Clinical Research Directory

Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Association With Neonatal and Maternal Outcomes

This study is the first in the United Kingdom (UK) to look at how women and families from different backgrounds use ambulance services during the 'perinatal period' - through pregnancy, birth, and shortly after having a baby. The researchers want to understand whether all women have the same access to urgent and emergency maternity care, and whether there are differences in health outcomes for mothers and babies who use ambulance services. The study has two parts (called Work-Packages): Work Package One will look at data from women who were taken by ambulance to a Manchester University National Health Service (NHS) Foundation Trust (MFT) maternity unit during the perinatal period, compared with those who had a baby at MFT but were not taken there by ambulance. It will look at the differences between the two groups and their health outcomes. Work Package Two will look closely at the text written by paramedics within ambulance records for some women from Work Package One, especially those at increased risk of a poor outcome. The researchers will study what happened during their care journey and look for anything that happens repeatedly within the text to better understand their experiences. By combining the results from both work packages, the study aims to give a detailed picture of how different women access emergency maternity care and outcomes for themselves and their babies. This will help identify ways to improve services, especially for women who may face barriers to getting the care they need, helping to make sure that maternity care is safe, fair, and more effective for everyone.

Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.

The overall aim of this clinical trial is to evaluate an at scale version of 'Happy Talk' in a large scale effectiveness study (examining inputs, outputs and outcomes) based on a sample of children from socially disadvantaged areas. Researchers will compare Happy Talk to usual care and children's allocation to the programme will be decided on randomly. The investigators also aim to * complete a pre-trial process evaluation to inform intervention implementation - examining factors which promote parental engagement and partnership between SLTs and educators and incorporating these into SLT training and future rollouts of the programme. * complete a concurrent process evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context and therefore what would need to be considered for successful implementation across varied settings. Our SWAT is embedded in this process evaluation and addresses the Trials Methodology Research Network methodological priority questions 1 and 5 https://priorityresearch.ie/priority-one-questions/ * Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard pre/school care. The study aims to answer the following research questions: When implemented at scale 1. Does 'Happy Talk', a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children? 2. Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts? 3. What programme features support successful real-world application of 'Happy Talk' including factors which promote parental engagement; partnership between SLTs and educators; and fidelity of implementation? 4. How do contextual factors influence Happy Talk implementation /outcomes? 5. How can trials become part of routine care? 6. Is Happy Talk cost effective compared to usual care? Intervention: The programme is informed by general systems theory and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour. There are both parent and preschool staff components to the programme.