Does Mellow Babies improve the psychosocial health of mothers and their children? The Mellow Babies Trial

We aim to assess the effectiveness of the Mellow Babies (MB) programme in promoting maternal mental health and in improving social and emotional wellbeing among children under 18 months. Setting: Highland region of Scotland, including a range of urban, rural, affluent and deprived communities. Participants will be referred by health visitors, social workers, paediatricians and GPs. Mothers scoring above threshold on the Hospital Anxiety and Depression Scale (HADS) when their child is 6 - 18 months old will be invited to participate. We aim to recruit 212 families to ensure evaluable data on 170. If less than 40 participants recruited by month 8, the study will be stopped (stop/go point). Design: randomised controlled trial. MB will be offered to participants in the active arm of the trial, and usual care to both arms. Families will be seen by a research nurse at recruitment and by a research assistant blind to group allocation at 8 months post-randomisation and when children are 30 months old. Intervention: MB addresses maternal wellbeing and parent-infant interaction. It consists of 14 weekly five-hour group sessions plus one reunion: transport, refreshments, and crèche facilities are provided. MB will be delivered by early years workers in community settings. The intervention will be built upon existing services and expertise. Apart from any referrals made by GPs and paediatricians and collection of service use data, NHS staff and premises are not involved. Primary outcome: Maternal HADS total score at 8m post-randomisation and when the child is 30m old. Secondary outcomes at age 30m: children's social and emotional functioning (Total Difficulties scale of the parent-reported Strengths and Difficulties Questionnaire (SDQ)); SDQ subscale scores; expressive language in the 50-word Sure Start Language Measure (SSLM); Bayley III Scales of Infant and Toddler Development including Behavior Observation Inventory, counts of positive and negative parenting behaviours in mealtime videos, within-trial cost analysis of participants' service use and out of pocket expenses, cost-consequence analysis. Secondary outcomes at 8m post randomisation: SSLM, BITSEA, and description of participants' service use and out of pocket expenses. Longer term outcomes will be addressed through use of administrative data and economic modelling. Process evaluation: Quantitative and qualitative research will examine how the intervention is implemented and explore the mechanisms by which it might achieve impact, for whom it seems to work best and contextual factors affecting impact. Timetable: October 2018 to end November 2022 (50 months). Milestones: prefunding: protocol development; research ethics, management approvals; M1-3: study initiation, set up office, assemble team, intervention training. M4-23: recruit 212 participants (11 per month (M8 stop/go point); M16-47 complete follow up to 30 months old; M47-50 close down, analysis and report writing. Expertise: The team has extensive experience of parenting intervention research and of conducting trials with people who may be hard to recruit and retain. We have a strong track record in translating research into policy, conducting robust qualitative evaluations, and long term modelling of outcomes. The trial will be supported by a fully registered UK CRC CTU, with internationally recognised expertise in complex intervention trials.