Replanting the Birthing Trees to Support Aboriginal and Torres Strait Islander Parents and Babies: Protocol for developmental evaluation of a comprehensive culturally responsive, trauma-aware, healing-informed, continuity of care(r) model

Replanting the Birthing Trees to Support Aboriginal and Torres Strait Islander Parents and Babies: Protocol for developmental evaluation of a comprehensive culturally responsive, trauma-aware, healing-informed, continuity of care(r) model | 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 Study protocol Replanting the Birthing Trees to Support Aboriginal and Torres Strait Islander Parents and Babies: Protocol for developmental evaluation of a comprehensive culturally responsive, trauma-aware, healing-informed, continuity of care(r) model Catherine Chamberlain, Jacqui Sundbery, Leonie Segal, Jacynta Krakouer, and 49 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4591637/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Aboriginal and Torres Strait Islander people experience intergenerational trauma as a legacy of the impacts of colonisation. Replanting the Birthing Trees (RBT) aims to transform compounding cycles of intergenerational trauma and harm to positively reinforcing cycles of intergenerational nurturing and recovery for Aboriginal and Torres Strait Islander parents and babies. This paper describes the protocol for developmental evaluation of the culturally responsive, trauma-aware, healing-informed, continuity of care(r) model to support Aboriginal and Torres Strait Islander parents during the first 2000 days (pregnancy, birth and the first five years after birth). Methods The RBT project will be conducted in partnership with seven health services across Victoria (Royal Women’s Hospital and Mercy Hospital for Women) and Western Australia (WA) (Armadale Hospital, Western Australian Country Health Service (Northam, Narrogin, Moora and Merredin)), Australia. The RBT project consists of five workstreams: a resource repository including support framework; culturally validated sensitive enquiry tools; workforce development and training; continuity of care(r) toolkit; and strategies to support families to stay together from the start. The Consolidated Framework for Implementation Research (CFIR) informs implementation strategies. Acceptability, feasibility, costs and effectiveness will be evaluated using mixed methods analysis of qualitative and quantitative data, collected using key stakeholder interviews; parent and service provider discussion groups and interviews; cost audit; knowledge attitude and practice surveys; pre and post implementation outcome data; interrupted time series analysis of routinely collected administrative linked data; and co-design workshops. Competitive funding and human research ethics committee approval were assessed against Indigenous research excellence criteria with protocols to ensure the cultural and emotional safety of participants and communities. Discussion Participatory action research approaches are used to foster reflective cycles on data within the research process. Findings will be shared in project newsletters, plain language summaries, presentations and publications. Aboriginal birth perinatal equity trauma Figures Figure 1 Strengths and limitations of this study This highly innovative project will build the infrastructure to enable seven services to provide a model of culturally responsive, trauma-aware, healing-informed, continuity of care(r) for Aboriginal and Torres Strait Islander parents during the perinatal period. Testing a comprehensive multi-component approach to generate reinforcing cycles of intergenerational nurturing and recovery for Aboriginal and Torres Strait Islander parents and babies. Best practice implementation science using consolidated frameworks and participatory approaches, with Aboriginal and Torres Strait Islander community-controlled governance arrangements. Mixed methods developmental evaluation approaches designed to engage stakeholders and provide action research data on barriers and enablers prior to implementation, and cost effectiveness and feasibility of overall approach. Indigenous research excellence criteria inform ethics and dissemination protocols. Background In Australia, Aboriginal and Torres Strait Islander ways of knowing, being and doing have fostered the development of physical, social, and emotional wellbeing in Aboriginal and Torres Strait Islander communities for millennia prior to European colonisation. 1–3 However, colonisation, violence and discrimination have led to and reinforce harmful compounding cycles of intergenerational and complex post-traumatic stress disorder (complex trauma). 4 Complex trauma, associated with earlier exposure to severe, repeated threats or abuse, 5 is a root cause of health inequities 6 7 and an international public health priority. 6 8 The World Health Organisation (WHO) 9 provides a framework for understanding compounding intergenerational effects of trauma impacting Aboriginal and Torres Strait Islander people. 4 Structural and interpersonal violence has led to increased early life exposure to childhood adversity, which can impair early development. 10 11 Socioeconomic disadvantage can compound this early adversity and lead to health-harming behaviours, 12 poor health 13 and economic 14 outcomes, including adverse pregnancy outcomes. 15 Critically, trauma can impact parents’ capacity to nurture their child, leading to intergenerational trauma. 16–18 Compounding cycles of intergenerational trauma are exemplified in high and persistently rising proportions of Aboriginal and Torres Strait Islander children in Out of Home Care (OOHC). 19 20 Pregnancy, birth, and the transition to becoming a parent is a critical time when both risk and protective factors for trauma-related distress and recovery converge with unique life-course opportunities. 21–24 During pregnancy, there is an increased risk for ‘triggering’ of trauma-related distress. For mothers, physiological and social changes in pregnancy and early parenthood, along with poor birth and infant outcomes, and the threat of child protection service involvement, can heighten trauma survival responses. However, the birth of a baby also offers a unique opportunity for healing and recovery, with the joy that comes from bonding and attachment. At this time we can Heal the Past by Nurturing the Future 7 and support parents to transform a ‘vicious’ cycle of trauma to a ‘virtuous’ cycle of nurturing 25 and recovery 24 . Pregnancy is also the first time since childhood that many adults have regular and frequent scheduled contacts with health services, and evidence shows access for Aboriginal and Torres Strait Islander women is lacking. 26 This offers a unique and timely opportunity to identify and support parents experiencing complex trauma. To be successful, this requires a highly skilled and well-supported workforce and system structural competence 27 to address complex social and emotional issues and ensure ‘safety’ in perinatal care extends to include holistic cultural, social and emotional safety. In a national survey of primary maternity care providers, 98% reported that trauma was a significant issue impacting Aboriginal and Torres Strait Islander parents; yet nearly half (43%) were ‘not satisfied’ with the ability of their service to address this. 28 More recent studies confirm that Aboriginal women frequently perceive available health services as culturally unsafe and health professionals are often inadequately trained and underprepared to work cross-culturally. 26 Aims and objectives RBT aims to improve perinatal support for Aboriginal and Torres Strait Islander parents to transform compounding cycles of intergenerational trauma and harm into positively reinforcing cycles of intergenerational nurturing and recovery. This highly innovative project will build the infrastructure to enable seven services to provide a model of culturally responsive, trauma-aware, healing-informed, continuity of care(r) for Aboriginal and Torres Strait Islander parents during the perinatal period. This paper outlines the conceptual model and protocol planned by a majority Aboriginal-led team to implement and conduct developmental evaluation of a comprehensive co-designed model using participatory action research, implementation science and a mixed methods developmental evaluation approach to assess acceptability, feasibility, costs and effectiveness of the model, while ensuring cultural, social and emotional safety for participants and communities. Methods/design Patient and public (community) involvement RBT builds on extensive prior research, involving rigorous community co-design around culturally responsive, trauma-aware, healing-informed, continuity of perinatal care, including the following programs: Healing the Past by Nurturing the Future (HPNF) a model of trauma-integrated perinatal care, co-designed with Aboriginal and Torres Strait Islander communities and key partner organisations. 29–41 The program objectives included improving trauma awareness, support, safe recognition and assessment in perinatal care for Aboriginal and Torres Strait Islander parents. Intervention Mapping (IM) was used - a planning approach which uses theory and evidence as foundations for taking an ecological approach to assessing and intervening in health problems and fostering community participation. 21 The co-design activities included participation of over 500 stakeholders from more than 50 institutions. 7 The team has completed four action research cycles to co-design a needs assessment and cultural safety framework; 34 and an innovative culturally grounded model of trauma-integrated perinatal care. The model is currently being piloted in one rural site in Victoria. This model includes resources to improve awareness of complex trauma among healthcare staff and Aboriginal and Torres Strait Islander parents; a support framework for healthcare staff and parents to access culturally responsive, trauma-integrated care; advocacy to Support Aboriginal and Torres Strait Islander Families to Stay Together from the Start (SAFeST Start). It also includes a guide to sensitive enquiry and training for healthcare staff, to ensure that the benefits of identification, using a newly validated Aboriginal and Torres Strait Islander Complex Trauma and Strengths Questionnaire (ACTSQ) for culturally-grounded assessment for individual planning for Aboriginal and Torres Strait Islander families outweigh possible harms. Continuity of Carer Models are a health service and system approach shown to reduce preterm births and improve perinatal survival. 42 43 These approaches enable care to be received from a single or small group of practitioners which is considered essential for establishing trusting relationships between service providers and parents, a fundamental pre-requisite for providing culturally responsive, effective trauma-aware, healing-informed support for parents experiencing trauma. Aboriginal and Torres Strait Islander women currently have limited access to midwifery continuity of carer models. 16 44 Even so, there are now several programs demonstrating the acceptability and effectiveness of continuity of carer models for Aboriginal and Torres Strait Islander parents. 43,45 This includes the Baggarrook midwifery group practice implemented at the Royal Women’s Hospital and the Nangnak Baban Murrup midwifery group practice implemented at the Mercy Hospital for Women, both of which have demonstrated improvements in parent experiences 46 and perinatal and infant health outcomes. 47 Baby Coming You Ready? (BCYR) centres around a strengths-based and healing-focused holistic digitised assessment for Aboriginal and Torres Strait Islander mothers-to-be/mothers and fathers. 48–50 BCYR has been shown to generate trust, engagement, honest disclosure, relevant care-plans and a deepened therapeutic friendship between mothers, fathers and their health-care provider. 50 The BCYR program includes mandatory training for healthcare providers supporting program integrity. The digital assessment is initiated in a stand-alone appointment early in antenatal care. Sensitive touch-screen images, Aboriginal voice-overs and skip logic guide both the mother, father and health-care provider through a holistic social, emotional, cultural and spiritual wellbeing ‘narrative inquiry’. The parent selects images they relate to, capturing strengths, supports and concerns. Reflecting on and prioritising these, they then design their own solutions. An automatically woman/family centred care-plan is generated that uploads into the health record and MyHealth Record. This process initiates an ongoing model for perinatal care. The RBT governance structure reflects Aboriginal and Torres Strait Islander rights to self-determination as outlined in the United Nations Declaration on the Rights of Indigenous Peoples (article 3) . 51 In addition, it is aligned with the four priority reform pillars of the National Agreement on Closing the Gap 52 , emphasizing: ( 1 ) formal partnerships and shared decision-making with governance group representation of Aboriginal peak bodies, chairing by the governance group by a senior Aboriginal and Torres Strait Islander Elder (DF), who receive four monthly reports from senior Aboriginal chief investigators (CC/RM); ( 2 ) building the community-controlled sector by embedding a policy-officer at the National Aboriginal Community Controlled Health Organisation (NACCHO) will ensure outcome delivery; ( 3 ) contributing evidence to transform government institutions, particularly health care provision and statutory child protection services; and ( 4 ) and prioritising access to and construction of data and information at a regional level, consistent with Indigenous Data Sovereignty Principles. 53 Context and setting RBT is being implemented and evaluated in two Australian jurisdictions (Victoria and WA) with seven health services (three metropolitan, four rural). The two participating sites in Victoria are) the Royal Women’s Hospital (RWH; Baggarrook midwifery group practice and the Mercy Hospital for Women (Nangnak Baban Murrup midwifery group practice). These are tertiary metropolitan services which proactively offer culturally responsive, continuity of midwifery care for > 200 Aboriginal and Torres Strait Islander mothers per year. The WA sites are Armadale Hospital in outer urban Perth, and four rural regional services managed by the WA Country Health Service Wheatbelt region including Avon Valley (Northam) and Narrogin Midwifery Group Practices, the Wheatbelt Aboriginal Health Service Aboriginal Liaison Officer – Maternal. Armadale Hospital offered Boodjari Yorga which provides Aboriginal-led midwifery and Aboriginal Health Worker (AHW) programs to approximately 130 women annually. Northam and Narrogin Health Services offer birthing care for low risk births. Moora and Merredin Health Services offer antenatal/postnatal care, with transfer for birth to either Northam or Perth based secondary or tertiary maternity hospitals (impacts approximately 47% (35 of 75) of Wheatbelt Aboriginal women annually depending on assessed risk). These aforementioned WA services piloted the innovative BCYR perinatal program between 2021 and 2023. This successful mixed methods pilot included triangulated data analysis using women’s deidentified data (n = 300) and interviews from 47 midwives, eight managers and 45 women. These are ideal demonstration implementation sites for this project. Each includes ( 1 ) an exemplar model of culturally responsive continuity of midwifery care(r) for Aboriginal and Torres Strait Islander women/parents – an essential foundation for integrating trauma-aware, healing-informed care; ( 2 ) support for parents with complex social and emotional needs and trialling assessment tools; and ( 3 ) significant numbers of Aboriginal and Torres Strait Islander parents and infants seeking care. We have selected a mix of metropolitan and rural services to ensure the infrastructure and learning co-produced in this developmental evaluation project is more likely to be broadly applicable across a diverse range of settings, to build infrastructure for future scale-up and to evaluate implementation success and outcomes across settings. Methodological approach RBT uses an overarching developmental evaluation 54 approach, consistent with action research methodology. We chose this model as it facilitates the adaptive development of change initiatives in complex and dynamic environments, and has been used in successfully in Aboriginal and Torres Strait Islander primary health care. 54 It will enable the RBT teams to “respond to stakeholder feedback and apply learning in real-time to successfully refine theory-informed processes, tailor findings to stakeholders and context, and support the project’s dissemination and knowledge co-production aim - contributing to the production of robust, useable research findings for informing policy and system change.” 54 We will also use the RE-AIM evaluation approach to assess viability of future implementation at scale using multi-phase mixed methods. The RE-AIM Model describes the public health impact of an intervention as a function of five factors: reach, efficacy, adoption, implementation, and maintenance 55 . This framework is consistent with systems-based and social-ecological thinking as well as community-based and public health interventions. A central premise of the RE-AIM Model is that the ultimate influence of an intervention is due to its combined effects on the above five evaluative factors. Implementation Implementation will draw on the Diffusion of Innovations in Service Organisations conceptual model 56 and Consolidated Framework for Implementation Research (CFIR). 57 The distributive Diffusion of Innovations in Service Organisations conceptual model identifies the main factors that influence the uptake and implementation in organisations, to optimise diffusion, dissemination and sustainability. 56 We will apply this model using the subsequently developed CFIR in our co-design approach ensuring that we achieve shared meanings and values, effective knowledge transfer, and to capture user-led innovation. 56–58 An implementation and evaluation subgroup will use the CFIR to guide design of the RBT implementation methods. The CFIR has five major domains: intervention characteristics (e.g., evidence strength and quality), outer setting (e.g., patient needs and resources), inner setting (e.g., culture, leadership engagement), characteristics of the individuals involved, and the process of implementation (e.g., plan, evaluate, and reflect). The CFIR has been used successfully to bring together knowledge translation and participatory action research approaches in Aboriginal and Torres Strait islander healthcare. 59 Conceptual model: integrating western and Indigenous worldviews and methodologies The metaphor Replanting the Birthing Trees illustrates our innovative co-designed comprehensive model (Fig. 1) aligned with the reform pillars of the National Agreement on Closing the Gap, grounded in Aboriginal and Torres Strait Islander knowledge and informed by research evidence to build the infrastructure for translation and scale-up. The model includes community-controlled governance and an implementation and evaluation working group using a developmental evaluation approach, with five core workstreams: - A resource repository and support directory – development and delivery of resources for parents, service providers and decision-makers on culturally responsive, trauma-aware, healing-informed care. Implementation of culturally co-designed validated tools for sensitive enquiry : BCYR, ACTSQ. Workforce development through creating resources to enable culturally responsive, trauma-aware, healing-informed care: and delivery of flexible online and face-to-face training, as well as mentoring for ‘wellbeing champions’ (HPNF and BCYR training). Culturally responsive, trauma-aware, healing-informed, continuity-of-care(r) . A toolkit will be developed with partner organisations to support services elsewhere to implement these models. This will include a suite of standards of practise and tools, a core outcome set for evaluation, and exploration of options for organisational endorsement. Supporting Aboriginal Families to Stay Together from the Start resources and advocacy. This includes co-designing a ‘wise counsel’ model of care for trauma-integrated, culturally responsive service provision and decision-making with Aboriginal and Torres Strait Islander organisations and community. This model aims to support Aboriginal and Torres Strait Islander parents and families interacting with child protection services during the perinatal period. Figure 1- Replanting the Birthing Trees conceptual model We have developed a program logic that underpins the model and explains the proposed mechanism of impact on healthcare staff and families, as well as a logic model for evaluation, which corresponds to the research questions (Supplementary file 1). In sum, we expect that service providers involved in the project will increase their knowledge, confidence and practices in supporting Aboriginal and Torres Strait Islander families and that as a result of receiving culturally responsive, trauma-aware, healing-informed, continuity of care(r) perinatal models of care, we will see positive health and socio-emotional outcomes for parents and babies. Site Implementation Teams (SITs) will be established to oversee implementation of the model as outlined in Fig. 1 and foster local ownership and community participation, identify and incorporate relevant practice-based evidence and resources, address structural barriers, and oversee local adaptations. The SIT will maintain records of all implementation activities including barriers and enablers to implementation, service provider characteristics and participation in training (eligible, offered, completed). Consistent with the developmental evaluation approach, the implementation and evaluation activities will be adapted in each jurisdiction and site to respond to the context and stage each site is at with regards to the components of the overall model. Evaluation activities Thie RBT project will assess the acceptability, feasibility, costs and effectiveness of a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model for Aboriginal and Torres Strait Islander families. Methods to address each of the research questions are listed in Table 1 . Consistent with a developmental evaluation approach, these activities will be adapted for each site based on feedback from key stakeholders. Table 1 Research questions and overview of methods Research Questions Methods( 1 ) Timing 1. What are the current practices in each of the seven sites to support Aboriginal and Torres Strait Islander women/parents during the antenatal/perinatal period? Key stakeholder interviews (n ~ 21–56) Pre-implementation and post implementation 2. What are the experiences of Aboriginal and Torres Strait Islander women/ parents receiving a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model? Yarning group with women/parents (n ~ 42–56) Pre implementation and 3-month post implementation 3. To what extent is the model of care implemented as intended? What modifications were made and why? What are the critical components of ‘good’ care? (fidelity). What are the barriers and enablers to implementation of a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model ( feasibility )? Discussion groups /interviews with service providers (N ~ 56–70) * Service provider feedback portal Pre implementation (feasibility only); 3-month post implementation 4. What are the costs and potential cost savings of implementing a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model? (costs) Cost audit During and post Implementation 5. What is the impact on knowledge, attitudes and practices of service providers who support Aboriginal and Torres Strait Islander parents and babies? (effectiveness) KAP (Knowledge, attitudes and practices) survey with service providers (N ~ 350) Baseline pre-training, post-training (during training), 3-month post implementation 6. What is the impact on health and socio-emotional outcomes for Aboriginal and Torres Strait Islander parents and babies? 6a Has this project reduced preterm births, NICU admissions, unborn notifications and OOHC admissions, 6b What are the most useful potential items for inclusion in a core outcome set? ( effectiveness ) Secondary data analysis (n ~ 500 in intervention sites plus control sites) Post implementation and post evaluation 7. How can the data be interpreted and translated into action beyond this project? Co-design workshop KAP survey with service providers (n ~ 60 per workshop) Post implementation and post evaluation Our approaches for recruitment and conducting culturally appropriate mixed methods research have been developed in collaboration with partners during extensive co-design. To maximise safety of participants, we will apply the cultural and emotional safety protocol developed during the co-design phase for this work. 34 The research activities designed to address each of the research questions and to evaluate the implementation process and outcomes of the model are described here: 1. Key stakeholder interviews Purpose: To assess organisational readiness for change and implementation enablers and barriers. Recruitment and sample: We will conduct key stakeholder interviews for each site. Participants will be invited if they are aged 18 years or over and employed in a role providing perinatal care to Aboriginal and Torres Strait Islander parents or in a management position related to maternity services, in the site area. Participants will be invited via flyers and information sessions conducted at sites and using snowballing techniques within the network. Data collection and analysis: Questions are aligned with the CFIR domains. Data from the interviews/discussion groups will be analysed using Braun and Clarke’s (2006) 35 six stages of thematic analysis to identify core themes, with reference to relevant theoretical frameworks. The audio recordings from the interviews/discussion groups will be transcribed and read by at least two researchers. Data involving Aboriginal and Torres Strait Islander people will be analysed by at least one Aboriginal and/or Torres Strait Islander researcher. 2. Yarning groups with parents Purpose: To understand experiences of care pre and post implementation. Recruitment and sample: We will conduct pre-implementation and post-implementation yarning groups 60 with Aboriginal and Torres Strait Islander parents from each service about their experiences of the perinatal care they received. Parents will be given information about the project via flyers and from service providers, and if interested, give permission to be contacted by the research team. Relational networks will also be utilised, with parents recruited through community and/or social networks as appropriate. We will give parents the option to participate either in a one-on-one interview or, if they prefer to bring a partner/family member/friend or support person along, we will offer a discussion group. Pre-implementation, parents will be invited who are 16 years or older and identify as Aboriginal and/or Torres Strait Islander, can speak English and have a child five-years-old or younger and have received perinatal care at the hospital site previously. A post-implementation cohort of parents who gave birth since the start of implementation will be invited to participate three-months post implementation. There may be some parents who take part in both discussion groups. Data collection and analysis: Discussions will be semi-structured with experienced interviewers sharing a story and using yarning methodology and broad open-ended questions. For example, “Thinking about the birth of your child: what were you hoping for?”, “What were the things that went well?”, and “if you were going back again, what would you change?” Parents will also be given the option of attending a creative expression session where they will have the opportunity to produce a creative piece of artwork e.g. painting, drawing poem, which reflects their previous experience and responses to interview questions. For the post implementation yarning group, additional questions will explore if they accessed any resources related to the project (i.e. BCYR program, resource repository), and their experiences with them (benefits or harms). Parents who participate will be given a supermarket voucher and small gift. Data will be analysed using thematic analysis outlined above with de-identified visual representations used to supplement the themes. 3. Discussion groups/interviews with service providers and feedback portal Purpose: To assess organizational readiness to change and readiness for a trauma-informed approach. Recruitment and sample: Information sessions will be held at each service to provide an overview of the project and stages. The research team will explain the option to participate in the feedback and evaluation activities, including discussion groups. We will conduct discussion groups/interviews with 6–10 service providers in each service aged 18 years or over who work in service site areas in a role associated with the delivery of perinatal care, express interest in participating and provide informed consent, before implementation and 3 months after implementation. Data collection and analysis: Pre-implementation, the discussion group will include semi-structured interview questions (adapted version of the Barriers and Enablers to Trauma-Informed Care Implementation (BETICI)) 41 and a demographic questionnaire. Post implementation, another 6–10 service providers will participate in a discussion group where they will be asked to describe the differences before and after implementation. Additional post implementation questions will ask about what are the Most Significant Changes that have occurred, whether they have worked well (or not) and why. All staff at our seven implementation sites involved in perinatal care provision will also be invited to provide reflections on the project implementation via a feedback portal developed in REDCap. Staff who consent to take part in the feedback portal will be invited to fill out the feedback form related to positive or challenging examples. Service providers who complete face-to-face training will be invited by a follow up email to provide feedback via the portal. There will also be a link to the feedback portal on the site intranet and on flyers at sites. The feedback form will be anonymous to increase participation. Free text boxes will be provided for answers. All qualitative data will be analysed using thematic analysis outlined above. Quantitative data will be analysed using standard descriptive methods. 4. Audit of service usage and cost post-implementation Purpose: To assess costs of the model, including cost effectiveness of outcomes. The model of care builds on existing service delivery. Data collection and analysis: The cost of implementation will draw on a thorough description of all program components, the specific activities involved, time allocated by the study/investigator team by occupation group (to which the appropriate hourly wage is applied), payment to contractors for services to support implementation, cost of consumables, including development of all materials, including parent information, training materials, service directory, delivery of materials, training of personnel – cost of trainer and time of attendees to determine a total program cost. Allocation of costs to families and children will be based on the number of families involved in the program delivery to allocate costs of consumables/recurrent costs, and for development costs (e.g., parent resources) using a 10-year timeframe, projected number of families who will ultimately access materials, and cost for resource updates. To determine the additional costs of staff time spent completing training, mentoring, and reflective practice we will work closely with the SIT who will record this data. Costing data will ultimately be combined with health outcome data in an economic evaluation that compares additional costs associated with the model of care to changes in health outcomes (cost-consequence analysis). The cost of scaling up and modelling forward will be based on a 10-year time frame and the regions to be covered drawing on program costings to inform the model parameters. 5. KAP survey with service providers Purpose: Assess changes in service provider knowledge, attitudes and practices (KAP) pre and post training. Recruitment and sample: Service providers aged 18 years or over who work with parents in the sites and register for any of the training programs offered as part of Replanting the Birthing Trees will be asked to complete the KAP survey immediately before commencing training and again after the training session. Data collection and analysis: The survey will include KAP items, demographic questions and a measure of job satisfaction. At follow-up, additional questions will be asked to assess satisfaction with the training, relevance of the training and improvements to the training. 6. Secondary analysis (using interrupted time series) of routinely collected linked administrative data Purpose: To examine the impact of the model of care on health and socio-emotional outcomes ( effectiveness ). Recruitment and sample: We will conduct an interrupted time series analysis to assess the effectiveness of the implementation of the model of care on health and soceio-emotional outcomes. For the implementation site hospitals, we will use public hospital admitted patient records to identify Aboriginal and Torres Strait Islander woman (and their babies) who have given birth at implementation site hospitals before and during the implementation period. We will also try to obtain a control group of hospitals that have not implemented the model of care to better understand if the post implementation outcomes are due to the impact of the model or other factors. Data collection and analysis: An interrupted time series study of parent and infant outcomes. Secondary data will be linked across eight routinely collected health and social care administrative data sets, including: perinatal, emergency presentations, admitted patient, maternal and child health databases, birth registry, death registry, birthing outcomes, hospital separations and child protection databases. Data will be de-identified and linked by data custodians in Victoria and statisticians in WA based on the data generated by the external data linkage organisations. Data extraction will cover two years pre and post implementation. Primary outcomes Proportion of children who are the subject of a protection (CP) notification(s) and proportion entering out-of-home care; antenatal and maternal child health (MCH) nurse visits to 12 months (number, % of scheduled and % meeting all scheduled). Antenatal and Maternal Child Health (MCH) attendance is an indicator of how ‘safe’ parents’ feel. Secondary outcomes: Routinely collected perinatal data: smoking; gestational weight gain greater or less than recommended; gestation; mode of birth; maternal and infant anemia; APGAR scores; birthweight; neonatal special care admissions; breastfeeding; completion of 12-month vaccinations; child hospitalizations, still in hospital at 28 days. Due to the nature of the intervention, which is designed to strengthen organisational capacity and awareness, we expect a gradual change in slope rather than an immediate step change post-intervention. Segmented regression models will be fitted to estimate the change in trends before and after implementation (i.e., slope change). 7. Co-design workshops Purpose: As we have done for the previous three national stakeholder workshops for previous phases of the Healing the Past by Nurturing the Future project held in Victoria, Northern Territory and South Australia, and BCYR stakeholder workshops in WA, we will invite approximately 60 key stakeholders to participate as co-researchers in three co-design workshops to enable broader collaboration in program development, implementation and evaluation. Recruitment and sample: Key stakeholders are service providers, researchers, policymakers, and community leaders working to address complex trauma. Key stakeholders are identified through consultation and using snowballing during an ongoing process of advertising about the project through Aboriginal and academic health networks, professional meetings and conferences. People expressing interest in the project area continue to be included in an email list and receive updates about the project. Data collection and analysis: The first workshop will involve refining the proposed ‘Wise Counsel’ model of care for parents and families involved with child protection services during the perinatal period. The second will refine implementation approaches, and the third workshop will discuss preliminary evaluation and outcome data and plans for dissemination. Data from the project will be presented in the workshops and workshop discussion data will be analysed descriptively (e.g. level of agreement with proposals) and using thematic analysis. Sample size calculations The desired sample size for qualitative interviews/discussion groups has been selected noting the concept of saturation in qualitative research. Saturation is met when no new salient information is obtained from conducting further interviews. For quantitative data, all parents meeting the eligibility criteria will be invited to participate in interviews to assess the impact on parenting self-efficacy, complex trauma, and health outcomes – pre and post implementation. Data from all parents in the implementation and control sites giving birth two years before and two years after the intervention will be included in interrupted times series analyses. Confirming, Renegotiating, Discontinuation or Withdrawal of Participants from Study It will be clearly stated in all communications that the participant is free to withdraw from study at any time, for any reason, without prejudice, and with no obligation to give the reason for withdrawal. Participants will be informed that if they choose to withdraw from the study, the valid data provided will be deleted if it has not been deidentified at that point. Ethics and dissemination Ethics The funding proposal and human research ethics submission for this research was assessed against Indigenous research criteria developed to promote ethical and culturally appropriate research. This includes the National Health and Medical Research Council Ethical Guidelines for Research with Aboriginal and Torres Strait Islander people 61 and Australian Institute of Aboriginal and Torres Strait Islander Studies Code of Ethics for Aboriginal and Torres Strait Islander Research 2020 62 which are grounded in the core rights to self-determination. We have received ethics approval for Victoria from the St Vincents Human Research Ethics committee (St Vincents HREC 148/23), Mercy Health HREC (Mercy HREC Ref 2023-032) and Western Australian Aboriginal Health Ethics Committee (HREC1297). We have developed an emotional and cultural safety protocol based on community consultation which will guide all project activities. 34 This implementation project is being conducted using participatory action research and implementation principles. Action research participative processes are embedded in the research design (e.g. workshops, and discussion groups). Other dissemination processes will include: Opportunity to comment on draft findings and provision of final findings to all participants in an academic and plain language format. Newsletter updates with project highlights and links to further information sent to all stakeholders three times a year. All project reports, summaries, presentations and newsletters provided on a designated project website. Presentations/in-service offered to partner organisation staff at community meetings. Presentations in conferences and Aboriginal and Torres Strait Islander research forums. All publications in open-access format with links available on the project website. Use of art, presentations and other culturally relevant mediums to share information. Policy briefs of relevant findings for policy developed with governance group. Findings will be shared with the project implementation sites as available with a view to supporting the facilitation of continuous quality improvement processes. Parents and service providers who participate in any of the research activities will be given the opportunity when providing consent to indicate that they wish to receive a copy of the study findings in a community feedback format by providing either their email or postal address. At the conclusion of the study, those who have indicated they would like to be informed of the findings will be emailed/posted a plain language summary of the study findings. Discussion This comprehensive mixed methods implementation study aims to improve culturally responsive, trauma-aware and healing informed care for Aboriginal and Torres Strait Islander parents in the First 2000 days. We use a pragmatic participatory action research approach that utilizes existing data sources and collects implementation data that can be rapidly fed back to partner services to improve implementation. This research builds on work currently being implemented with the HPNF project 63 , and BCYR?, Baggarrook midwifery group practice and the Nangnak Baban Murrup midwifery group practice programs. 46,47 This is a rigorous mixed methods evaluation plan for a comprehensive intervention to improve outcomes for Aboriginal and Torres Strait islander families. However, there are limitations. We could not randomly allocate individuals to an intervention due to the organisation wide approach. Therefore there is a greater risk of confounding of outcomes due to effects other than the intervention. We are mitigating this risk by careful documentation and journalling of activities and potential confounders during the project, and utilising a control group for the secondary data analysis. Applied research projects with rigorous evaluation of outcomes are urgently needed for Closing the Gap in health inequities which are disproportionately experienced by Aboriginal and Torres Strait Islander families. We anticipate that there will be many learnings from this implementation project about what works, what doesn’t, and the barriers and enablers to improving care for Aboriginal and Torres Strait Islander families in both urban and rural settings. Abbreviations ACTSQ Aboriginal Complex Trauma and Strengths Questionnaire AHW Aboriginal Health Worker BCYR Baby Coming, You Ready? BETICI Barriers and Enablers to Trauma Informed Care Implementation CFIR Consolidated Framework for Implementation Research HPNF Healing the Past by Nurturing the Future KAP Knowledge, Attitudes, Practice MCH Maternal Child Health NACCHO National Aboriginal Community Controlled Health Organisation OOHC Out of Home Care RBT Replanting the Birthing Trees SIT Site Implementation Teams WHO World Health Organisation Declarations Authors' contributions: CC drafted the protocol. CC, JS, LS, JK, ML, JD, JK, EM, ML, NMB, AK, PF, EG, CAA, KAJ, HH, HH, AK, AE, GB, RW, TR, BK, SA, DF, DB, TB, HS, SS, SH, KS, SH, KS, KC, JF, PR, NP, SK, TR, JA, DC, AL, MB, CP, VR, SO and RM authors reviewed and contributed to the draft of this manuscript. Funding statement: This work was supported by the Medical Research Future Fund grant number MRFMB000010. Data availability statement: No data are available to be requested from this protocol. Competing interests statement. 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Service","correspondingAuthor":false,"prefix":"","firstName":"Phillippa","middleName":"","lastName":"Reppington","suffix":""},{"id":320546404,"identity":"3594820b-0f11-4a99-be1f-a756f042601f","order_by":42,"name":"Naomi Priest","email":"","orcid":"","institution":"Onemda Aboriginal and Torres Strait Islander Health and Wellbeing, Melbourne School of Population and Global Health, University of Melbourne","correspondingAuthor":false,"prefix":"","firstName":"Naomi","middleName":"","lastName":"Priest","suffix":""},{"id":320546405,"identity":"447fc889-02c1-466e-8a86-36c27e0bd71f","order_by":43,"name":"Sally Kendall","email":"","orcid":"","institution":"Centre for Health Services Studies, University of Kent","correspondingAuthor":false,"prefix":"","firstName":"Sally","middleName":"","lastName":"Kendall","suffix":""},{"id":320546406,"identity":"694c3e67-5dfa-44b5-b4e1-b116079144e1","order_by":44,"name":"Tracy Reibel","email":"","orcid":"","institution":"Ngangk Yira Institute for Change, Murdoch University","correspondingAuthor":false,"prefix":"","firstName":"Tracy","middleName":"","lastName":"Reibel","suffix":""},{"id":320546407,"identity":"3b896e86-f062-48ca-b73c-fc3404eca513","order_by":45,"name":"Julie Andrews","email":"","orcid":"","institution":"Gabra Biik Wurruwila Wutja Indigenous Research Centre, La Trobe University","correspondingAuthor":false,"prefix":"","firstName":"Julie","middleName":"","lastName":"Andrews","suffix":""},{"id":320546408,"identity":"05412532-9da9-4278-8f5b-fa283eba7b81","order_by":46,"name":"Dave Carmody","email":"","orcid":"","institution":"Victorian Aboriginal Child Care Agency","correspondingAuthor":false,"prefix":"","firstName":"Dave","middleName":"","lastName":"Carmody","suffix":""},{"id":320546409,"identity":"835b0c8e-f4e6-4b2c-b1aa-ed62d4ddc99d","order_by":47,"name":"Adrienne Lipscomb","email":"","orcid":"","institution":"Victorian Aboriginal Child Care Agency","correspondingAuthor":false,"prefix":"","firstName":"Adrienne","middleName":"","lastName":"Lipscomb","suffix":""},{"id":320546410,"identity":"95048031-da09-4460-b722-19edb07615bd","order_by":48,"name":"Maddison Bell","email":"","orcid":"","institution":"School of Allied Health, Curtain University","correspondingAuthor":false,"prefix":"","firstName":"Maddison","middleName":"","lastName":"Bell","suffix":""},{"id":320546411,"identity":"44b39405-fdef-457b-902e-ec6e0cf8392f","order_by":49,"name":"Christine Parry","email":"","orcid":"","institution":"Boodjari Yorgas Midwifery Group Practice, East Metropolitan Health Service","correspondingAuthor":false,"prefix":"","firstName":"Christine","middleName":"","lastName":"Parry","suffix":""},{"id":320546412,"identity":"0d950297-f6b8-4b92-9977-f5fe7e2b6dfd","order_by":50,"name":"Vanessa Russ","email":"","orcid":"","institution":"Onemda Aboriginal and Torres Strait Islander Health and Wellbeing, Melbourne School of Population and Global Health, University of Melbourne","correspondingAuthor":false,"prefix":"","firstName":"Vanessa","middleName":"","lastName":"Russ","suffix":""},{"id":320546413,"identity":"f8770c5f-b0b3-452b-835c-926529a8f621","order_by":51,"name":"Shakira R Onwuka","email":"","orcid":"","institution":"Onemda Aboriginal and Torres Strait Islander Health and Wellbeing, Melbourne School of Population and Global Health, University of Melbourne","correspondingAuthor":false,"prefix":"","firstName":"Shakira","middleName":"R","lastName":"Onwuka","suffix":""},{"id":320546414,"identity":"ae94663a-5c50-412b-94e0-de94b88ed20f","order_by":52,"name":"Rhonda Marriott","email":"","orcid":"","institution":"Ngangk Yira Institute for Change, Murdoch University","correspondingAuthor":false,"prefix":"","firstName":"Rhonda","middleName":"","lastName":"Marriott","suffix":""}],"badges":[],"createdAt":"2024-06-17 04:00:32","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4591637/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4591637/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":60605133,"identity":"3bcd3729-c3cf-49b2-8989-c26a75d208ea","added_by":"auto","created_at":"2024-07-18 16:41:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":524907,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eReplanting the Birthing Trees conceptual model\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e","description":"","filename":"Figure1RBTconceptualModel1.png","url":"https://assets-eu.researchsquare.com/files/rs-4591637/v1/00beec6518852cfbab62691f.png"},{"id":92212494,"identity":"482c8e82-7198-4376-bbbd-82d64d62289a","added_by":"auto","created_at":"2025-09-25 21:46:32","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1918203,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4591637/v1/6ca1ca45-bf92-451d-8f59-04ef5f9a36cb.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Replanting the Birthing Trees to Support Aboriginal and Torres Strait Islander Parents and Babies: Protocol for developmental evaluation of a comprehensive culturally responsive, trauma-aware, healing-informed, continuity of care(r) model","fulltext":[{"header":"Strengths and limitations of this study","content":"\u003cul\u003e\n \u003cli\u003eThis highly innovative project will build the infrastructure to enable seven services to provide a model of culturally responsive, trauma-aware, healing-informed, continuity of care(r) for Aboriginal and Torres Strait Islander parents during the perinatal period.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTesting a comprehensive multi-component approach to generate reinforcing cycles of intergenerational nurturing and recovery for Aboriginal and Torres Strait Islander parents and babies.\u003c/li\u003e\n \u003cli\u003eBest practice implementation science using consolidated frameworks and participatory approaches, with Aboriginal and Torres Strait Islander community-controlled governance arrangements.\u003c/li\u003e\n \u003cli\u003eMixed methods developmental evaluation approaches designed to engage stakeholders and provide action research data on barriers and enablers prior to implementation, and cost effectiveness and feasibility of overall approach.\u003c/li\u003e\n \u003cli\u003eIndigenous research excellence criteria inform ethics and dissemination protocols.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eIn Australia, Aboriginal and Torres Strait Islander ways of knowing, being and doing have fostered the development of physical, social, and emotional wellbeing in Aboriginal and Torres Strait Islander communities for millennia prior to European colonisation.\u003csup\u003e1\u0026ndash;3\u003c/sup\u003e However, colonisation, violence and discrimination have led to and reinforce harmful compounding cycles of intergenerational and complex post-traumatic stress disorder (complex trauma).\u003csup\u003e4\u003c/sup\u003e Complex trauma, associated with earlier exposure to severe, repeated threats or abuse,\u003csup\u003e5\u003c/sup\u003e is a root cause of health inequities\u003csup\u003e6 7\u003c/sup\u003e and an international public health priority.\u003csup\u003e6 8\u003c/sup\u003e The World Health Organisation (WHO)\u003csup\u003e9\u003c/sup\u003e provides a framework for understanding compounding intergenerational effects of trauma impacting Aboriginal and Torres Strait Islander people.\u003csup\u003e4\u003c/sup\u003e Structural and interpersonal violence has led to increased early life exposure to childhood adversity, which can impair early development.\u003csup\u003e10 11\u003c/sup\u003e Socioeconomic disadvantage can compound this early adversity and lead to health-harming behaviours,\u003csup\u003e12\u003c/sup\u003e poor health\u003csup\u003e13\u003c/sup\u003e and economic\u003csup\u003e14\u003c/sup\u003e outcomes, including adverse pregnancy outcomes.\u003csup\u003e15\u003c/sup\u003e Critically, trauma can impact parents\u0026rsquo; capacity to nurture their child, leading to intergenerational trauma.\u003csup\u003e16\u0026ndash;18\u003c/sup\u003e Compounding cycles of intergenerational trauma are exemplified in high and persistently rising proportions of Aboriginal and Torres Strait Islander children in Out of Home Care (OOHC).\u003csup\u003e19 20\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ePregnancy, birth, and the transition to becoming a parent is a critical time when both risk and protective factors for trauma-related distress and recovery converge with unique life-course opportunities.\u003csup\u003e21\u0026ndash;24\u003c/sup\u003e During pregnancy, there is an increased risk for \u0026lsquo;triggering\u0026rsquo; of trauma-related distress. For mothers, physiological and social changes in pregnancy and early parenthood, along with poor birth and infant outcomes, and the threat of child protection service involvement, can heighten trauma survival responses. However, the birth of a baby also offers a unique opportunity for healing and recovery, with the joy that comes from bonding and attachment. At this time we can Heal the Past by Nurturing the Future\u003csup\u003e7\u003c/sup\u003e and support parents to transform a \u0026lsquo;vicious\u0026rsquo; cycle of trauma to a \u0026lsquo;virtuous\u0026rsquo; cycle of nurturing \u003csup\u003e25\u003c/sup\u003e and recovery\u003csup\u003e24\u003c/sup\u003e. Pregnancy is also the first time since childhood that many adults have regular and frequent scheduled contacts with health services, and evidence shows access for Aboriginal and Torres Strait Islander women is lacking.\u003csup\u003e26\u003c/sup\u003e This offers a unique and timely opportunity to identify and support parents experiencing complex trauma. To be successful, this requires a highly skilled and well-supported workforce and system structural competence \u003csup\u003e27\u003c/sup\u003e to address complex social and emotional issues and ensure \u0026lsquo;safety\u0026rsquo; in perinatal care extends to include holistic cultural, social and emotional safety. In a national survey of primary maternity care providers, 98% reported that trauma was a significant issue impacting Aboriginal and Torres Strait Islander parents; yet nearly half (43%) were \u0026lsquo;not satisfied\u0026rsquo; with the ability of their service to address this.\u003csup\u003e28\u003c/sup\u003e More recent studies confirm that Aboriginal women frequently perceive available health services as culturally unsafe and health professionals are often inadequately trained and underprepared to work cross-culturally.\u003csup\u003e26\u003c/sup\u003e\u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003eAims and objectives\u003c/h2\u003e \u003cp\u003e RBT aims to improve perinatal support for Aboriginal and Torres Strait Islander parents to transform compounding cycles of intergenerational trauma and harm into positively reinforcing cycles of intergenerational nurturing and recovery. This highly innovative project will build the infrastructure to enable seven services to provide a model of culturally responsive, trauma-aware, healing-informed, continuity of care(r) for Aboriginal and Torres Strait Islander parents during the perinatal period.\u003c/p\u003e \u003cp\u003eThis paper outlines the conceptual model and protocol planned by a majority Aboriginal-led team to implement and conduct developmental evaluation of a comprehensive co-designed model using participatory action research, implementation science and a mixed methods developmental evaluation approach to assess acceptability, feasibility, costs and effectiveness of the model, while ensuring cultural, social and emotional safety for participants and communities.\u003c/p\u003e \u003c/div\u003e"},{"header":"Methods/design","content":"\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003ePatient and public (community) involvement\u003c/h2\u003e \u003cp\u003eRBT builds on extensive prior research, involving rigorous community co-design around culturally responsive, trauma-aware, healing-informed, continuity of perinatal care, including the following programs:\u003c/p\u003e \u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cem\u003eHealing the Past by Nurturing the Future (HPNF)\u003c/em\u003e a model of trauma-integrated perinatal care, co-designed with Aboriginal and Torres Strait Islander communities and key partner organisations.\u003csup\u003e29\u0026ndash;41\u003c/sup\u003e The program objectives included improving trauma awareness, support, safe recognition and assessment in perinatal care for Aboriginal and Torres Strait Islander parents. Intervention Mapping (IM) was used - a planning approach which uses theory and evidence as foundations for taking an ecological approach to assessing and intervening in health problems and fostering community participation.\u003csup\u003e21\u003c/sup\u003e The co-design activities included participation of over 500 stakeholders from more than 50 institutions.\u003csup\u003e7\u003c/sup\u003e The team has completed four action research cycles to co-design a needs assessment and cultural safety framework;\u003csup\u003e34\u003c/sup\u003e and an innovative culturally grounded model of trauma-integrated perinatal care. The model is currently being piloted in one rural site in Victoria. This model includes resources to improve awareness of complex trauma among healthcare staff and Aboriginal and Torres Strait Islander parents; a support framework for healthcare staff and parents to access culturally responsive, trauma-integrated care; advocacy to Support Aboriginal and Torres Strait Islander Families to Stay Together from the Start (SAFeST Start). It also includes a guide to sensitive enquiry and training for healthcare staff, to ensure that the benefits of identification, using a newly validated Aboriginal and Torres Strait Islander Complex Trauma and Strengths Questionnaire (ACTSQ) for culturally-grounded assessment for individual planning for Aboriginal and Torres Strait Islander families outweigh possible harms.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cem\u003eContinuity of Carer Models\u003c/em\u003e are a health service and system approach shown to reduce preterm births and improve perinatal survival.\u003csup\u003e42 43\u003c/sup\u003e These approaches enable care to be received from a single or small group of practitioners which is considered essential for establishing trusting relationships between service providers and parents, a fundamental pre-requisite for providing culturally responsive, effective trauma-aware, healing-informed support for parents experiencing trauma. Aboriginal and Torres Strait Islander women currently have limited access to midwifery continuity of carer models.\u003csup\u003e16 44\u003c/sup\u003e Even so, there are now several programs demonstrating the acceptability and effectiveness of continuity of carer models for Aboriginal and Torres Strait Islander parents.\u003csup\u003e43,45\u003c/sup\u003e This includes the Baggarrook midwifery group practice implemented at the Royal Women\u0026rsquo;s Hospital and the Nangnak Baban Murrup midwifery group practice implemented at the Mercy Hospital for Women, both of which have demonstrated improvements in parent experiences\u003csup\u003e46\u003c/sup\u003e and perinatal and infant health outcomes.\u003csup\u003e47\u003c/sup\u003e\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cem\u003eBaby Coming You Ready? (BCYR)\u003c/em\u003e centres around a strengths-based and healing-focused holistic digitised assessment for Aboriginal and Torres Strait Islander mothers-to-be/mothers and fathers.\u003csup\u003e48\u0026ndash;50\u003c/sup\u003e BCYR has been shown to generate trust, engagement, honest disclosure, relevant care-plans and a deepened therapeutic friendship between mothers, fathers and their health-care provider.\u003csup\u003e50\u003c/sup\u003e The BCYR program includes mandatory training for healthcare providers supporting program integrity. The digital assessment is initiated in a stand-alone appointment early in antenatal care. Sensitive touch-screen images, Aboriginal voice-overs and skip logic guide both the mother, father and health-care provider through a holistic social, emotional, cultural and spiritual wellbeing \u0026lsquo;narrative inquiry\u0026rsquo;. The parent selects images they relate to, capturing strengths, supports and concerns. Reflecting on and prioritising these, they then design their own solutions. An automatically woman/family centred care-plan is generated that uploads into the health record and MyHealth Record. This process initiates an ongoing model for perinatal care.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e \u003cp\u003eThe RBT \u003cb\u003egovernance structure\u003c/b\u003e reflects Aboriginal and Torres Strait Islander rights to self-determination as outlined in the United Nations Declaration on the Rights of Indigenous Peoples (article 3) .\u003csup\u003e51\u003c/sup\u003e In addition, it is aligned with the four priority reform pillars of the National Agreement on Closing the Gap\u003csup\u003e52\u003c/sup\u003e, emphasizing: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) formal partnerships and shared decision-making with governance group representation of Aboriginal peak bodies, chairing by the governance group by a senior Aboriginal and Torres Strait Islander Elder (DF), who receive four monthly reports from senior Aboriginal chief investigators (CC/RM); (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) building the community-controlled sector by embedding a policy-officer at the National Aboriginal Community Controlled Health Organisation (NACCHO) will ensure outcome delivery; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) contributing evidence to transform government institutions, particularly health care provision and statutory child protection services; and (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) and prioritising access to and construction of data and information at a regional level, consistent with Indigenous Data Sovereignty Principles.\u003csup\u003e53\u003c/sup\u003e\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eContext and setting\u003c/h3\u003e\n\u003cp\u003eRBT is being implemented and evaluated in two Australian jurisdictions (Victoria and WA) with seven health services (three metropolitan, four rural). The two participating sites in Victoria are) the Royal Women\u0026rsquo;s Hospital (RWH; Baggarrook midwifery group practice and the Mercy Hospital for Women (Nangnak Baban Murrup midwifery group practice). These are tertiary metropolitan services which proactively offer culturally responsive, continuity of midwifery care for \u0026gt;\u0026thinsp;200 Aboriginal and Torres Strait Islander mothers per year.\u003c/p\u003e \u003cp\u003eThe WA sites are Armadale Hospital in outer urban Perth, and four rural regional services managed by the WA Country Health Service Wheatbelt region including Avon Valley (Northam) and Narrogin Midwifery Group Practices, the Wheatbelt Aboriginal Health Service Aboriginal Liaison Officer \u0026ndash; Maternal. Armadale Hospital offered Boodjari Yorga which provides Aboriginal-led midwifery and Aboriginal Health Worker (AHW) programs to approximately 130 women annually. Northam and Narrogin Health Services offer birthing care for low risk births. Moora and Merredin Health Services offer antenatal/postnatal care, with transfer for birth to either Northam or Perth based secondary or tertiary maternity hospitals (impacts approximately 47% (35 of 75) of Wheatbelt Aboriginal women annually depending on assessed risk). These aforementioned WA services piloted the innovative BCYR perinatal program between 2021 and 2023. This successful mixed methods pilot included triangulated data analysis using women\u0026rsquo;s deidentified data (n\u0026thinsp;=\u0026thinsp;300) and interviews from 47 midwives, eight managers and 45 women.\u003c/p\u003e \u003cp\u003eThese are ideal demonstration implementation sites for this project. Each includes (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) an exemplar model of culturally responsive continuity of midwifery care(r) for Aboriginal and Torres Strait Islander women/parents \u0026ndash; an essential foundation for integrating trauma-aware, healing-informed care; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) support for parents with complex social and emotional needs and trialling assessment tools; and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) significant numbers of Aboriginal and Torres Strait Islander parents and infants seeking care. We have selected a mix of metropolitan and rural services to ensure the infrastructure and learning co-produced in this developmental evaluation project is more likely to be broadly applicable across a diverse range of settings, to build infrastructure for future scale-up and to evaluate implementation success and outcomes across settings.\u003c/p\u003e\n\u003ch3\u003eMethodological approach\u003c/h3\u003e\n\u003cp\u003eRBT uses an overarching developmental evaluation\u003csup\u003e54\u003c/sup\u003e approach, consistent with action research methodology. We chose this model as it facilitates the adaptive development of change initiatives in complex and dynamic environments, and has been used in successfully in Aboriginal and Torres Strait Islander primary health care.\u003csup\u003e54\u003c/sup\u003e It will enable the RBT teams to \u0026ldquo;respond to stakeholder feedback and apply learning in real-time to successfully refine theory-informed processes, tailor findings to stakeholders and context, and support the project\u0026rsquo;s dissemination and knowledge co-production aim - contributing to the production of robust, useable research findings for informing policy and system change.\u0026rdquo;\u003csup\u003e54\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eWe will also use the RE-AIM evaluation approach to assess viability of future implementation at scale using multi-phase mixed methods. The RE-AIM Model describes the public health impact of an intervention as a function of five factors: reach, efficacy, adoption, implementation, and maintenance \u003csup\u003e55\u003c/sup\u003e. This framework is consistent with systems-based and social-ecological thinking as well as community-based and public health interventions. A central premise of the RE-AIM Model is that the ultimate influence of an intervention is due to its combined effects on the above five evaluative factors.\u003c/p\u003e\n\u003ch3\u003eImplementation\u003c/h3\u003e\n\u003cp\u003eImplementation will draw on the Diffusion of Innovations in Service Organisations conceptual model\u003csup\u003e56\u003c/sup\u003e and Consolidated Framework for Implementation Research (CFIR).\u003csup\u003e57\u003c/sup\u003e The distributive Diffusion of Innovations in Service Organisations conceptual model identifies the main factors that influence the uptake and implementation in organisations, to optimise diffusion, dissemination and sustainability.\u003csup\u003e56\u003c/sup\u003e We will apply this model using the subsequently developed CFIR in our co-design approach ensuring that we achieve shared meanings and values, effective knowledge transfer, and to capture user-led innovation.\u003csup\u003e56\u0026ndash;58\u003c/sup\u003e An implementation and evaluation subgroup will use the CFIR to guide design of the RBT implementation methods. The CFIR has five major domains: intervention characteristics (e.g., evidence strength and quality), outer setting (e.g., patient needs and resources), inner setting (e.g., culture, leadership engagement), characteristics of the individuals involved, and the process of implementation (e.g., plan, evaluate, and reflect). The CFIR has been used successfully to bring together knowledge translation and participatory action research approaches in Aboriginal and Torres Strait islander healthcare.\u003csup\u003e59\u003c/sup\u003e\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eConceptual model: integrating western and Indigenous worldviews and methodologies\u003c/h2\u003e \u003cp\u003eThe metaphor \u003cem\u003eReplanting the Birthing Trees\u003c/em\u003e illustrates our innovative co-designed comprehensive model (Fig.\u0026nbsp;1) aligned with the reform pillars of the National Agreement on Closing the Gap, grounded in Aboriginal and Torres Strait Islander knowledge and informed by research evidence to build the infrastructure for translation and scale-up. The model includes community-controlled governance and an implementation and evaluation working group using a developmental evaluation approach, with five core workstreams: -\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eA \u003cem\u003eresource repository and support directory\u003c/em\u003e \u0026ndash; development and delivery of resources for parents, service providers and decision-makers on culturally responsive, trauma-aware, healing-informed care.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eImplementation of \u003cem\u003eculturally co-designed validated tools for sensitive enquiry\u003c/em\u003e: BCYR, ACTSQ.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cem\u003eWorkforce development\u003c/em\u003e through creating resources to enable culturally responsive, trauma-aware, healing-informed care: and delivery of flexible online and face-to-face training, as well as mentoring for \u0026lsquo;wellbeing champions\u0026rsquo; (HPNF and BCYR training).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cem\u003eCulturally responsive, trauma-aware, healing-informed, continuity-of-care(r)\u003c/em\u003e. A toolkit will be developed with partner organisations to support services elsewhere to implement these models. This will include a suite of standards of practise and tools, a core outcome set for evaluation, and exploration of options for organisational endorsement.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cem\u003eSupporting Aboriginal Families to Stay Together from the Start\u003c/em\u003e resources and advocacy. This includes co-designing a \u0026lsquo;wise counsel\u0026rsquo; model of care for trauma-integrated, culturally responsive service provision and decision-making with Aboriginal and Torres Strait Islander organisations and community. This model aims to support Aboriginal and Torres Strait Islander parents and families interacting with child protection services during the perinatal period.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 1- Replanting the Birthing Trees conceptual model\u0026thinsp;\u0026lt;\u0026thinsp;insert here\u0026gt;\u003c/b\u003e \u003c/p\u003e \u003cp\u003eWe have developed a program logic that underpins the model and explains the proposed mechanism of impact on healthcare staff and families, as well as a logic model for evaluation, which corresponds to the research questions (Supplementary file 1). In sum, we expect that service providers involved in the project will increase their knowledge, confidence and practices in supporting Aboriginal and Torres Strait Islander families and that as a result of receiving culturally responsive, trauma-aware, healing-informed, continuity of care(r) perinatal models of care, we will see positive health and socio-emotional outcomes for parents and babies.\u003c/p\u003e \u003cp\u003eSite Implementation Teams (SITs) will be established to oversee implementation of the model as outlined in Fig.\u0026nbsp;1 and foster local ownership and community participation, identify and incorporate relevant practice-based evidence and resources, address structural barriers, and oversee local adaptations. The SIT will maintain records of all implementation activities including barriers and enablers to implementation, service provider characteristics and participation in training (eligible, offered, completed). Consistent with the developmental evaluation approach, the implementation and evaluation activities will be adapted in each jurisdiction and site to respond to the context and stage each site is at with regards to the components of the overall model.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eEvaluation activities\u003c/h3\u003e\n\u003cp\u003eThie RBT project will assess the acceptability, feasibility, costs and effectiveness of a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model for Aboriginal and Torres Strait Islander families. Methods to address each of the research questions are listed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Consistent with a developmental evaluation approach, these activities will be adapted for each site based on feedback from key stakeholders.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eResearch questions and overview of methods\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResearch Questions\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMethods(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTiming\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. What are the current practices in each of the seven sites to support Aboriginal and Torres Strait Islander women/parents during the antenatal/perinatal period?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eKey stakeholder interviews\u003c/b\u003e (n\u0026thinsp;~\u0026thinsp;21\u0026ndash;56)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePre-implementation and post implementation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2. What are the experiences of Aboriginal and Torres Strait Islander women/ parents receiving a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eYarning group with women/parents\u003c/b\u003e (n\u0026thinsp;~\u0026thinsp;42\u0026ndash;56)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePre implementation and 3-month post implementation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3. To what extent is the model of care implemented as intended? What modifications were made and why? What are the critical components of \u0026lsquo;good\u0026rsquo; care? \u003cem\u003e(fidelity).\u003c/em\u003e What are the barriers and enablers to implementation of a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model (\u003cem\u003efeasibility\u003c/em\u003e)?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eDiscussion groups /interviews with service providers\u003c/b\u003e (N\u0026thinsp;~\u0026thinsp;56\u0026ndash;70)\u003c/p\u003e \u003cp\u003e*\u003cb\u003eService provider feedback portal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePre implementation (feasibility only); 3-month post implementation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4. What are the \u003cem\u003ecosts and potential cost savings\u003c/em\u003e of implementing a culturally responsive, trauma-aware, healing-informed, continuity of care(r) model? \u003cem\u003e(costs)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eCost audit\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDuring and post Implementation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5. What is the impact on knowledge, attitudes and practices of service providers who support Aboriginal and Torres Strait Islander parents and babies? \u003cem\u003e(effectiveness)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eKAP (Knowledge, attitudes and practices) survey with service providers\u003c/b\u003e (N\u0026thinsp;~\u0026thinsp;350)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaseline pre-training, post-training (during training), 3-month post implementation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6. What is the impact on health and socio-emotional outcomes for Aboriginal and Torres Strait Islander parents and babies?\u003c/p\u003e \u003cp\u003e6a Has this project reduced preterm births, NICU admissions, unborn notifications and OOHC admissions,\u003c/p\u003e \u003cp\u003e6b What are the most useful potential items for inclusion in a core outcome set? (\u003cem\u003eeffectiveness\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eSecondary data analysis\u003c/b\u003e (n\u0026thinsp;~\u0026thinsp;500 in intervention sites plus control sites)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePost implementation and post evaluation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7. How can the data be interpreted and translated into action beyond this project?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eCo-design workshop\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eKAP survey with service providers\u003c/b\u003e (n\u0026thinsp;~\u0026thinsp;60 per workshop)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePost implementation and post evaluation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026lt;Insert\u003c/em\u003e Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e \u003cem\u003ehere\u0026gt;\u003c/em\u003e\u003c/p\u003e \u003cp\u003eOur approaches for recruitment and conducting culturally appropriate mixed methods research have been developed in collaboration with partners during extensive co-design. To maximise safety of participants, we will apply the cultural and emotional safety protocol developed during the co-design phase for this work.\u003csup\u003e34\u003c/sup\u003e The research activities designed to address each of the research questions and to evaluate the implementation process and outcomes of the model are described here:\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e1. Key stakeholder interviews\u003c/h2\u003e \u003cp\u003ePurpose: To assess organisational readiness for change and implementation enablers and barriers.\u003c/p\u003e \u003cp\u003eRecruitment and sample: We will conduct key stakeholder interviews for each site. Participants will be invited if they are aged 18 years or over and employed in a role providing perinatal care to Aboriginal and Torres Strait Islander parents or in a management position related to maternity services, in the site area. Participants will be invited via flyers and information sessions conducted at sites and using snowballing techniques within the network.\u003c/p\u003e \u003cp\u003eData collection and analysis: Questions are aligned with the CFIR domains. Data from the interviews/discussion groups will be analysed using Braun and Clarke\u0026rsquo;s (2006)\u003csup\u003e35\u003c/sup\u003e six stages of thematic analysis to identify core themes, with reference to relevant theoretical frameworks. The audio recordings from the interviews/discussion groups will be transcribed and read by at least two researchers. Data involving Aboriginal and Torres Strait Islander people will be analysed by at least one Aboriginal and/or Torres Strait Islander researcher.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e2. Yarning groups with parents\u003c/h2\u003e \u003cp\u003ePurpose: To understand experiences of care pre and post implementation.\u003c/p\u003e \u003cp\u003eRecruitment and sample: We will conduct pre-implementation and post-implementation yarning groups\u003csup\u003e60\u003c/sup\u003e with Aboriginal and Torres Strait Islander parents from each service about their experiences of the perinatal care they received. Parents will be given information about the project via flyers and from service providers, and if interested, give permission to be contacted by the research team. Relational networks will also be utilised, with parents recruited through community and/or social networks as appropriate. We will give parents the option to participate either in a one-on-one interview or, if they prefer to bring a partner/family member/friend or support person along, we will offer a discussion group.\u003c/p\u003e \u003cp\u003ePre-implementation, parents will be invited who are 16 years or older and identify as Aboriginal and/or Torres Strait Islander, can speak English and have a child five-years-old or younger and have received perinatal care at the hospital site previously. A post-implementation cohort of parents who gave birth since the start of implementation will be invited to participate three-months post implementation. There may be some parents who take part in both discussion groups.\u003c/p\u003e \u003cp\u003eData collection and analysis: Discussions will be semi-structured with experienced interviewers sharing a story and using yarning methodology and broad open-ended questions. For example, \u0026ldquo;Thinking about the birth of your child: what were you hoping for?\u0026rdquo;, \u0026ldquo;What were the things that went well?\u0026rdquo;, and \u0026ldquo;if you were going back again, what would you change?\u0026rdquo; Parents will also be given the option of attending a creative expression session where they will have the opportunity to produce a creative piece of artwork e.g. painting, drawing poem, which reflects their previous experience and responses to interview questions. For the post implementation yarning group, additional questions will explore if they accessed any resources related to the project (i.e. BCYR program, resource repository), and their experiences with them (benefits or harms). Parents who participate will be given a supermarket voucher and small gift. Data will be analysed using thematic analysis outlined above with de-identified visual representations used to supplement the themes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003e3. Discussion groups/interviews with service providers and feedback portal\u003c/h2\u003e \u003cp\u003ePurpose: To assess organizational readiness to change and readiness for a trauma-informed approach.\u003c/p\u003e \u003cp\u003eRecruitment and sample: Information sessions will be held at each service to provide an overview of the project and stages. The research team will explain the option to participate in the feedback and evaluation activities, including discussion groups. We will conduct discussion groups/interviews with 6\u0026ndash;10 service providers in each service aged 18 years or over who work in service site areas in a role associated with the delivery of perinatal care, express interest in participating and provide informed consent, before implementation and 3 months after implementation.\u003c/p\u003e \u003cp\u003eData collection and analysis: Pre-implementation, the discussion group will include semi-structured interview questions (adapted version of the Barriers and Enablers to Trauma-Informed Care Implementation (BETICI))\u003csup\u003e41\u003c/sup\u003e and a demographic questionnaire. Post implementation, another 6\u0026ndash;10 service providers will participate in a discussion group where they will be asked to describe the differences before and after implementation. Additional post implementation questions will ask about what are the Most Significant Changes that have occurred, whether they have worked well (or not) and why. All staff at our seven implementation sites involved in perinatal care provision will also be invited to provide reflections on the project implementation via a feedback portal developed in REDCap. Staff who consent to take part in the feedback portal will be invited to fill out the feedback form related to positive or challenging examples. Service providers who complete face-to-face training will be invited by a follow up email to provide feedback via the portal. There will also be a link to the feedback portal on the site intranet and on flyers at sites. The feedback form will be anonymous to increase participation. Free text boxes will be provided for answers. All qualitative data will be analysed using thematic analysis outlined above. Quantitative data will be analysed using standard descriptive methods.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e4. Audit of service usage and cost post-implementation\u003c/h2\u003e \u003cp\u003ePurpose: To assess costs of the model, including cost effectiveness of outcomes. The model of care builds on existing service delivery.\u003c/p\u003e \u003cp\u003eData collection and analysis: The cost of implementation will draw on a thorough description of all program components, the specific activities involved, time allocated by the study/investigator team by occupation group (to which the appropriate hourly wage is applied), payment to contractors for services to support implementation, cost of consumables, including development of all materials, including parent information, training materials, service directory, delivery of materials, training of personnel \u0026ndash; cost of trainer and time of attendees to determine a total program cost. Allocation of costs to families and children will be based on the number of families involved in the program delivery to allocate costs of consumables/recurrent costs, and for development costs (e.g., parent resources) using a 10-year timeframe, projected number of families who will ultimately access materials, and cost for resource updates.\u003c/p\u003e \u003cp\u003eTo determine the additional costs of staff time spent completing training, mentoring, and reflective practice we will work closely with the SIT who will record this data.\u003c/p\u003e \u003cp\u003eCosting data will ultimately be combined with health outcome data in an economic evaluation that compares additional costs associated with the model of care to changes in health outcomes (cost-consequence analysis). The cost of scaling up and modelling forward will be based on a 10-year time frame and the regions to be covered drawing on program costings to inform the model parameters.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e5. KAP survey with service providers\u003c/h2\u003e \u003cp\u003ePurpose: Assess changes in service provider knowledge, attitudes and practices (KAP) pre and post training.\u003c/p\u003e \u003cp\u003eRecruitment and sample: Service providers aged 18 years or over who work with parents in the sites and register for any of the training programs offered as part of Replanting the Birthing Trees will be asked to complete the KAP survey immediately before commencing training and again after the training session.\u003c/p\u003e \u003cp\u003eData collection and analysis: The survey will include KAP items, demographic questions and a measure of job satisfaction. At follow-up, additional questions will be asked to assess satisfaction with the training, relevance of the training and improvements to the training.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003e6. Secondary analysis (using interrupted time series) of routinely collected linked administrative data\u003c/h2\u003e \u003cp\u003ePurpose: To examine the impact of the model of care on health and socio-emotional outcomes (\u003cem\u003eeffectiveness\u003c/em\u003e).\u003c/p\u003e \u003cp\u003eRecruitment and sample: We will conduct an interrupted time series analysis to assess the effectiveness of the implementation of the model of care on health and soceio-emotional outcomes. For the implementation site hospitals, we will use public hospital admitted patient records to identify Aboriginal and Torres Strait Islander woman (and their babies) who have given birth at implementation site hospitals before and during the implementation period. We will also try to obtain a control group of hospitals that have not implemented the model of care to better understand if the post implementation outcomes are due to the impact of the model or other factors.\u003c/p\u003e \u003cp\u003eData collection and analysis: An interrupted time series study of parent and infant outcomes. Secondary data will be linked across eight routinely collected health and social care administrative data sets, including: perinatal, emergency presentations, admitted patient, maternal and child health databases, birth registry, death registry, birthing outcomes, hospital separations and child protection databases. Data will be de-identified and linked by data custodians in Victoria and statisticians in WA based on the data generated by the external data linkage organisations. Data extraction will cover two years pre and post implementation.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003ePrimary outcomes\u003c/strong\u003e \u003cp\u003eProportion of children who are the subject of a protection (CP) notification(s) and proportion entering out-of-home care; antenatal and maternal child health (MCH) nurse visits to 12 months (number, % of scheduled and % meeting all scheduled). Antenatal and Maternal Child Health (MCH) attendance is an indicator of how \u0026lsquo;safe\u0026rsquo; parents\u0026rsquo; feel.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eSecondary outcomes: Routinely collected perinatal data: smoking; gestational weight gain greater or less than recommended; gestation; mode of birth; maternal and infant anemia; APGAR scores; birthweight; neonatal special care admissions; breastfeeding; completion of 12-month vaccinations; child hospitalizations, still in hospital at 28 days. Due to the nature of the intervention, which is designed to strengthen organisational capacity and awareness, we expect a gradual change in slope rather than an immediate step change post-intervention. Segmented regression models will be fitted to estimate the change in trends before and after implementation (i.e., slope change).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003e7. Co-design workshops\u003c/h2\u003e \u003cp\u003ePurpose: As we have done for the previous three national stakeholder workshops for previous phases of the Healing the Past by Nurturing the Future project held in Victoria, Northern Territory and South Australia, and BCYR stakeholder workshops in WA, we will invite approximately 60 key stakeholders to participate as co-researchers in three co-design workshops to enable broader collaboration in program development, implementation and evaluation. Recruitment and sample: Key stakeholders are service providers, researchers, policymakers, and community leaders working to address complex trauma. Key stakeholders are identified through consultation and using snowballing during an ongoing process of advertising about the project through Aboriginal and academic health networks, professional meetings and conferences. People expressing interest in the project area continue to be included in an email list and receive updates about the project.\u003c/p\u003e \u003cp\u003eData collection and analysis: The first workshop will involve refining the proposed \u0026lsquo;Wise Counsel\u0026rsquo; model of care for parents and families involved with child protection services during the perinatal period. The second will refine implementation approaches, and the third workshop will discuss preliminary evaluation and outcome data and plans for dissemination. Data from the project will be presented in the workshops and workshop discussion data will be analysed descriptively (e.g. level of agreement with proposals) and using thematic analysis.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eSample size calculations\u003c/h2\u003e \u003cp\u003eThe desired sample size for qualitative interviews/discussion groups has been selected noting the concept of saturation in qualitative research. Saturation is met when no new salient information is obtained from conducting further interviews. For quantitative data, all parents meeting the eligibility criteria will be invited to participate in interviews to assess the impact on parenting self-efficacy, complex trauma, and health outcomes \u0026ndash; pre and post implementation. Data from all parents in the implementation and control sites giving birth two years before and two years after the intervention will be included in interrupted times series analyses.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eConfirming, Renegotiating, Discontinuation or Withdrawal of Participants from Study\u003c/h2\u003e \u003cp\u003eIt will be clearly stated in all communications that the participant is free to withdraw from study at any time, for any reason, without prejudice, and with no obligation to give the reason for withdrawal. Participants will be informed that if they choose to withdraw from the study, the valid data provided will be deleted if it has not been deidentified at that point.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eEthics and dissemination\u003c/h2\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003eEthics\u003c/h2\u003e \u003cp\u003eThe funding proposal and human research ethics submission for this research was assessed against Indigenous research criteria developed to promote ethical and culturally appropriate research. This includes the National Health and Medical Research Council Ethical Guidelines for Research with Aboriginal and Torres Strait Islander people\u003csup\u003e61\u003c/sup\u003e and Australian Institute of Aboriginal and Torres Strait Islander Studies Code of Ethics for Aboriginal and Torres Strait Islander Research 2020\u003csup\u003e62\u003c/sup\u003e which are grounded in the core rights to self-determination. We have received ethics approval for Victoria from the St Vincents Human Research Ethics committee (St Vincents HREC 148/23), Mercy Health HREC (Mercy HREC Ref 2023-032) and Western Australian Aboriginal Health Ethics Committee (HREC1297). We have developed an emotional and cultural safety protocol based on community consultation which will guide all project activities.\u003csup\u003e34\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis implementation project is being conducted using participatory action research and implementation principles. Action research participative processes are embedded in the research design (e.g. workshops, and discussion groups). Other dissemination processes will include:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eOpportunity to comment on draft findings and provision of final findings to all participants in an academic and plain language format.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eNewsletter updates with project highlights and links to further information sent to all stakeholders three times a year.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAll project reports, summaries, presentations and newsletters provided on a designated project website.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePresentations/in-service offered to partner organisation staff at community meetings.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePresentations in conferences and Aboriginal and Torres Strait Islander research forums.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAll publications in open-access format with links available on the project website.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUse of art, presentations and other culturally relevant mediums to share information.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePolicy briefs of relevant findings for policy developed with governance group.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eFindings will be shared with the project implementation sites as available with a view to supporting the facilitation of continuous quality improvement processes. Parents and service providers who participate in any of the research activities will be given the opportunity when providing consent to indicate that they wish to receive a copy of the study findings in a community feedback format by providing either their email or postal address. At the conclusion of the study, those who have indicated they would like to be informed of the findings will be emailed/posted a plain language summary of the study findings.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003e This comprehensive mixed methods implementation study aims to improve culturally responsive, trauma-aware and healing informed care for Aboriginal and Torres Strait Islander parents in the First 2000 days. We use a pragmatic participatory action research approach that utilizes existing data sources and collects implementation data that can be rapidly fed back to partner services to improve implementation.\u003c/p\u003e \u003cp\u003eThis research builds on work currently being implemented with the HPNF project\u003csup\u003e63\u003c/sup\u003e, and BCYR?, Baggarrook midwifery group practice and the Nangnak Baban Murrup midwifery group practice programs.\u003csup\u003e46,47\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis is a rigorous mixed methods evaluation plan for a comprehensive intervention to improve outcomes for Aboriginal and Torres Strait islander families. However, there are limitations. We could not randomly allocate individuals to an intervention due to the organisation wide approach. Therefore there is a greater risk of confounding of outcomes due to effects other than the intervention. We are mitigating this risk by careful documentation and journalling of activities and potential confounders during the project, and utilising a control group for the secondary data analysis.\u003c/p\u003e \u003cp\u003eApplied research projects with rigorous evaluation of outcomes are urgently needed for Closing the Gap in health inequities which are disproportionately experienced by Aboriginal and Torres Strait Islander families. We anticipate that there will be many learnings from this implementation project about what works, what doesn\u0026rsquo;t, and the barriers and enablers to improving care for Aboriginal and Torres Strait Islander families in both urban and rural settings.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eACTSQ\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Aboriginal Complex Trauma and Strengths Questionnaire\u003c/p\u003e\n\u003cp\u003eAHW\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Aboriginal Health Worker\u003c/p\u003e\n\u003cp\u003eBCYR\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Baby Coming, You Ready?\u003c/p\u003e\n\u003cp\u003eBETICI\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Barriers and Enablers to Trauma Informed Care Implementation\u003c/p\u003e\n\u003cp\u003eCFIR\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Consolidated Framework for Implementation Research\u003c/p\u003e\n\u003cp\u003eHPNF \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Healing the Past by Nurturing the Future\u003c/p\u003e\n\u003cp\u003eKAP \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Knowledge, Attitudes, Practice\u003c/p\u003e\n\u003cp\u003eMCH \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Maternal Child Health\u003c/p\u003e\n\u003cp\u003eNACCHO\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;National Aboriginal Community Controlled Health Organisation\u003c/p\u003e\n\u003cp\u003eOOHC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Out of Home Care\u003c/p\u003e\n\u003cp\u003eRBT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Replanting the Birthing Trees\u003c/p\u003e\n\u003cp\u003eSIT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Site Implementation Teams\u003c/p\u003e\n\u003cp\u003eWHO \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;World Health Organisation\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions:\u003c/strong\u003e CC drafted the protocol. CC, JS, LS, JK, ML, JD, JK, EM, ML, NMB, AK, PF, EG, CAA, KAJ, HH, HH, AK, AE, GB, RW, TR, BK, SA, DF, DB, TB, HS, SS, SH, KS, SH, KS, KC, JF, PR, NP, SK, TR, JA, DC, AL, MB, CP, VR, SO and RM authors reviewed and contributed to the draft of this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding statement:\u003c/strong\u003e This work was supported by the Medical Research Future Fund grant number MRFMB000010.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement:\u003c/strong\u003e No data are available to be requested from this protocol.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests statement.\u0026nbsp;\u003c/strong\u003eThere are no competing interests to declare.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLangton M. Grandmothers' Law, Company Business and Succession in Changing Aboriginal Land Tenure Systems. 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BMJ Open Accepted 11/6/2024.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Aboriginal, birth, perinatal, equity, trauma","lastPublishedDoi":"10.21203/rs.3.rs-4591637/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4591637/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAboriginal and Torres Strait Islander people experience intergenerational trauma as a legacy of the impacts of colonisation. Replanting the Birthing Trees (RBT) aims to transform compounding cycles of intergenerational trauma and harm to positively reinforcing cycles of intergenerational nurturing and recovery for Aboriginal and Torres Strait Islander parents and babies. This paper describes the protocol for developmental evaluation of the culturally responsive, trauma-aware, healing-informed, continuity of care(r) model to support Aboriginal and Torres Strait Islander parents during the first 2000 days (pregnancy, birth and the first five years after birth).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe RBT project will be conducted in partnership with seven health services across Victoria (Royal Women’s Hospital and Mercy Hospital for Women) and Western Australia (WA) (Armadale Hospital, Western Australian Country Health Service (Northam, Narrogin, Moora and Merredin)), Australia. The RBT project consists of five workstreams: a resource repository including support framework; culturally validated sensitive enquiry tools; workforce development and training; continuity of care(r) toolkit; and strategies to support families to stay together from the start. The Consolidated Framework for Implementation Research (CFIR) informs implementation strategies. Acceptability, feasibility, costs and effectiveness will be evaluated using mixed methods analysis of qualitative and quantitative data, collected using key stakeholder interviews; parent and service provider discussion groups and interviews; cost audit; knowledge attitude and practice surveys; pre and post implementation outcome data; interrupted time series analysis of routinely collected administrative linked data; and co-design workshops.\u003c/p\u003e\n\u003cp\u003eCompetitive funding and human research ethics committee approval were assessed against Indigenous research excellence criteria with protocols to ensure the cultural and emotional safety of participants and communities.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eParticipatory action research approaches are used to foster reflective cycles on data within the research process. Findings will be shared in project newsletters, plain language summaries, presentations and publications.\u003c/p\u003e","manuscriptTitle":"Replanting the Birthing Trees to Support Aboriginal and Torres Strait Islander Parents and Babies: Protocol for developmental evaluation of a comprehensive culturally responsive, trauma-aware, healing-informed, continuity of care(r) model","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-18 16:41:29","doi":"10.21203/rs.3.rs-4591637/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"82fa4e30-dcba-4266-a59a-ad3027cd6be5","owner":[],"postedDate":"July 18th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-09-25T21:38:25+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-18 16:41:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4591637","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4591637","identity":"rs-4591637","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}