Mellow Babies - a pilot waiting list trial

Dates:

01/07/2014 to 30/06/2015
Project funding extension agreed to 30/09/2017

Overview:

There is good evidence for the view that early intervention to prevent and manage difficulties in the parent infant relationship may produce long term benefits such as reduction in rates of criminality, substance abuse and educational underachievement.

A meta-analysis of sensitivity and attachment interventions in early childhood has shown that the most effective interventions use a moderate number of sessions (n=516) and are focused on parental sensitivity.

Mellow Babies is an intervention designed for mothers with substantial problems in their relationships with their infants. Typically, participating mothers have mental health difficulties, problem drug use, learning difficulties, forensic issues or they may have children already looked after by the local authority. The intervention consists of 14 whole day sessions with a joint focus on maternal wellbeing and the parent infant interaction: transport and crèche facilities are provided.

Although Mellow Parenting interventions (Mellow Babies is probably the best evidenced) are quite widely used in a number of countries, no definitive randomised trials have been carried out. To date there has been a single small waiting list trial (17 participants) suggesting improvement in maternal mood and mother child interaction.

We aim to inform the design of a definitive RCT with a mixed methods approach, including a pilot waiting list control trial to allow a more robust assessment of effect size on the main outcome measure, and qualitative feedback from participants and practitioners.

This is a mixed methods study centred on a prospective randomised open label blinded endpoint (PROBE) pilot clinical trial with a waiting list control group. The study will be conducted in three areas of Northern Ireland: Lisburn, North Down & Ards, and Downpatrick.

Mellow Babies has been extended to allow for further recruitment of mothers and babies into the trial. There is strong commitment from the South Eastern Health and Social Care Trust and the local Research and Development Management to support this. We are entering our third round of recruitment into intervention groups in September and control groups early next year.

There is also further work being done on the Mellow Parenting Observation System to simplify it as a coding tool for research purposes. This is in its early stages.

Aims

• To identify the strengths and weaknesses of conducting a Randomised Controlled Trial of Mellow Babies.
• To identify what sample size will be required to adequately power a definitive RCT of Mellow Babies.
• To evaluate the study’s potential for success.

Research questions:

Do participants and practitioners perceive Mellow Babies to be feasible and useful in improving mother baby interaction, their sense of wellbeing and parenting self-efficacy?

Does participation in Mellow Babies provide improvements in mother’s wellbeing and sense of parenting self-efficacy at post intervention?

Does participation in Mellow Babies provide improvements in the quality of mother infant interaction at post intervention?

Project publications:

Progress and findings from the study will be publicly available by using open access publishing, there will be updates via this website, and the final report will be available on this site and via the Mellow Parenting website.

Presentation:

• The Mellow Babies trial has now finished and preliminary results have been presented in Northern Ireland at the event on 28^th September 2016:
• Baby Matters – Does a Mellow Parenting Programme delivered locally help?
• This was an opportunity to for policymakers, practitioners and parents to hear about what happened during this pilot Randomised Controlled Trial of a Mellow Parenting programme. We presented:
  • Information about the programme itself
  • What happened during the pilot study 
  • What it was like for the Mums going through the programme and
  • What the data could tell us about the programme’s usefulness to these families
• Photograph from the presentation:
  • Left to right: Alan McMaster, Martin Devlin, Lucy Thompson and Gerry King

Further analysis, writing and publications are now underway.

Involved Partners (and Institutions):

South Eastern Health and Social Care Trust.

Funder:

A Research award from the Infant Mental Health Research Fund (Endowment) at the Royal Hospital for Sick Children, Yorkhill.

Contact information:

Gerry King | +44 (0) 1463 255895 | gerry.king@abdn.ac.uk