‘Right from the Start’ a pilot study for a randomized controlled trial of the New Baby Programme for improving outcomes for children born to socially vulnerable mothers

This pilot study is designed to ensure the successful conduct of a full-scale randomised trial capable of comparing the effectiveness of the New Baby Programme with standard antenatal and postnatal care for mothers whose social circumstances are complex. Consenting women up to 20 weeks gestation are randomly assigned either the New Baby Programme or standard care, after the collection of baseline information and using a central computer randomisation programme to ensure allocation concealment. Researchers are blind to each woman’s group assignment. The primary outcome at 12 months is secure attachment assessed using the Strange Situation and CARE-Index (based on a video-taped interaction between parents and infants). Secondary outcomes are abusive parenting, maternal depression, parenting stress, health-related quality of life, social support and use of services.