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Effect of strengths-based, tiered, accessible resources and supports (STARS) for Kids project, a codesigned hybrid service delivery framework to identify and support child development, parent mental health and psychosocial needs among parents and carers of children aged 6 months to 3 years: a randomised controlled trial protocol.

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Title: Effect of strengths-based, tiered, accessible resources and supports (STARS) for Kids project, a codesigned hybrid service delivery framework to identify and support child development, parent mental health and psychosocial needs among parents and carers of children aged 6 months to 3 years: a randomised controlled trial protocol.
Authors: John JR; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia., Kohlhoff J; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Karitane, Villawood, New South Wales, Australia., Lambiase S; The Kids Research Institute Australia, Nedlands, Western Australia, Australia., Nicholls S; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Diez M; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Doyle KE; School of Rural Medicine, Charles Sturt University, Orange, New South Wales, Australia., Barr K; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia., Boydell K; Black Dog Institute, Randwick, New South Wales, Australia., Brennan C; First Steps Count, Taree, New South Wales, Australia., Carson T; First Steps Count, Taree, New South Wales, Australia., Lam-Cassettari C; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia., Cole J; The Kids Research Institute Australia, Nedlands, Western Australia, Australia., Dadich A; School of Business, Western Sydney University, Penrith, New South Wales, Australia., Descallar J; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia., Finlay-Jones A; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.; School of Population Health, Curtin University, Perth, Western Australia, Australia., Foster M; Biripi Aboriginal Corporation Medical Centre, Purfleet, New South Wales, Australia., Goldfeld S; Murdoch Children's Research Institute, Parkville, Victoria, Australia.; Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia., Grace R; Transforming Early Education and Child Health (TeEACH) Strategic Research Initiative, Western Sydney University, Campbelltown, New South Wales, Australia., Hodgins M; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia., Honisett S; Murdoch Children's Research Institute, Parkville, Victoria, Australia., Katsamangos B; Mission Australia, Sydney, New South Wales, Australia., Katz I; Social Policy Research Centre, Faculty of Arts and Social Science, University of New South Wales, Sydney, New South Wales, Australia., Kemp L; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; School of Nursing and Midwifery, Western Sydney University, Penrith, New South Wales, Australia., Khan F; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia., Kliendienst L; Biripi Aboriginal Corporation Medical Centre, Purfleet, New South Wales, Australia., Lawson K; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia., Lingam R; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia., McClean T; Uniting NSW.ACT, Kingston, Australian Capital Territory, Australia., Morton SMB; Research Institute for Innovative Solutions for Wellbeing and Health, University of Technology Sydney, Sydney, New South Wales, Australia., O'Loughlin G; Karitane, Villawood, New South Wales, Australia., Ostojic K; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Page A; Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia., Prescott S; School of Medicine, The University of Western Australia, Perth, Western Australia, Australia., Raman S; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Community Paediatrics, South Western Sydney Local Health District, Liverpool, New South Wales, Australia., Schmied V; School of Nursing and Midwifery, Western Sydney University, Penrith, New South Wales, Australia., Walker AK; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Neuroscience Research Australia, Randwick, New South Wales, Australia., Wallace A; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia., Young R; The Kids Research Institute Australia, Nedlands, Western Australia, Australia., Silva D; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.; School of Medicine, The University of Western Australia, Perth, Western Australia, Australia.; Joondalup Health Campus, Joondalup, Western Australia, Australia., Downs J; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.; School of Population Health, Curtin University, Perth, Western Australia, Australia., Woolfenden S; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.; Institute for Women, Children and their Families, SLHD, Camperdown, New South Wales, Australia., Eapen V; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia v.eapen@unsw.edu.au.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.
Corporate Authors: Ngarra Wakulda Aboriginal Community Consultation Group, STARS for Kids Research Group
Source: BMJ open [BMJ Open] 2026 Sep 29; Vol. 16 (9), pp. e122902. Date of Electronic Publication: 2026 Sep 29.
Publication Type: Clinical Trial Protocol; Journal Article
Language: English
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Imprint Name(s): Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
MeSH Terms: Caregivers*/psychology , Child Health Services*/organization & administration , Parents*/psychology , Child Development* , Mental Health*, Child, Preschool ; Female ; Humans ; Infant ; Australia ; Health Services Accessibility ; Research Design ; Randomized Controlled Trials as Topic
Abstract: Introduction: Inequitable access to early developmental support persists across both universal and specialised services for priority populations. However, real-world evidence on the impact of implementing proportionate universalism framework (universal plus targeted supports commensurate with needs) within service systems is limited. To address this gap, we aim to implement and evaluate a codesigned model of care called the Strengths-based, Tiered, Accessible Resources and Supports for Kids (hereafter, STARS for Kids) model to improve early identification and delivery of appropriate support for child developmental vulnerabilities, parental mental health and family psychosocial needs across the first 2000 days of life, from pregnancy to the start of school.
Methods and Analysis: This study will be conducted in three phases alongside the codesign phase that will be integrated across the life of the study. First, the impact evaluation phase will be conducted using a multisite, individually randomised controlled trial to evaluate the effectiveness of the STARS for Kids tiered care model (intervention group) against enhanced usual care (control group). Parents/carers of children aged 6 months to 3 years (140 per site) will be recruited using opportunistic contacts in three sites: (i) a multicultural site with a high immigrant population in South Western Sydney in New South Wales (NSW), Australia; (ii) a regional/rural site including an Aboriginal community on Biripi land in Taree in NSW; and (iii) a low socioeconomic site, the City of Wanneroo in Western Australia. Additionally, a nested trial will evaluate the My Toddler and Me Enhanced Video Programme intervention against enhanced usual care among children identified with emotional dysregulation. Second, the implementation evaluation phase will be conducted with consumers and service providers (approximately 15-20 per group and site). Underpinned by the consolidated framework for implementation research, it will evaluate the perceived feasibility, satisfaction, benefits, barriers and facilitators of the model. Third, the economic analysis and dynamic simulation modelling phase will ascertain the cost-benefits and model the impact of the STARS for Kids intervention across the life course for children and families. The primary outcome (parent or carer-reported completion of child developmental checks) and secondary outcomes (changes in child developmental vulnerabilities, parental mental health and family psychosocial needs between the intervention and control groups) will be compared by intention-to-treat analysis using generalised mixed models to account for group, time and interactions. Interview data from the implementation evaluation phase will be thematically analysed to identify, refine and integrate themes representing participant experiences.
Ethics and Dissemination: The South Western Sydney Local Health District Human Research Ethics Committee approved this protocol for the South Western Sydney and Taree sites in NSW (2024/ETH01146) and Ramsay Ethics approved this protocol for the Wanneroo site in Western Australia (2025/ETH/0002). Site-specific research governance approvals were granted for all three sites. Given the substantial proportion of Aboriginal and/or Torres Strait Islander communities in Taree, an Aboriginal Health and Medical Research Council ethics application was approved for the Taree site (2478/25). Findings from this study will be published in reports and refereed journals and presented at appropriate conferences and community forums following consultations with the relevant steering committees and consumer groups.
Trial Registration Number: ACTRN12624000806561.
(© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.)
Competing Interests: Competing interests: None declared.
Contributed Indexing: Keywords: Community child health; Delivery of Health Care, Integrated; Developmental neurology & neurodisability; MENTAL HEALTH; Randomized Controlled Trial; Social Support
Entry Date(s): Date Created: 20260929 Date Completed: 20260929 Latest Revision: 20260930
Update Code: 20261001
DOI: 10.1136/bmjopen-2026-122902
PMID: 42810805
Database: MEDLINE
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  Data: Effect of strengths-based, tiered, accessible resources and supports (STARS) for Kids project, a codesigned hybrid service delivery framework to identify and support child development, parent mental health and psychosocial needs among parents and carers of children aged 6 months to 3 years: a randomised controlled trial protocol.
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  Data: <searchLink fieldCode="AU" term="%22John+JR%22">John JR</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Kohlhoff+J%22">Kohlhoff J</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Karitane, Villawood, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Lambiase+S%22">Lambiase S</searchLink>; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Nicholls+S%22">Nicholls S</searchLink>; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Diez+M%22">Diez M</searchLink>; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Doyle+KE%22">Doyle KE</searchLink>; School of Rural Medicine, Charles Sturt University, Orange, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Barr+K%22">Barr K</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Boydell+K%22">Boydell K</searchLink>; Black Dog Institute, Randwick, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Brennan+C%22">Brennan C</searchLink>; First Steps Count, Taree, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Carson+T%22">Carson T</searchLink>; First Steps Count, Taree, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Lam-Cassettari+C%22">Lam-Cassettari C</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Cole+J%22">Cole J</searchLink>; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Dadich+A%22">Dadich A</searchLink>; School of Business, Western Sydney University, Penrith, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Descallar+J%22">Descallar J</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Finlay-Jones+A%22">Finlay-Jones A</searchLink>; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.; School of Population Health, Curtin University, Perth, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Foster+M%22">Foster M</searchLink>; Biripi Aboriginal Corporation Medical Centre, Purfleet, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Goldfeld+S%22">Goldfeld S</searchLink>; Murdoch Children's Research Institute, Parkville, Victoria, Australia.; Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.<br /><searchLink fieldCode="AU" term="%22Grace+R%22">Grace R</searchLink>; Transforming Early Education and Child Health (TeEACH) Strategic Research Initiative, Western Sydney University, Campbelltown, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Hodgins+M%22">Hodgins M</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Honisett+S%22">Honisett S</searchLink>; Murdoch Children's Research Institute, Parkville, Victoria, Australia.<br /><searchLink fieldCode="AU" term="%22Katsamangos+B%22">Katsamangos B</searchLink>; Mission Australia, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Katz+I%22">Katz I</searchLink>; Social Policy Research Centre, Faculty of Arts and Social Science, University of New South Wales, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Kemp+L%22">Kemp L</searchLink>; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; School of Nursing and Midwifery, Western Sydney University, Penrith, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Khan+F%22">Khan F</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Kliendienst+L%22">Kliendienst L</searchLink>; Biripi Aboriginal Corporation Medical Centre, Purfleet, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Lawson+K%22">Lawson K</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Lingam+R%22">Lingam R</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22McClean+T%22">McClean T</searchLink>; Uniting NSW.ACT, Kingston, Australian Capital Territory, Australia.<br /><searchLink fieldCode="AU" term="%22Morton+SMB%22">Morton SMB</searchLink>; Research Institute for Innovative Solutions for Wellbeing and Health, University of Technology Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22O'Loughlin+G%22">O'Loughlin G</searchLink>; Karitane, Villawood, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Ostojic+K%22">Ostojic K</searchLink>; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Page+A%22">Page A</searchLink>; Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Prescott+S%22">Prescott S</searchLink>; School of Medicine, The University of Western Australia, Perth, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Raman+S%22">Raman S</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Community Paediatrics, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Schmied+V%22">Schmied V</searchLink>; School of Nursing and Midwifery, Western Sydney University, Penrith, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Walker+AK%22">Walker AK</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.; Neuroscience Research Australia, Randwick, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Wallace+A%22">Wallace A</searchLink>; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Young+R%22">Young R</searchLink>; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Silva+D%22">Silva D</searchLink>; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.; School of Medicine, The University of Western Australia, Perth, Western Australia, Australia.; Joondalup Health Campus, Joondalup, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Downs+J%22">Downs J</searchLink>; The Kids Research Institute Australia, Nedlands, Western Australia, Australia.; School of Population Health, Curtin University, Perth, Western Australia, Australia.<br /><searchLink fieldCode="AU" term="%22Woolfenden+S%22">Woolfenden S</searchLink>; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.; Institute for Women, Children and their Families, SLHD, Camperdown, New South Wales, Australia.<br /><searchLink fieldCode="AU" term="%22Eapen+V%22">Eapen V</searchLink>; School of Clinical Medicine, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia v.eapen@unsw.edu.au.; Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.; Academic Unit of Infant, Child, and Adolescent Psychiatry Services, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.
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  Data: <searchLink fieldCode="CA" term="%22Ngarra+Wakulda+Aboriginal+Community+Consultation+Group%22">Ngarra Wakulda Aboriginal Community Consultation Group</searchLink><br /><searchLink fieldCode="CA" term="%22STARS+for+Kids+Research+Group%22">STARS for Kids Research Group</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22101552874%22">BMJ open</searchLink> [BMJ Open] 2026 Sep 29; Vol. 16 (9), pp. e122902. <i>Date of Electronic Publication: </i>2026 Sep 29.
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  Data: Clinical Trial Protocol; Journal Article
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  Data: English
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group+Ltd%22">BMJ Publishing Group Ltd </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101552874 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2044-6055 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2220446055%22">20446055 </searchLink><i>NLM ISO Abbreviation: </i>BMJ Open <i>Subsets: </i>MEDLINE
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  Data: <i>Original Publication</i>: [London] : BMJ Publishing Group Ltd, 2011-
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  Data: <searchLink fieldCode="MM" term="%22Caregivers%22">Caregivers*</searchLink>/<searchLink fieldCode="MM" term="%22Caregivers+psychology%22">psychology</searchLink> <br /><searchLink fieldCode="MM" term="%22Child+Health+Services%22">Child Health Services*</searchLink>/<searchLink fieldCode="MM" term="%22Child+Health+Services+organization+%26+administration%22">organization & administration</searchLink> <br /><searchLink fieldCode="MM" term="%22Parents%22">Parents*</searchLink>/<searchLink fieldCode="MM" term="%22Parents+psychology%22">psychology</searchLink> <br /><searchLink fieldCode="MM" term="%22Child+Development%22">Child Development*</searchLink> <br /><searchLink fieldCode="MM" term="%22Mental+Health%22">Mental Health*</searchLink><br /><searchLink fieldCode="MH" term="%22Child%2C+Preschool%22">Child, Preschool</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Infant%22">Infant</searchLink> ; <searchLink fieldCode="MH" term="%22Australia%22">Australia</searchLink> ; <searchLink fieldCode="MH" term="%22Health+Services+Accessibility%22">Health Services Accessibility</searchLink> ; <searchLink fieldCode="MH" term="%22Research+Design%22">Research Design</searchLink> ; <searchLink fieldCode="MH" term="%22Randomized+Controlled+Trials+as+Topic%22">Randomized Controlled Trials as Topic</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: Inequitable access to early developmental support persists across both universal and specialised services for priority populations. However, real-world evidence on the impact of implementing proportionate universalism framework (universal plus targeted supports commensurate with needs) within service systems is limited. To address this gap, we aim to implement and evaluate a codesigned model of care called the Strengths-based, Tiered, Accessible Resources and Supports for Kids (hereafter, STARS for Kids) model to improve early identification and delivery of appropriate support for child developmental vulnerabilities, parental mental health and family psychosocial needs across the first 2000 days of life, from pregnancy to the start of school.<br />Methods and Analysis: This study will be conducted in three phases alongside the codesign phase that will be integrated across the life of the study. First, the impact evaluation phase will be conducted using a multisite, individually randomised controlled trial to evaluate the effectiveness of the STARS for Kids tiered care model (intervention group) against enhanced usual care (control group). Parents/carers of children aged 6 months to 3 years (140 per site) will be recruited using opportunistic contacts in three sites: (i) a multicultural site with a high immigrant population in South Western Sydney in New South Wales (NSW), Australia; (ii) a regional/rural site including an Aboriginal community on Biripi land in Taree in NSW; and (iii) a low socioeconomic site, the City of Wanneroo in Western Australia. Additionally, a nested trial will evaluate the My Toddler and Me Enhanced Video Programme intervention against enhanced usual care among children identified with emotional dysregulation. Second, the implementation evaluation phase will be conducted with consumers and service providers (approximately 15-20 per group and site). Underpinned by the consolidated framework for implementation research, it will evaluate the perceived feasibility, satisfaction, benefits, barriers and facilitators of the model. Third, the economic analysis and dynamic simulation modelling phase will ascertain the cost-benefits and model the impact of the STARS for Kids intervention across the life course for children and families. The primary outcome (parent or carer-reported completion of child developmental checks) and secondary outcomes (changes in child developmental vulnerabilities, parental mental health and family psychosocial needs between the intervention and control groups) will be compared by intention-to-treat analysis using generalised mixed models to account for group, time and interactions. Interview data from the implementation evaluation phase will be thematically analysed to identify, refine and integrate themes representing participant experiences.<br />Ethics and Dissemination: The South Western Sydney Local Health District Human Research Ethics Committee approved this protocol for the South Western Sydney and Taree sites in NSW (2024/ETH01146) and Ramsay Ethics approved this protocol for the Wanneroo site in Western Australia (2025/ETH/0002). Site-specific research governance approvals were granted for all three sites. Given the substantial proportion of Aboriginal and/or Torres Strait Islander communities in Taree, an Aboriginal Health and Medical Research Council ethics application was approved for the Taree site (2478/25). Findings from this study will be published in reports and refereed journals and presented at appropriate conferences and community forums following consultations with the relevant steering committees and consumer groups.<br />Trial Registration Number: ACTRN12624000806561.<br /> (© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.)
– Name: Abstract
  Label: Competing Interests
  Group: Ab
  Data: Competing interests: None declared.
– Name: SubjectMinor
  Label: Contributed Indexing
  Group:
  Data: <i>Keywords: </i>Community child health; Delivery of Health Care, Integrated; Developmental neurology & neurodisability; MENTAL HEALTH; Randomized Controlled Trial; Social Support
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  Data: <i>Date Created: </i>20260929 <i>Date Completed: </i>20260929 <i>Latest Revision: </i>20260930
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  Data: 20261001
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  Data: 10.1136/bmjopen-2026-122902
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  Data: 42810805
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cmedm&AN=42810805
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        Value: 10.1136/bmjopen-2026-122902
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      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: e122902
    Subjects:
      – SubjectFull: Child, Preschool
        Type: general
      – SubjectFull: Female
        Type: general
      – SubjectFull: Humans
        Type: general
      – SubjectFull: Infant
        Type: general
      – SubjectFull: Australia
        Type: general
      – SubjectFull: Health Services Accessibility
        Type: general
      – SubjectFull: Research Design
        Type: general
      – SubjectFull: Randomized Controlled Trials as Topic
        Type: general
      – SubjectFull: Caregivers psychology
        Type: general
      – SubjectFull: Child Health Services organization & administration
        Type: general
      – SubjectFull: Parents psychology
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      – SubjectFull: Child Development
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      – TitleFull: Effect of strengths-based, tiered, accessible resources and supports (STARS) for Kids project, a codesigned hybrid service delivery framework to identify and support child development, parent mental health and psychosocial needs among parents and carers of children aged 6 months to 3 years: a randomised controlled trial protocol.
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            – D: 29
              M: 09
              Text: 2026 Sep 29
              Type: published
              Y: 2026
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              Value: 2044-6055
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