The Mellow Babies Trial
Research type
Research Study
Full title
Does "Mellow Babies" improve the psychosocial health of mothers and their children? The Mellow Babies Trial
IRAS ID
235070
Contact name
Lucy Thompson
Contact email
Sponsor organisation
University of Aberdeen
ISRCTN Number
ISRCTN47575326
Duration of Study in the UK
4 years, 1 months, 30 days
Research summary
We wish to find out how well Mellow Babies (MB) improves mothers’ mental health and the wellbeing of their young children. MB is a group for mothers of babies aged 6-18 months who are struggling in their relationship with their baby. The groups look at mothers’ feelings of wellbeing and at the way mothers talk to and behave with their baby. The groups meet for 14 five-hour sessions, and then for one follow-up reunion session. Health visitors, social workers, paediatricians and GPs will be asked to suggest mothers who might like to take part in the research. 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.
Families will be seen by a research nurse at the start of their time in the study and by a research assistant 8 months later 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 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. We shall also collect data on value for money.Summary of Results
There are links between mothers’ mental well-being, parenting behaviours and childhood mental health.
Childhood social, emotional and development problems are connected to long-term health problems and other types of adversity, such as poverty and crime. We wanted to examine whether a group-based parenting intervention, ‘Mellow Babies’, would improve mothers’ mental well-being and children’s development and whether it represented value for money.
What did we do?
We aimed to recruit 212 women to take part. Women were eligible if they had a baby aged
6–18 months, lived in the Highland Council area (Scotland) and had moderate to high anxiety and/ or depression symptoms. Half of the women were allocated randomly (like tossing a coin) to attend a 14-week Mellow Babies group alongside usual care, and the other half received usual care only (e.g.
seeing their health visitor or attending a feeding clinic). Outcome data for mothers and babies were collected 8 months after recruitment and when babies were 30 months old. We interviewed mothers attending Mellow Babies groups and group facilitators. We had to pause recruitment for 20 months during the COVID-19 pandemic.
What did we find?
We were not able to recruit enough participants: 106 women took part. This means we could not compare the outcomes of mothers and babies who attended the Mellow Babies programme with those who did not or whether it was good value for money. Writing a letter to mothers was the most successful method of recruitment. Participants were generally more well-off than the local population (e.g. income, level of education) but they did experience significant mental ill health. A large proportion of participants stayed in the study until the final follow-up (75%). In interviews, participants highlighted barriers and facilitators of engagement with the intervention groups. Participants recruited before the pandemic were no different from those recruited afterwards.
What did this mean?
We cannot say definitively whether Mellow Babies is effective at improving mothers’ mental well-being or children’s developmental outcomes. A new larger trial is needed, building on the Mellow Babies Trial.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0304
Date of REC Opinion
11 Dec 2018
REC opinion
Further Information Favourable Opinion