Caregiver-mediated interventions to support self-regulation among infants and young children (0-5): A protocol for a realist review

Background and Objectives Self-regulation is a modifiable protective factor for lifespan mental and physical health outcomes. Early caregiver-mediated interventions to promote infant and child regulatory outcomes prevent long-term developmental, emotional, and behavioural difficulties and improve outcomes such as school readiness, educational achievement, and economic success. To harness the population health promise of these programmes, there is a need for more nuanced understanding of the impact of these interventions. The aim of this realist review is to understand how, why, under which circumstances, and for whom, early caregiver-mediated interventions improve infant and child self-regulation. The specific research questions guiding this review were based on consultation with families and community organizations that provide early childhood and family services. Design, Methods and Analysis Realist reviews take a theory-driven and iterative approach to evidence synthesis, structured around continuous refinement of a programme theory. Programme theories specify context-mechanism-outcome configurations to explain what works, for whom, under which circumstances, and how. Our initial programme theory is based on prior work in this field and will be refined through searching peer-reviewed and grey literature to identify relevant evidence. A working group, comprising service users, community organization representatives, representatives from specific populations, clinicians, and review team members will be formed to guide the evidence synthesis and interpretation, as well as the development and dissemination of recommendations based on the findings of the review. The review will involve searching: (1) electronic databases (e.g. EMBASE, Medline, PsycInfo), (2) connected papers, articles and citations, and (3) grey literature. Decisions to include evidence will be guided by judgements about their contribution to the programme theory and will be made by the research team, with input from the working group as required. Evidence synthesis will be reported using the RAMESES guidelines and disseminated through peer-reviewed publication. Trial registration number The protocol is registered with Open Science Framework Strengths and Limitations ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Project staff are supported by funding from the NHMRC FASD Centre of Research Excellence. AFJ is supported by a fellowship from the Starlight Childrens Foundation. No funder played any role in developing the review protocol. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: N/A (review protocol) All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Review documents will be made publicly available on OSF