Title: Does "Mellow Babies" improve the psychosocial health of mothers and their children? The Mellow Babies Trial
Funder: Chief Scientist Office, Scotland

Abstract: 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.

Lay abstract: In this research project we wish to find out how well a programme called Mellow Babies (MB) improves mothers’ mental health and the wellbeing of their young children. Previous research has shown that it is important to provide help and support when children are young. This is before problems grow and have knock-on effects for children’s learning and long term wellbeing. Mellow Babies (MB) is a group for mothers who are struggling in their relationship with their baby. The groups look at mothers’ feelings of wellbeing (happiness and sadness/feeling hopeless or not being able to cope as well as the mother used to). It also looks at the way mothers talk to and behave with their baby. MB aims to improve both of these things. The group meets for 14 five-hour sessions, and then for one follow-up reunion session. MB includes transport and child care. The group leaders for MB can be anyone who has some experience of giving help and support for parents of young children. They will be trained in MB and can run groups in local community venues, like village halls or libraries. The research will take place in the Highland region of Scotland, which includes a mixture of large towns, small villages and countryside homes, and a mixture of financial backgrounds. Health visitors, social workers, paediatricians and GPs will be asked to suggest mothers who might like to take part in the research. These can be mothers of children aged 6-18 months who are having problems with wellbeing and their relationship with their baby. Mothers scoring highly on a questionnaire measuring anxiety and depression will be invited to take part. All mothers taking part will receive the care they usually would, and half will also be picked at random to take part in MB. This allows the research team to compare the outcomes for mothers who have had MB with those who haven’t. Families will be seen by a research nurse at the start of their time in the study and by a research assistant 8 months into the study and when children are 30 months old. We aim to recruit 212 families to the study to ensure we have full data on 170. If we are not able to recruit 40 mothers after five months we will stop the study. The main outcome we will measure is mothers’ mental health, using a questionnaire measuring anxiety and depression. Children’s social and emotional wellbeing will be measured by a questionnaire with mothers when the child is 30 months old. We shall also ask mothers about how many words their child uses, directly observe the child carrying out a range of tasks to assess their development, and look at positive and negative parenting behaviours in a video recording (if mothers agree). Finally we shall ask mothers about their experience in the MB groups. Through speaking with mothers and by looking at the results of the study we shall examine how well the MB groups are carried out and the ways that it affects the participants. We shall also collect data that helps us understand whether Mellow Babies offers better value for money than usual care. We shall ask 10-15 mothers to form an advisory group to help us plan the study and communicate the results. This group will put forward two members to join the committee that oversees the management of the trial and will advise on the written information we give to mothers. We shall write reports for publication in scientific journals and present the results at conferences and public events.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH