Mellow Babies - a Pilot Waiting List Trial
Condition: Mothers Who Have Been Referred for Parenting Support
Study type: Interventional

Summary: 
      This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint
      (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in
      three areas of Northern Ireland: Lisburn, North Down & Ards, and Downpatrick. At least 50
      women with infants under 13 months old will be recruited during August/September 2014.
    

Detailed description: 
      Psychologically informed very early intervention programmes across the ante- and postnatal
      period have shown promise in delivering cost-effective long term positive outcomes. There is
      robust support 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=5-16) and are focussed on parental
      sensitivity.

      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 suggesting improvement in
      maternal mood and mother-child interaction, We aim to inform the design of a definitive RCT
      with a waiting-list control trial with adequate power to estimate an effect size.

      This is a parallel randomised open-label blinded end-point (PROBE) clinical trial with a
      waiting-list control group. The study will be conducted in three areas: Lisburn, North Down &
      Ards, and Downpatrick. At least 50 women with infants under 18 months old will be recruited
      in September 2014. Participating women will be given information on the study, in particular
      being informed that participation would involve either receiving the intervention the
      following month or after a delay of 20 weeks. Signed consent (which will include consent to
      follow up after one year, beyond the timespan of this study) will be sought after an interval
      of at least 24 hours to allow the women to arrive at an informed decision.
    

Intervention name(s): Mellow Babies
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): Mellow Parenting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pilot study; Randomised Controlled Trial; Parenting; Paediatrics; Mental Health