Mellow Babies RCT

Mellow Babies RCT

Following from the Mellow Babies pilot waiting list trial https://www.abdn.ac.uk/iahs/research/crh/projects/mellow-babies.php we are now embarking on a full RCT.

The Mellow Babies Trial logo

Dates:

01/10/2018 for 50 months

Overview:

Dedicated project website: https://w3.abdn.ac.uk/hsru/MellowBabies/Public/Public/index.cshtml

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 Scientific conferences and events.

Funded by: NIHR - National Institute for Health Research

Collaborating organisations:

  • University of Aberdeen
  • University of Glasgow
  • University of Edinburgh
  • Queens University, Belfast
  • Newcastle University
  • NHS Highland
  • The Highland Council
  • Parenting Across Scotland