Early Life Cohort Feasibility Study (ELC-FS)

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We have brought together a multidisciplinary team across the four nations of the UK with deep scientific and operational expertise, to deliver a feasibility study of recruitment into a new early life cohort for the UK. Our major aim is to provide proof of concept for a new birth cohort study that would be scientifically valuable, provides evidence for policy, is operationally feasible and garners strong public support. To achieve this, we will design and undertake a data collection that is of lasting value, informing on key issues facing new generations of babies and their families. Representative sampling and successful recruitment are fundamental foundations required to deliver cutting edge research of this nature. At the heart of this exercise will be a test of our ability to successfully secure access to an appropriate national sampling frame of babies born in each of the four nations, and to devise a sample design and recruitment strategy that maximises participation and representativeness overall, and enables participation among groups that are traditionally seen as 'hard to reach' in longitudinal population research. This will include oversampling of ethnic minorities and births in deprived areas. We will engage fathers, including those non-resident at birth. We will bring together experts to discuss the potential for a study of children in need. The feasibility study will be designed to develop and test a protocol of high-quality measurements of early child development and the multilevel social and biological processes that affect early developmental outcomes, using both tried-and-tested instruments and newly-emerging technologies. We will deploy a variety of modes and methods of data collection, including an in-person home visit, data collection via devices (including to capture sleep and activity level), and by smartphone app (to capture infant-parent interactions, developmental milestones, diet and momentary assessments of parental stress). We will test how collection of bio-samples, including buccal swabs, saliva, and hair, from infant and parents would impact participation in the study, via a randomised experiment. We will develop a strategy for linking electronic health and other administrative records, as well as geo-environmental data, which will form a central part of any future study. In addition to providing rigorous testing of a scientific protocol in preparation for the main-stage study, the data we will collect in this feasibility study will be of great value for scientists and policy makers interested in infant health and development. We will undertake careful public engagement to ensure public acceptability of the proposed sampling, data collection and record linkage approaches, and will ensure the study serves the needs of the people it represents, by working closely with panels of families and children. We will engage closely with policy and practitioner networks and will consult with academic data users to determine evidence needs and scientific priorities for the feasibility study. An evaluation phase at the end of the project will support decision taking on whether a main study is commissioned. The project team will provide methodologically robust evidence on an agreed set of outcomes to inform this decision. Our team is uniquely experienced and well placed to deliver this ambitious project, combining expertise in the leadership and operations of longitudinal studies, the science of early life, sample frames and record linkages relating to babies in each of the four UK nations, collecting bio-samples from infants and parents, statistical methods, public engagement, and engagement of fathers in longitudinal research. Further collaborators and partners in the project provide deep expertise on sample design, looked after children and children in need, engaging with families and children, policymakers and practitioners, and international harmonisation.