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.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