Conducting a large-scale randomised controlled trial in children’s social care: reflections on challenges, successes and lessons learned from the Reflective Fostering Study

Background

Research in Children’s Social Care in the UK operates in a framework initially designed to support medical research within health 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 clinical trials (RCTs) in fostering services in the UK 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 lack the infrastructure to support it.

Objective

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 describe how those working on this research project came together to adapt the existing systems and processes and overcome the challenges.

Design

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

Setting and participants

Local Authority and Independent Fostering services in the UK. 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.

Results

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 was proportionate and the workload for our sites was minimised. Identifying likely departments to obtain key approvals, working with local Clinical Research Networks (CRNs) and providing templates made the site set up process faster and supported recruitment.

Limitations

The challenges reported were those encountered by a study that took place in fostering services in the UK. The challenges faced, and solutions identified, may not be mirrored in other sectors of children’s social care, or other countries, where the framework supporting research is different.

Conclusions

Carrying out high-quality clinical trials within fostering services in the UK 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. On-going 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 whilst upholding safeguarding. Without doing so, high-quality clinical trials within fostering services in the UK 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.

Future work

Based on our experience with this RCT, we encourage other research teams to use some of the pragmatic suggestions set out in this paper and evaluate whether they impact on their ability to conduct high-quality clinical trials within fostering services in the UK. 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