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Completed

NCT Number: NCT02277301

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.

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Key information

Conditions

Mothers Who Have Been Referred for Parenting Support Behavior Personal Satisfaction Psychological Well-Being

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lisburn Health Centre

Lisburn, BT28 1LU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mellow Babies

Behavioral

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 names: Mellow Parenting

Primary outcomes

  1. Mellow Parenting Observation System (MPOS).

    Time frame: 16-18 weeks

    MPOS, is an event sampled observational system in which the rate of positive and negative parenting behaviours is calculated.

Secondary outcomes

  1. The Adult Wellbeing Scale (Snaith et al 1978)

    Time frame: 16-18 weeks

    The Adult Wellbeing Scale is based on the Hospital Anxiety and Depression Scale which is used to determine the levels of anxiety and depression that a patient is experiencing.

Other outcomes

  1. The Edinburgh Postnatal Depression Scale (Cox et al 1987) -

    Time frame: 16-18 weeks

    The Edinburgh Postnatal Depression Scale is the standard clinical screening tool for postnatal depression, widely used by health visitors.

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • South Eastern Health and Social Care Trust

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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