Securing the future of child health and development: evaluating what works in the early years using a novel interventional family cohort study.

The first three years of childhood provide the building blocks for a child's future, with research consistently showing the long lasting impact of these foundational years on a child's development. The interactions that a parent has with their child in the early years can influence a variety of things later on in life, including a child’s health, educational attainment, and socioemotional wellbeing [1, 2].

Investing in the early years of a child's life is therefore morally and economically crucial. Providing early intervention and support to parents early on in their child’s life could be a window to prevent difficulties with child health and development later on [3]. 

If we understand how important it is to invest early, how should we best use our resources to do so? 

One such way is a ‘proportionate universal’ approach; which means providing support for all children, whilst also giving extra support to those who need it the most. This creates a foundation that reaches every child, regardless of their background or risk factors. This proactive approach aims to prevent problems in outcomes like health, education, and socioemotional wellbeing, before they even start. This proportionate universal approach could help to address potential concerns early on, setting the stage for a society where every child has the opportunity to thrive [4].

Even though it's clear that helping parents early on is a good idea, we don't have enough research evidence on what support and interventions might work best for parents in the first crucial years of their child's life [5, 6]. We need more thorough studies to investigate different ways of supporting parents during this crucial period, making sure they have access to the best support and interventions as needed.

How can we evaluate what works in the early years? Introducing a novel interventional family cohort study

Birth cohorts typically recruit families during pregnancy and follow their health and development over time. The Born in Bradford’s Better Start (BiBBS) cohort is the first of its kind, combining the recruitment of families during pregnancy, with consent for biological samples, and for linking data from routine health and education records for both the mother and child. Crucially, BiBBS participants give their consent for researchers to access data from the delivery of early-years interventions through the Better Start Bradford initiative. The UK’s Big Lottery funded the ‘A Better Start’ initiative to improve the life chances of babies and young children living in some of the poorest parts of England, with Better Start Bradford allocated just under £49 million to implement 22 interventions in three inner city areas of Bradford [7].

The BiBBS cohort recently recruited their 5000th baby, and the team have successfully recruited over half of the eligible pregnant population so far  [8].  

Figure 1: A BiBBS family at the first BiBBS birthday party

How can we make the most of the information we collect in the BiBBS cohort and Better Start Bradford programme to evaluate the effectiveness of early years interventions? A Randomised Control Trial (RCT) is a type of study design where participants are randomly allocated to receive an intervention, or to not receive an intervention (also known as the control group). Whilst RCTs are considered the ‘gold standard’ method for evaluating whether interventions work, they may not always be practical for evaluating interventions in real-world settings. In the context of BiBBS and Better Start Bradford, a traditional RCT method would mean changing how they deliver their service. An RCT could also lose contact with a high number of participants, meaning we would not be able to understand the potential long-term effects of the interventions. In response to this challenge, our team at the Better Start Bradford Innovation Hub and Best Start Steering Group are strategically planning a series of pragmatic evaluations for the delivered interventions. 

‘Pragmatic’ Randomised Trials

We are conducting a pragmatic randomised control trial of the midwife-led continuity of care model, which offers flexible and relational care from a small team of midwives. Midwifery services agreed to embed randomisation at the time of referral to midwifery service, with randomisation embedded into the usual maternity service process. This evaluation will have links to long-term outcomes collected routinely and recorded in health records, reducing the possibility of losing participants in a follow-up period. 

We are also testing the feasibility of embedding a randomised control trial within the BiBBS cohort, using a study design known as a ‘Trial within a Cohort Study’ (TwiCS). The intervention is the Incredible Years Toddler parenting programme, which is a universally available parenting programme based on social emotional learning theory for parents of children aged 1-3-years-old. Unlike traditional randomised trials, a TwiCS introduces a random selection process where individuals enrolled in a cohort are offered the intervention, and their outcomes are compared to those not selected. 

Quasi-experimental effectiveness studies

We are also conducting two studies which will use statistical methods to compare an intervention group to a control group, without randomly allocating participants. The programmes being evaluated in this way are the Baby Steps programme (a universally available antenatal and postnatal parenting intervention, with a targeted element to reach those who need it most) and the Incredible Years Toddler parenting programme (a universally available parenting programme based on social emotional learning theory for parents of children aged 1-3-years-old) [9, 10]. 

These studies are known as ‘quasi-experimental’; because the design does not randomly allocate participants to groups. Instead, intervention participants enrolled in BiBBS will be compared to a control group participant that is demographically similar to them using the ‘propensity score matching’ method. Again, these studies will use long-term outcomes that are collected routinely and recorded in health records. The findings of this evaluation will reflect real world practice, as the services did not have to alter their delivery in any way. 

Figure 2: an illustration of the ‘propensity score matching’ statistical method to conduct the quasi-experimental evaluations. In propensity score matching, parents in the intervention group are matched with a demographically similar parent who had not taken part in the intervention. 

These planned studies of both universal and targeted interventions for parents of young children will tell us what works best to support parents in the early years of their child’s life. This could create a better ‘proportionate universal’ approach to support parents of young children, and improve the livelihoods of children for generations to come.

Acknowledgements

Thank you to all Born in Bradford staff, the Better Start Bradford partnership and staff, all Better Start Bradford project teams, health professionals, local authority and voluntary and community sector organisations who have supported the integration of research into practice. We are grateful to all the families taking part in BiBBS and all members of the Community Research Advisory Group. 

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