Clinical trial NCT02277301: Mellow Babies - a Pilot Waiting List Trial
Official title: Mellow Babies - a Pilot Waiting List Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mothers Who Have Been Referred for Parenting Support
Keywords: Pilot study
Randomised Controlled Trial
Parenting
Paediatrics
Mental Health
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: South Eastern Health and Social Care Trust
First posted: 2014-10-29
Enrollment: 45
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

Mothers of infants aged less then 13 months who have been referred for parenting support by the health or social care services.

Exclusion Criteria:

Those unable to complete research assessments (due to literacy or language issues).

Primary outcomes:
measure: Mellow Parenting Observation System (MPOS).
timeFrame: 16-18 weeks
Secondary outcomes:
measure: The Adult Wellbeing Scale (Snaith et al 1978)
timeFrame: 16-18 weeks
Other outcomes:
measure: The Edinburgh Postnatal Depression Scale (Cox et al 1987) -
timeFrame: 16-18 weeks
Locations:
city: Lisburn
country: United Kingdom
facility: Lisburn Health Centre
Study officials:
affiliation: University of Aberdeen
name: Lucy Thompson, BA PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: