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

Background and ObjectivesSelf-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 AnalysisRealist 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 numberThe protocol is registered with Open Science Framework https://osf.io/5ce2z/registrations Strengths and LimitationsO_LIUses a realist approach to provide insight into what works, for whom, under which circumstances, and how for caregiver-mediated interventions designed to promote self-regulation outcomes among infants and young children. C_LIO_LIResearch questions were developed in consultation with families and service providers. C_LIO_LIDecision-making will be transparently documented, and all review materials made available on the Open Science Framework repository. C_LIO_LIThe programme theory will be largely derived from peer-reviewed journal articles, and therefore may be subject to publication bias. C_LI