Mothers Who Have Been Referred for Parenting Support Clinical Trial
Official title:
Mellow Babies - a Pilot Waiting List Trial
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.
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.
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