit Quality Scores, with Variance, Pre-test – Post-test\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/4516187192a7ed19d4d527b6.png"},{"id":97144618,"identity":"423fd364-98f3-4343-9d8f-f19d10787f38","added_by":"auto","created_at":"2025-12-01 10:11:29","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":791709,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/7e913a44-4fed-408a-af5e-1af9e02f9823.pdf"},{"id":97138601,"identity":"a2d08380-a5cc-4aae-954f-a03a0ec9b4cd","added_by":"auto","created_at":"2025-12-01 09:59:07","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":17810,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1.DescriptionofIntervention.docx","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/fbe96b1acf462e052b828ca1.docx"},{"id":97138705,"identity":"2c68fc67-50be-41e0-bae3-b7f77f9ee112","added_by":"auto","created_at":"2025-12-01 09:59:13","extension":"xlsx","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":42095,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix2.QuotesandCodes.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/76638844e51b7a2afae19047.xlsx"},{"id":96979505,"identity":"c49d1c52-88a7-41d7-a305-4d4245c5baca","added_by":"auto","created_at":"2025-11-28 08:54:57","extension":"doc","order_by":7,"title":"","display":"","copyAsset":false,"role":"supplement","size":235008,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORTextensionPilotandFeasibilityTrialsChecklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-7768829/v1/14f58c3af1f5c64e0b38af18.doc"}],"financialInterests":"","formattedTitle":"An implementation strategy bundle to improve home visit quality of the national child development program in Brazil: An implementation feasibility trial","fulltext":[{"header":"Contributions to the literature","content":"\u003cp\u003e1. Modular, choice-constrained curriculum reduces planning burden and improves visit structure. Home visitors reported that the activity compendium and step-by-step guidelines made planning and delivery easier and faster, shifting time from planning to interaction; supervisors and HVs described clearer sequencing.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;2. Routine \u0026ldquo;recap\u0026rdquo; of prior activities increases caregiver engagement and carryover at home. HVs described families sharing progress once recap became standard.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;3. Simulation-based training (demonstrations/role-play) builds capability more effectively than didactic training alone. Participants emphasized the value of hands-on demonstrations; supervisors received a parallel module.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;4. Lightweight, structured supervision with simple observation tools narrows variation. Supervisors found the instruments easy to use; post-test variance decreased, indicating harmonization of practice.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;5. Low-resource, adaptable materials facilitate delivery in constrained settings. The curriculum reduces toy/material needs and offers multiple activity options per age band, supporting feasibility across diverse contexts.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003eThe first five years of a child's life are characterized by rapid growth and adaptation, with the brain being highly plastic and capable of enhancing specific capacities and abilities.\u003csup\u003e\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e Interventions that support early childhood development (ECD) in children have been shown to have long-term benefits including higher adult wages,\u003csup\u003e4,5\u003c/sup\u003e better educational attainment,\u003csup\u003e6\u003c/sup\u003e improved health biomarkers,\u003csup\u003e7\u003c/sup\u003e reductions in violence,\u003csup\u003e8\u003c/sup\u003e and physical growth in the subsequent generations.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e Teaching caregivers how to effectively care for and stimulate the development of their children is an important strategy to improve early childhood development outcomes.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e Programs that conduct home visits to improve caregiver knowledge and parenting practices have shown success at improving child development.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan additionalcitationids=\"CR13 CR14 CR15 CR16\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eAlthough using home visits to improve child development shows great promise, they often fail to produce the expected outcomes when scaled. The reach, quality, and equity of the programs are often inadequate for underserved-populations.\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e Large-scale programs need close monitoring and continuous improvement of the implementation process to strengthen the quality of the program.\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e,\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e Efforts to improve the quality of home visitation programs have led to large benefits in terms of quality and impact.\u003csup\u003e\u003cspan additionalcitationids=\"CR29\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e Following the principles described in the MERLA cycle (monitoring, evaluation, research, learning, and adaptation cycle), after monitoring the program for barriers to program implementation, the implementation process should be adapted to address the barriers.\u003csup\u003e\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e,\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e Once the adaptations have been identified, they should be tested in the field to ensure they are feasible and show promise of being effective.\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u0026ndash;\u003c/sup\u003e\u003c/p\u003e\u003cp\u003ePrograma Crian\u0026ccedil;a Feliz (PCF) of Brazil is the largest home visitation program to support child development in the world.\u003csup\u003e\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e The program aims to improve ECD in the country\u0026rsquo;s most vulnerable populations.\u003csup\u003e\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e It trains and supports paraprofessionals to conduct home visits with caregivers of children under 3 years (or under 6 years if the child has a disability) from vulnerable communities. The home visitors (HVs) are expected to support the caregivers, promote ECD and guide families on how to access other government social services. Recent evaluations of PCF have identified multiple barriers to effective implementation.\u003csup\u003e\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e,\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e A primary barrier that was highlighted was the quality and usability of broad guidelines for home visits. Home visitors expressed a lack of standardized protocols and material for home visits.\u003csup\u003e\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e Challenges are exacerbated by weaknesses in the training process and supervision the HVs receive.\u003c/p\u003e\u003cp\u003eThere is a need for research to be conducted on PCF to improve its overall effectiveness. The objective of the current study is to test the acceptability and feasibility of a new implementation strategy bundle and to test the influence they have on the quality of home visits by PCF. The study will help to determine if the new implementation strategies created observable changes in the quality of home visits and to identify how the strategies can be adapted to further improve fit with local context.\u003c/p\u003e"},{"header":"Methodos","content":"\u003cp\u003e\u003cem\u003eThe Implementation Strategies\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFor this study, a new implementation strategy bundle was developed to address previously identified barriers related to home visit quality. One key barrier highlighted in previous studies was a need to improve the guidance and material for HVs.\u003csup\u003e41\u0026ndash;43\u003c/sup\u003e Another barrier was the lack of supervision and feedback received by supervisors to ensure the quality of home visits.\u003csup\u003e42\u003c/sup\u003e To address these barriers, a research team at the Medical School of the Universidade de S\u0026atilde;o Paulo and the Reach Up programme from, The University of the West Indies, Jamaica with years of collective learning about the program and with the support of the Lego Foundation, developed an adaptable approach to enhance the quality of home visits through \u0026nbsp;more age-appropriate and culturally suitable guidelines and material. The approach is based on the Reach Up Early Childhood Parenting Program and curriculum\u003csup\u003e44\u003c/sup\u003e, adapted to provide more choice for HV\u0026rsquo;s in activities used and reduced quantity of toys and materials needed for the visits and is more conducive to large-scale implementation in diverse contexts. The revised curriculum includes a set of age-appropriate activities (the activities compendium) from which activities are selected, home visit guidelines, a supervisory protocol, and monitoring forms. The team also adapted the Reach Up training protocols to teach the HVs how to effectively conduct home visits with the new content. The training session included 40 hours of in-person or online training for the HVs. The supervisors and managers in the participating municipalities received the same training, plus an additional 8-hour training module on supervision and monitoring. Training was conducted by trained members of the research team with previous training in the Reach Up programme. More details of the home visit curriculum, training methodology, and supervisory protocol are described in Appendix 1. The current study assessed the use of the adapted program curriculum in PCF.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy location and participants\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe municipalities that participated in the study were selected by the research team in collaboration with a committee of representatives from PCF to represent the diversity of the program beneficiaries. The municipalities were selected in the 4 regions of the country where PCF is primarily implemented \u0026ndash; The north, northeast, southeast, and central-west \u0026ndash; and included rural and urban communities, indigenous, quilombola (African-Brazilian), and riverside populations.\u003c/p\u003e\n\u003cp\u003eThe strategy bundle was implemented and tested in two stages. The first stage was conducted to test the implementation outcomes of acceptability and feasibility, while collecting information on suggested adaptations of the strategy bundle. Stage one included the municipalities (Municipality, State): 1. \u0026Aacute;gua Branca, Alagoas, 2. Tocantinia, Tocantins, 3. Ilha Comprida, S\u0026atilde;o Paulo, and 4. Una, Bahia. Training for this group took place from July-August of 2022. A total of 28 HVs, 4 supervisors, and 2 managers received training in the use of the strategies and then used the new methodology for 2 months before evaluation. Semi-structured key informant interviews (KIIs) were conducted with 7 caregivers and 4 supervisors, and 8 focus group discussions (FGDs) were conducted with 32 staff members (28 HVs and 4 supervisors). Two FGDs were conducted in each municipality, one FGD to discuss the training and HV methodology and the other FGD to discuss the list of activities for the HVs (activities compendium).\u003c/p\u003e\n\u003cp\u003eThe second stage was conducted to test the influence the implementation strategies had on the quality of home visits. Stage two included the municipalities (Municipality, State): 1. Oriximin\u0026aacute;, Par\u0026aacute; 2. Jord\u0026atilde;o, Acre 3. Petr\u0026oacute;polis, Rio de Janeiro and 4. Cama\u0026ccedil;ari, Bahia. Training for this second group comprising 53 HVs, took place in August \u0026ndash; September of 2022. Before the training began, independent assessors observed and scored the quality of the home visits. \u0026nbsp;The quality of home visits was assessed again after 3 months of implementation by the same assessors. There were 18 HVs that were present for both the pre-test and post-test. The other 35 HVs were present for only the pre-test or post-test, due to high staff turnover.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy design\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe current study is an implementation feasibility trial to test the implementation strategy bundle. An implementation feasibility trial is an effective method to test the influence of new implementation strategies on implementation and service outcomes.\u003csup\u003e33,34,45\u003c/sup\u003e The primary outcome of the study is the quality of home visits by the HVs of PCF, which reflects the effectiveness of the implementation strategies to improve HV performance.\u003csup\u003e47\u003c/sup\u003e Improved quality of home visits is expected to lead to improvements in caregiver knowledge and ultimately child development outcomes, following extended exposure.\u003csup\u003e29,48,49\u003c/sup\u003e The secondary outcomes are the acceptability and feasibility of the new strategy and recommendations for adaptations, measured and analyzed with qualitative methods.\u003c/p\u003e\n\u003cp\u003eThe study trial uses a pre-post test study design to assess the influence of the bundle on home visit quality.\u003csup\u003e34,50\u003c/sup\u003e The study includes one group, comprising those who received the new bundle. All HVs in the participating communities participated in the training. Since the trial was implemented the group of beneficiaries enrolled in the Crian\u0026ccedil;a Feliz program, no exclusion criteria were considered.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSample size calculation\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size calculation for the quantitative assessment is based on a previous study that used the same home visit quality scale, and reported a mean baseline HV score of 59 points with a standard deviation of 11.\u003csup\u003e56\u003c/sup\u003e The improved home visiting content and training were hypothesized to improve home visit quality scores by 1 SD. Additional parameters are set at 0.05 for the alpha error (two-tailed), and study power of .08. The sample size calculation indicated a desired sample size of 16 HVs. The study anticipated a loss of follow-up of 30%, therefore the minimal sample size was set at 25 HVs. The sample size is deemed adequate based on standards of implementation feasibility pilots described in the literature and used by similar studies.\u003csup\u003e33\u0026ndash;35,50,57,58\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe sample size for the qualitative assessment was determined based on an estimated point of thematic saturation and data adequacy.\u003csup\u003e60\u003c/sup\u003e Based on previous qualitative studies of home visit material, it was projected that two FGDs per municipality would provide data adequacy.\u003csup\u003e29,61\u003c/sup\u003e The FGDs were complemented by individual KIIs in each municipality.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eHome Visit Quality Instrument\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTo evaluate the quality of home visits by the HVs, independent researchers were trained to use the Home Visit Quality Check list (The Check List). The Checklist was a modified version of the Reach Up Observation checklist, updated based on lessons learned from the field and a consultation exercise with a team of experts.\u003csup\u003e56\u003c/sup\u003e The Reach Up Observation Checklist was developed to be a simple and easily administered tool for program supervisors to monitor quality of home visits and support home visitors. It was developed to be simpler, yet comparably effective to the Home Visit Rating Scales (HOVRS-3), the gold standard in the field.\u003csup\u003e56,63\u003c/sup\u003e The Reach Up Observation Checklist has high internal consistency (𝛼 = .81\u0026ndash;.86) and high concurrent validity with the HOVRS. The adapted version of the checklist used for this study contains 54 items divided into five sections: Review of the Last Visit, Activities and Methodologies, Caregiver Relationship, Child Relationship, General Vision of Visit. The items are scored on a Likert-scale of 1-5 or a binary variable of \u0026ldquo;yes\u0026rdquo; or \u0026ldquo;no\u0026rdquo;. Data collection occurred in July 2021, two weeks before the staff training (July and August 2021) after 3 months of the new methodology implementation (November and December 2021). For both timepoints, data was collected simultaneously in the municipalities.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eImplementation Outcomes Instrument\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe interview guide to assess the implementation outcomes included questions regarding the acceptability of the new program content, the feasibility of implementing/using the new protocols, and what suggestions participants have for adaptations. The interview guide was used for the FGDs and KIIs. The interview guide included 9 open-ended questions related to the home visit content, training, and supervisory protocol. Questions were included to probe information regarding the acceptability, feasibility, and adaptations of each component of the implementation strategy bundle. The interview guide was developed by the research team, utilizing the concepts of implementation outcomes described by Proctor, et., al., 2011.\u003csup\u003e47\u003c/sup\u003e The interview guide was piloted with a small group of HVs to identify opportunities to clarify the questions.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResearch Ethics and Consent to Participate\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe current study received ethical approval from the PI\u0026rsquo;s Institution, under protocol number CAAE 51767121.1.0000.0068. All participants provided written informed consent following a complete description of the study, before participating in the study. All transcripts and interview results were without any identifiable information.\u003c/p\u003e\n\u003cp\u003eAll participants received an explanation of the study\u0026rsquo;s purpose and interview procedures. If the participant agreed to participate in the study by giving written consent, then they began the interview.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eData analysis and interpretation - Home Visit Quality\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe home visit quality scores were assessed in two ways: 1) a descriptive analysis of scores before and after implementation, and 2) a t-test analysis to compare pre- and post-scores to determine if a change in home visit quality occurred following the use of the new implementation strategies. The descriptive analysis of pre- and post-implementation scores helped to determine the strengths and weaknesses of the home visits with or without the new content and the variance of quality scores were used to determine how the scores compared before and after the introduction of new implementation strategies. The descriptive analysis provided mean scores, standard deviation, and differences. The paired t-test was conducted with the sample of HVs that were scored in both the pre-test and post-test. The independent t-test was conducted with the sample of HVs that were present only for the pre- or post-test. Both the paired and independent t-tests were two-tailed with an alpha level of 0.05.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eData analysis and interpretation \u0026ndash; Acceptability, Feasibility, and Adaptations\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe implementation outcomes were assessed with qualitative analysis methods and the Framework Method approach, including a deductive and thematic content analysis approach.\u003csup\u003e51\u003c/sup\u003e The approach is used to draw descriptive and explanatory conclusions clustered around themes. It includes the creation of a matrix output to summarize data, providing a structure for the researchers to systematically synthesize the data by case and by code.\u003csup\u003e52\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA codebook was created before the analysis began based on the research objectives and implementation outcomes being studied. Each implementation outcome was matched with a component of the implementation strategy bundle (see Box 1 below).\u003c/p\u003e\n\u003cp\u003eBox 1 \u0026ndash; Codes used to summarize data in the qualitative analysis\u003c/p\u003e\n\u003ctable style=\"width: 100%;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 100.0000%;\"\u003e\n \u003cp\u003eMatrix Codebook\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026ldquo;Acceptability of home visit methodology\u0026rdquo;\u003c/p\u003e\n \u003cp\u003e\u0026ldquo;Feasibility of home visit methodology\u0026rdquo;\u003c/p\u003e\n \u003cp\u003e\u0026ldquo;Adaptations to home visit methodology\u0026rdquo;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026ldquo;Acceptability of training module\u0026rdquo;\u003c/p\u003e\n \u003cp\u003e\u0026ldquo;Feasibility of training modules\u0026rdquo;\u003c/p\u003e\n \u003cp\u003e\u0026ldquo;Adaptations to training modules\u0026rdquo;\u003c/p\u003e\u003cbr\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAll interviews and focus groups were conducted in person by the PI and 4 other members of the research team with experience in qualitative research (AB, ALC, LB, CO and NP). The interviews and focus groups used an open-ended semi-structured questionnaire, created by the research team. The interviews were recorded and transcribed by four members of the research team. The transcriptions were coded by two members of the research team that are trained in qualitative analysis (CMW and AB). They independently coded the same two KII transcripts and two FGD and then came together to discuss the codes they applied. After consistency between the two coders was reached, one researcher coded the rest of the transcripts (AB). When this process was complete, the coded quotations were extracted from NVIVO\u003csup\u003e53\u003c/sup\u003e and organized in a results matrix in Excel. The quotes were categorized by implementation outcomes (acceptability, feasibility, and adaptation) and by strategy-type (home visitation content, training, and supervision) (see Box1). The results matrix was then reviewed by two members of the research team that are experts in home visitation programs and familiar with PCF and the local context (CMW and AB). The researchers collaboratively analyzed the matrix, synthesized the information, and highlighted the most important quotes to be presented in the study.\u003c/p\u003e\n\u003cp\u003eThe implementation outcomes used were based on the categorization of outcomes by Proctor, et., al., 2011.\u003csup\u003e\u0026nbsp;47\u003c/sup\u003e For the current study, acceptability is defined as the perception that the intervention is agreeable, palatable, or satisfactory.\u003csup\u003e47\u003c/sup\u003e The analysis of the information pertaining to acceptability reports if the participants find the implementation strategy bundle sufficiently satisfactory to accept as the new practice standard. Feasibility is the extent to which the new strategies can be successfully used within the local setting.\u003csup\u003e47,54\u003c/sup\u003e The analysis of feasibility reports on how the implementation strategies were used in the local setting, to determine if their use was feasible. Adaptation is a process of thoughtful and deliberate alteration to the design or delivery of an intervention, with the goal of improving its fit or effectiveness in a given context.\u003csup\u003e55\u003c/sup\u003e The analysis of adaptation reports on any suggestions for adaptations to the bundle or intervention that were provided by study participants.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cem\u003eQuality of home Visits\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe quality of home visit scores for all HVs, at pre-test and post-test, along with results from the paired t-test and independent t-test analysis are shown in Table 1. Quality of home visit scores were collected from 53 home visitors, 18 of which are paired samples (at pre- and post-test) and 35 are independent samples (11 present at only pre-test and 24 present at only post-test). In the paired t-test analysis the scores improved by 14.68 (SD=14.89, CI 95%: 7.27 \u0026ndash; 22.08, p=0.0006). In the independent t-test analysis the scores differed by 23.16, (SD=13.65, CI 95%: 16.99 \u0026ndash; 29.33). Of the five sub-domains from the scale, four showed significant improvements, including: review of the last visit, activities and methodologies, caregiver relationship, and child relationship (shown in Table 1). The changes in sub-domain scores from pre-test to post-test are shown in Figure 1. The standard deviation was greater in the pre-test scores than the post-test scores, representing decreased variance following the implementation of the new implementation strategies, as shown in Figure 2.\u003c/p\u003e\n\u003cp\u003eTable 1. Home Visit Quality Scores\u003c/p\u003e\n\u003cp\u003eFigure 1. Home Visit Quality Sub-domain scores, pre- and post-test\u003c/p\u003e\n\u003cp\u003eFigure 2. Home Visit Quality Scores, with Variance, Pre-test \u0026ndash; Post-test\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eImplementation Outcomes: Home Visitation Content\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe complete set of quotes that were extracted from the transcripts can be seen in the Appendix 2. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAcceptability of the new home visitation content (guidelines, material, activities compendium) was high for all study participants. The most frequently reported advantage of the new content was the ease of selecting activities to conduct during the home visit.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eA home visitor said, \u0026ldquo;This method helped us because we used to have a lot of difficulty choosing the activity, which used to be more complicated because each different activity had to be specific. And today, with this method, it\u0026apos;s easier? It allows the user to have access to many activities, so it\u0026apos;s even quicker for us to make our plan and go for a visit\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSeveral study participants commented that the new content was highly acceptable because it provided clear guidelines and a standardized structured process to execute the home visits.\u003c/p\u003e\n\u003cp\u003eA home visitor said, \u003cem\u003e\u0026ldquo;[The home visit guidelines] was very different because we brought something already structured. You know there was a beginning, middle, and end. So it was a very innovative experience, both for the family and for us.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe feasibility of implementing the new home visitation content was primarily expressed by how it was used and if any problems arose. The study participants described the home visitation content as feasible to implement and highlighted how specific components of the curriculum were used. For example, the task of recapping activities from previous home visits.\u003c/p\u003e\n\u003cp\u003eA home visitor said, \u003cem\u003e\u0026ldquo;Regarding the recap of previous activities, some families began sending me videos of how the child performed, of how they progressed. Engagement improved after we started recapping.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAdaptations of the home visitation content were suggested by some study participants. However, most participants did not have suggestions for how it could be adapted. Study participants commented that the activities\u0026rsquo; compendium could be improved, specifically on the ability to adjust activities to the child\u0026rsquo;s ability.\u003c/p\u003e\n\u003cp\u003eA home visitor said, \u003cem\u003e\u0026ldquo;as for the activities, they are great, but there are some mothers who, when we arrive, they say that the activity is delayed, because the child already does those things.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA supervisor pointed out that it would be helpful if the description of the activities included images. Another supervisor commented that the music singing suggestion of the home visits was not well received.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eImplementation Outcomes: Training Protocol\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe acceptability of the training protocol was high, overall. The study participants expressed appreciation for the changes they experienced in training, in comparison to the previous training methodology. The interactive dynamic of the new training protocol was well accepted by the supervisors and home visitors. Several participants commented that the training provided an important opportunity to improve their knowledge of their work. The most frequently expressed sentiment regarding the training was that it helped the HVs understand the tasks and structure of the home visits.\u003c/p\u003e\n\u003cp\u003eA home visitor said, \u003cem\u003e\u0026ldquo;[The training] helped us better understand each step of the home visit, the before, during, and after.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe portion of the training that included demonstrations of home visits and simulations (role play) conducting home visits was described as acceptable and feasible.\u003c/p\u003e\n\u003cp\u003eA home visitor said, \u003cem\u003e\u0026ldquo;we\u0026apos;ve been here for three years, right? And we never had training like this, demonstrative, with theater and everything, no, there wasn\u0026apos;t.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFeasibility of the training protocol was determined to be high. There were no comments by the study participants that indicated that the training protocol, or any of its parts, were not feasible to implement. Some study participants pointed out that the length of the training could be reduced because it was difficult for interns to participate in the training. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA supervisor said, \u003cem\u003e\u0026ldquo;There is the question of timing. Not everyone can stay all day because of completion of internship hours, and that complicated the participation a little.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAdaptations of the training protocol were suggested by some study participants. A study participant suggested that there was too much repetition in the training activities, suggesting this could be reduced. Another adaptation that was suggested was to include information about traditional communities in the training. Most study participants commented that no adaptations were needed to the training protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eImplementation Outcomes: Supervisory System\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe new supervisory system that was implemented to improve quality assurance for home visits was deemed acceptable by the supervisors that participated in the study. Several noted that the new supervision protocol is important to provide quality service to families. Several also noted that the new supervisory system was helpful because of the new forms and procedures that were provided to conduct supervisory visits with the HVs. The new procedures enable monitoring of the home visits to ensure consistent quality.\u003c/p\u003e\n\u003cp\u003eA supervisor said, \u003cem\u003e\u0026ldquo;the evaluation of activities by the supervisor, the actual supervisory part, the instruments, I believe are quite simple, and they help when observing home visits.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe current research shows that the new implementation strategies were well accepted and feasible to implement in the local context. The strategies were also associated with an improvement in the quality of home visits. Providing HVs with a curriculum that allowed selection from sets of age-appropriate activities, clear guidelines, as well as effective training and supervision, enhanced the programs\u0026rsquo; ability to promote early childhood development in underserved populations.\u003c/p\u003e\n\u003cp\u003eOur study results align with existing literature that indicates that structured home visitation guidelines and ease of selecting age-appropriate activities for the home visits are key factors for enhancing program effectiveness. Effective programs provide structured, yet flexible curricula to meet the needs of the families.\u003csup\u003e16,66\u003c/sup\u003e This was reflected by the improvements in the quality of home visits seen in this study after providing improved home visitation content. The suggestions for adaptations to the home visitation content provided important feedback on how the strategies can be further improved before implementing and testing more broadly. The suggestion to provide enough activities to consistently engage children across multiple visits and the possibility of adjusting these activities not only to their specific developmental levels, but also to the culture and context have been noted as essential to maximizing the impact of home visits.\u003csup\u003e67\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe HV\u0026rsquo;s expressed that the improved training protocol helped them better understand how to deliver the home visits and gave them more confidence in doing so. Effective training has been shown to enhance the competence of HVs, which also enhances their self-efficacy and job satisfaction.\u003csup\u003e16\u003c/sup\u003e The training protocol can potentially be further improved by addressing the HVs suggestion of limiting the repetition of some training activities and the overall time of the training, while ensuring the quality of the training was maintained.\u003c/p\u003e\n\u003cp\u003eEffective supervision is an essential element of home visitation programs for ensuring quality and fidelity.\u003csup\u003e69\u003c/sup\u003e Standardized supervision helps maintain consistent program activities and quality, across diverse settings and over time.\u003csup\u003e69\u003c/sup\u003e The supervisory system introduced in this study was well received by program participants, citing their appreciation for standardized guidelines and instruments. Previous research has shown that the use of structured monitoring tools to assess fidelity in home visitation programs enhances the supervision process and can lead to better implementation outcomes.\u003csup\u003e16,70,71\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003ePrevious studies called for further mixed-methods implementation research to investigate the feasibility and effectiveness of implementation strategies to improve quality, fidelity, and sustainability of PCF.\u003csup\u003e42\u003c/sup\u003e This research answered that call.\u003c/p\u003e\n\u003cp\u003eThe strategy bundle was purpose-built for scale: modular activity sets with constrained choice, simulation-based training for enactment, and brief supervisory tools for routine observation and feedback. Tested across diverse municipalities and populations, these strategies demonstrated feasibility and mechanism-linked improvements in home-visit quality, alongside reduced variance. Because they minimize material requirements and codify simple work processes, they are readily portable to other national HV systems facing similar barriers. We therefore offer the bundle not only as a proof of concept for PCF, but as a set of generalizable design principles for improving HV implementation quality in resource-constrained settings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDesign Principles for HV Quality Improvement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Heterogeneous test bed: Piloting across multiple municipalities spanning several Brazilian regions, including urban, rural, indigenous, quilombola, and riverside populations. Intentionally sampled variation to test transportability rather than fit to a single locale.\u003c/p\u003e\n\u003cp\u003e2. Scalable design constraints: Strategies rely on low-cost materials, modular content, and brief supervisory tools, features common to resource-constrained HV systems globally.\u003c/p\u003e\n\u003cp\u003e3. Replicable delivery package: We specify the HV training and supervisor module, the observation checklist, and the supervisory workflow; appendices contain operational details that are readily reusable.\u003c/p\u003e\n\u003cp\u003e4. Validated measurement and multi-method inference: We used a standardized visit-quality observation checklist and triangulated quantitative gains with qualitative mechanism evidence, supporting why quality improved, not only that it improved.\u003c/p\u003e\n\u003cp\u003e5. Consistency signals: Post-implementation variance decreased alongside mean gains, consistent with scalable supervision effects that other programs can expect when adopting similar tools.\u003c/p\u003e\n\u003cp\u003e6. Platform for scale: Because PCF is a large national program, demonstrating feasibility and mechanism-linked quality gains here informs other national systems facing analogous barriers.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLimitations of study\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study\u0026apos;s design imposes limitations. Firstly, the pre-post design with no control group precludes being able to determine whether the observed changes to the quality of home visits are due to the implementation bundle or other external factors. Furthermore, the brief interval between the intervention delivery and the subsequent assessments might not adequately capture any decline in knowledge and performance over time. The study used purposeful sampling to ensure diversity of respondents within a small sample size and thus may differ from the broader population of HVs in ways that are unforeseen. Therefore, the study is limited in its ability to conclude that the findings are generalizable. We therefore encourage the replication of our study in a larger and more rigorous study design. Despite some limitations, we fulfilled the standards for an implementation feasibility trial so the findings can be used to inform a larger trial.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe implementation feasibility trial reported here shows that the implementation strategies developed to address barriers related to home visitation content and plans, training, and supervision were acceptable, feasible, and associated with improved quality of home visits. The HVs and supervisors in the study most appreciated the ease of selecting the age-appropriate activities and clear guidelines for the home visits, the training\u0026rsquo;s ability to make the HVs feel prepared to create positive interactions with caregivers, and the supervisor system providing a standardized procedure and improved monitoring instruments.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e: The current study received ethical approval from the PI\u0026rsquo;s Institutional IRB, University of S\u0026atilde;o Paulo Medical School Hospital- HC-FMUSP (CAPPESQ) under protocol number CAAE 51767121.1.0000.0068. All participants provided written informed consent following a complete description of the study, before participating in the study. All transcripts and interview results were without any identifiable information.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e: The authors declare that they have no competing interests\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e The study was funded by the LEGO Foundation and the Conselho Nacional de Ci\u0026ecirc;ncia e Tecnologia (CNPq) grant N\u0026ordm; 315984/2021-0. The funders had no participation in study design, analysis or result\u0026rsquo;s interpretation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e: AB, CMW, ACSO, NP, LB, ALRC, JLS, DFSC, contributed to the design and implementation of the study, revised and approved the manuscript. ACSO, NP, LB, ALRC, and DFSC conducted the interviews. CMW, ALRC, and AB conducted the analysis and accessed and verified the data reported in the manuscript. SCL, JH, HP, and SW advised on study design and revised the manuscript. CMW and AB wrote manuscript. AB supervised the Project and received the funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e: The authors would like to acknowledge the support of the Ministry of Social Development and the Municipalities involved in the study, as well as the staff members and families who contributed to the study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHuttenlocher PR. Neural Plasticity: The Effects of Environment on the Development of the Cerebral Cortex. Harvard University Press; 2002:274.\u003c/li\u003e\n\u003cli\u003eBritto PR, P\u0026eacute;rez-Escamilla R. No second chances? Early critical periods in human development. Introduction. Soc Sci Med 1982. 2013;97:238-240. doi:10.1016/j.socscimed.2013.09.001\u003c/li\u003e\n\u003cli\u003eKolb B, Whishaw IQ. Fundamentals of Human Neuropsychology. 5th ed. Worth Publishers; 2003. 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Accessed January 6, 2023. https://eric.ed.gov/?id=ED519240\u003c/li\u003e\n\u003cli\u003eMilner KM, Bhopal S, Black M, et al. Counting outcomes, coverage and quality for early child development programmes. Arch Dis Child. 2019;104(Suppl 1):S13-S21. doi:10.1136/archdischild-2018-315430\u003c/li\u003e\n\u003cli\u003eBernal R, G\u0026oacute;mez ML, P\u0026eacute;rez-Cardona S, Baker-Henningham H. Implementation Quality of an Early Childhood Parenting Program in Colombia and Child Development. Pediatrics. 2023;151(Supplement 2):e2023060221J. doi:10.1542/peds.2023-060221J\u003c/li\u003e\n\u003cli\u003eWestgard CM, Orrego-Ferreyros LA. An mHealth tool for community health workers to improve caregiver knowledge of child health in the Amazon: An effectiveness-implementation hybrid evaluation. PLOS Glob Public Health. 2022;2(9):e0001118. doi:10.1371/journal.pgph.0001118\u003c/li\u003e\n\u003cli\u003eWang L, Jiang D, Zhang S, Rozelle S. Caregivers\u0026rsquo; parenting beliefs, practices, and child developmental outcomes: Evidence from randomized controlled trials in rural China. World Dev. 2024;178:106596. doi:10.1016/j.worlddev.2024.106596\u003c/li\u003e\n\u003cli\u003eSubramanian S, Naimoli J, Matsubayashi T, Peters DH. Do we have the right models for scaling up health services to achieve the Millennium Development Goals? BMC Health Serv Res. 2011;11(1):336. doi:10.1186/1472-6963-11-336\u003c/li\u003e\n\u003cli\u003eYamey G. Scaling Up Global Health Interventions: A Proposed Framework for Success. PLOS Med. 2011;8(6):e1001049. doi:10.1371/journal.pmed.1001049\u003c/li\u003e\n\u003cli\u003ePearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020;6(1):167. doi:10.1186/s40814-020-00634-w\u003c/li\u003e\n\u003cli\u003eEldridge SM, Lancaster GA, Campbell MJ, et al. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PloS One. 2016;11(3):e0150205. doi:10.1371/journal.pone.0150205\u003c/li\u003e\n\u003cli\u003eHull L, Goulding L, Khadjesari Z, et al. Designing high-quality implementation research: development, application, feasibility and preliminary evaluation of the implementation science research development (ImpRes) tool and guide. Implement Sci. 2019;14(1):80. doi:10.1186/s13012-019-0897-z\u003c/li\u003e\n\u003cli\u003eWestgard C, Fleming WO. The Use of Implementation Science Tools to Design, Implement, and Monitor a Community-Based mHealth Intervention for Child Health in the Amazon. Front Public Health. 2020;8:411. doi:10.3389/fpubh.2020.00411\u003c/li\u003e\n\u003cli\u003eWestgard CM, Rivadeneyra N, Mechael P. mHealth tool to improve community health agent performance for child development: study protocol for a cluster-randomised controlled trial in Peru. BMJ Open. 2019;9(11):e028361. doi:10.1136/bmjopen-2018-028361\u003c/li\u003e\n\u003cli\u003eCavallera V, Tomlinson M, Radner J, et al. Scaling early child development: what are the barriers and enablers? Arch Dis Child. 2019;104(Suppl 1):S43-S50. doi:10.1136/archdischild-2018-315425\u003c/li\u003e\n\u003cli\u003eBarrera M, Berkel C, Castro FG. Directions for the Advancement of Culturally Adapted Preventive Interventions: Local Adaptations, Engagement, and Sustainability. Prev Sci. 2017;18(6):640-648. doi:10.1007/s11121-016-0705-9\u003c/li\u003e\n\u003cli\u003eCrianca Feliz: Brazil\u0026rsquo;s Ambitious Early Childhood Program. Harvard Kennedy School https://case.hks.harvard.edu/crianca-feliz-brazils-ambitious-early-childhood-program/\u003c/li\u003e\n\u003cli\u003eSantos IS, Munhoz TN, Barcelos RS, et al. Evaluation of the Happy Child Program: a randomized study in 30 Brazilian municipalities. Cienc Saude Coletiva. 2022;27(12):4341-4363. doi:10.1590/1413-812320222712.13472022\u003c/li\u003e\n\u003cli\u003eBuccini G, Gubert MB, Palmeira P de A, et al. Scaling up a home-visiting program for child development in Brazil: a comparative case studies analysis. Lancet Reg Health \u0026ndash; Am. 2024;29. doi:10.1016/j.lana.2023.100665\u003c/li\u003e\n\u003cli\u003eCruzado de la Vega V, Cavero Arguedas D, Araujo MC, Dormal M, Rubio-Codina M. Resultados de La Evaluacion de Impacto Del Servicio de Acompa\u0026ntilde;amiento a Familias Del Programa Nacional Cuna Mas. Ministerio de Economia y Finanzas, Intermericano de Desarrollo; 2016. https://www.mef.gob.pe/contenidos/presu_publ/ppr/eval_indep/informe_resultados_cuna_mas.pdf\u003c/li\u003e\n\u003cli\u003eHome. Reach Up and Learn. Accessed January 13, 2023. https://reachupandlearn.com/\u003c/li\u003e\n\u003cli\u003eOka M. Review of Feasibility Studies to Ensure Conducting the Proper Nursing Intervention Research. doi:10.23937/2469-5823/1510153\u003c/li\u003e\n\u003cli\u003eCurran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation Hybrid Designs. Med Care. 2012;50(3):217-226. doi:10.1097/MLR.0b013e3182408812\u003c/li\u003e\n\u003cli\u003eProctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65-76. doi:10.1007/s10488-010-0319-7\u003c/li\u003e\n\u003cli\u003eMorrison AK, Glick A, Yin HS. Health Literacy: Implications for Child Health. Pediatr Rev. 2019;40(6):263-277. doi:10.1542/pir.2018-0027\u003c/li\u003e\n\u003cli\u003eBrito LC dos S, Borges JWP, Pacheco HSA, et al. Knowledge of caregivers and factors associated with neuropsychomotor development in children. Rev Bras Enferm. 2021;75. doi:10.1590/0034-7167-2021-0402\u003c/li\u003e\n\u003cli\u003eAschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022;8(1):217. doi:10.1186/s40814-022-01178-x\u003c/li\u003e\n\u003cli\u003eGale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(1):117. doi:10.1186/1471-2288-13-117\u003c/li\u003e\n\u003cli\u003eRitchie J, Lewis J, Lewis P of SPJ, Nicholls CM, Ormston R. Qualitative Research Practice: A Guide for Social Science Students and Researchers. SAGE; 2013.\u003c/li\u003e\n\u003cli\u003eQualitative Data Analysis Software | NVivo. Accessed May 7, 2021. https://www.qsrinternational.com/nvivo-qualitative-data-analysis-software/home\u003c/li\u003e\n\u003cli\u003eKarsh BT. Beyond usability: designing effective technology implementation systems to promote patient safety. Qual Saf Health Care. 2004;13(5):388-394. doi:10.1136/qhc.13.5.388\u003c/li\u003e\n\u003cli\u003eWiltsey Stirman S, A Gutner C, Crits-Christoph P, Edmunds J, Evans AC, Beidas RS. Relationships between clinician-level attributes and fidelity-consistent and fidelity-inconsistent modifications to an evidence-based psychotherapy. Implement Sci. 2015;10(1):115. doi:10.1186/s13012-015-0308-z\u003c/li\u003e\n\u003cli\u003eRubio-Codina M, Dormal M, Araujo MC. Observing home-visiting quality at scale with the home visit rating scales and a supervisor checklist in Peru. Infant Ment Health J. 2019;40(3):343-362. doi:10.1002/imhj.21775\u003c/li\u003e\n\u003cli\u003eSit HF, Hong IW, Burchert S, et al. A Feasibility Study of the WHO Digital Mental Health Intervention Step-by-Step to Address Depression Among Chinese Young Adults. Front Psychiatry. 2022;12. Accessed July 14, 2023. https://www.frontiersin.org/articles/10.3389/fpsyt.2021.812667\u003c/li\u003e\n\u003cli\u003eServer A, Suso-Ribera C, P\u0026eacute;rez-Carrasco M, et al. Feasibility of a brief mindfulness-based program for burnout in pain healthcare professionals. Front Psychol. 2022;13. Accessed July 14, 2023. https://www.frontiersin.org/articles/10.3389/fpsyg.2022.1009266\u003c/li\u003e\n\u003cli\u003eEldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2(1):64. doi:10.1186/s40814-016-0105-8\u003c/li\u003e\n\u003cli\u003eVasileiou K, Barnett J, Thorpe S, Young T. Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period. BMC Med Res Methodol. 2018;18(1):148. doi:10.1186/s12874-018-0594-7\u003c/li\u003e\n\u003cli\u003eSmith JA, Baker-Henningham H, Brentani A, Mugweni R, Walker SP. Implementation of Reach Up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Ann N Y Acad Sci. 2018;1419(1):120-140. doi:10.1111/nyas.13678\u003c/li\u003e\n\u003cli\u003eSaunders B, Sim J, Kingstone T, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi:10.1007/s11135-017-0574-8\u003c/li\u003e\n\u003cli\u003eRoggman LA, Cook GA, Innocenti MS, et al. The Home Visit Rating Scales: Revised, restructured, and revalidated. Infant Ment Health J. 2019;40(3):315-330. doi:10.1002/imhj.21781\u003c/li\u003e\n\u003cli\u003eKendrick D, Elkan R, Hewitt M, et al. Does home visiting improve parenting and the quality of the home environment? A systematic review and meta analysis. Arch Dis Child. 2000;82(6):443-451. doi:10.1136/adc.82.6.443\u003c/li\u003e\n\u003cli\u003ePeterson CA, Hughes-Belding K, Rowe N, et al. Triadic Interactions in MIECHV: Relations to Home Visit Quality. Matern Child Health J. 2018;22(1):3-12. doi:10.1007/s10995-018-2534-x\u003c/li\u003e\n\u003cli\u003eBilukha O, Hahn R, Crosby A, et al. The effectiveness of early childhood home visitation in preventing violence: a systematic review. Am J Prev Med. 2005;28 2 Suppl 1:11-39. doi:10.1016/J.AMEPRE.2004.10.004\u003c/li\u003e\n\u003cli\u003eCasillas KL, Fauchier A, Derkash BT, Garrido EF. Implementation of evidence-based home visiting programs aimed at reducing child maltreatment: A meta-analytic review. Child Abuse Negl. 2016;53:64-80. doi:10.1016/j.chiabu.2015.10.009\u003c/li\u003e\n\u003cli\u003eOlds DL. Can Home Visitation Improve the Health of Women and Children at Environmental Risk? In: Improving The Life Chances Of Children At Risk. Routledge; 1990.\u003c/li\u003e\n\u003cli\u003eZolnoski S, Stacks AM, Kohl-Hanlon A, Dykehouse TA. Lessons Learned From the First-Year Evaluation of a Small-Scale Home Visitation Program. J Soc Serv Res. 2012;38(4):515-528. doi:10.1080/01488376.2012.699407\u003c/li\u003e\n\u003cli\u003eSa\u0026iuml;as T, Lerner E, Greacen T, et al. Evaluating Fidelity in Home-Visiting Programs a Qualitative Analysis of 1058 Home Visit Case Notes from 105 Families. PLOS ONE. 2012;7(5):e36915. doi:10.1371/journal.pone.0036915\u003c/li\u003e\n\u003cli\u003eRoben CKP, Costello AH, Friedman JM, Wright C, Dozier M. Prioritizing fidelity within public policies supporting evidence-based home visiting. Transl Issues Psychol Sci. 2021;7(1):35-45. doi:10.1037/tps0000234\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table","content":"\u003cp\u003eTable 1. Home Visit Quality Scores\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"629\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003ePre-Test Average\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003ePost-Test Average\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003eDifference\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003eT-test p-value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eAll home visitors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e39.39 (N=29, SD=12.79)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e57.99 (N=42, SD=6.49)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e18.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003ePaired t-test analysis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e43.77 (N=18, SD=32.76)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e58.45 (N=18, SD=5.28)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e14.68\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep=0.0006\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eIndependent T-test analysis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e33.89 (N=11, SD=10.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e57.05, (N=24, SD=7.43)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e23.16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep=0.0000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eSub-domains (paired t-test)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eReview of the Last Visit\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e1.72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e4.57\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e2.85\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep=0.0002*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eActivities and Methodologies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e8.92\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e13.71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e4.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep\u0026lt;0.0000*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eCaregiver Relationship\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e12.27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e14.52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e2.26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep=0.0065*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eChild Relationship\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e10.62\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e14.23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e3.62\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep=0.0028*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eGeneral Vision of Visit\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 117px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 119px;\"\u003e\n \u003cp\u003e11.04\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1.04\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ep=0.2545\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Home visit quality, public policy, implementation at scale, feasibility and acceptability","lastPublishedDoi":"10.21203/rs.3.rs-7768829/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7768829/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003ePrograma Crian\u0026ccedil;a Feliz (PCF) is Brazil's home visitation program aimed at enhancing early childhood development. Evaluations of the program have found significant program challenges and implementation barriers, including the lack of a structured curriculum, insufficient training, and little supervisory support. This study tests the revised content of the home visits and new implementation strategies aimed at addressing these barriers and enhancing the quality of PCF home visits.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThe implementation strategies were piloted across 8 diverse municipalities in an implementation feasibility trial. The new strategies were assessed using a one group pre-post analysis along with mixed methods to assess the extent to which they were acceptable, feasible, and associated with a change in home visit quality. A paired t-test and an independent t-test analysis were used to assess the change in home visit quality. The implementation outcomes were assessed with qualitative analysis and the Framework Method approach.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThe proposed home visitation guidelines, material, training, and supervision process were determined to be highly acceptable, feasible, and associated with improved quality of home visits. The home visit quality scores significantly increased by 14.68 points (SD\u0026thinsp;=\u0026thinsp;14.89, CI 95%: 7.27\u0026ndash;22.08, p\u0026thinsp;=\u0026thinsp;0.0006), according to the paired t-test. The study participants provide insightful suggestions for adaptations that can occur before testing the strategies more broadly.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThe study underscores the importance of tailoring implementation strategies to address specific barriers for home visitation programs. The positive response to the modified curriculum, training methods, and supervision indicates potential for broader application, both within Brazil and in similar programs globally.\u003c/p\u003e","manuscriptTitle":"An implementation strategy bundle to improve home visit quality of the national child development program in Brazil: An implementation feasibility trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-28 08:54:52","doi":"10.21203/rs.3.rs-7768829/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-11-19T16:40:23+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-11-19T15:17:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-24T05:55:04+00:00","index":"","fulltext":""},{"type":"submitted","content":"Implementation Science Communications","date":"2025-10-23T13:13:48+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"12d49582-cee7-461c-8397-0f10a5525f13","owner":[],"postedDate":"November 28th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-15T16:45:21+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-28 08:54:52","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7768829","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7768829","identity":"rs-7768829","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}