Conducting a large-scale randomised controlled trial in children's social care: reflections on challenges, successes...

Research in Children's Social Care in the United Kingdom operates in a framework that was initially designed to support medical research within healthcare settings. Although adaptations to this framework have been made for social care settings, our experience suggested that significant systemic and organisational challenges to conducting large-scale randomised controlled trials in fostering services in the United Kingdom still remain, which work against the likelihood of such studies being completed successfully. A further challenge we faced was that that many fostering services were relatively inexperienced with research and lacked the infrastructure to support it.

To report on the opportunities, obstacles and challenges faced when conducting a trial evaluating foster care support in a children's social care setting and to describe how those working on this research project came together to adapt the existing systems and processes and overcome the challenges.

The Reflective Fostering Study was a randomised controlled trial evaluating an intervention to help foster carers care for the children they look after.

Local authority and independent fostering services in the United Kingdom. The main study recruited 524 foster carers and kinship carers. The main study was evaluating the Reflective Fostering Programme, a group intervention designed to improve reflective functioning in foster and kinship carers.

The main challenges identified in this study were lack of infrastructure, both within fostering organisations and outside, a lack of capacity, and on occasion, unnecessary bureaucracy. Working with fostering sites, the Clinical Research Network and across collaborating partners, we were able to make changes to existing processes so that the governance and oversight of the study were proportionate and the workload for our sites was minimised. Identifying likely departments to obtain key approvals, working with local Clinical Research Networks and providing templates made the site set-up process faster and supported recruitment.

The challenges reported were those encountered by a study that took place in fostering services in the United Kingdom. The challenges faced, and solutions identified, may not be mirrored in other sectors of children's social care, or other countries.

Carrying out high-quality clinical trials within fostering services in the United Kingdom can face significant barriers. There has been a move to address these issues, but our study suggests that more could be done so that research in these settings increases. Ongoing review of the regulatory framework, which is designed to ensure best practice for research in children's social care, could ensure that research governance is proportionate while upholding safeguarding. Without doing so, high-quality clinical trials within fostering services in the United Kingdom may face significant barriers. In the meanwhile, certain pragmatic steps can be taken by teams doing studies similar to ours, which can help to overcome some of the challenges faced.

Based on our experience with this randomised controlled trial, we encourage other research teams to use some of the pragmatic suggestions set out in this paper and evaluate whether these impact on their ability to conduct high-quality clinical trials within fostering services in the United Kingdom. If further review or changes are made to the research governance framework, we encourage researchers to evaluate and report on the impact this has on the process of conducting studies in children's social care.

This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR127422.