Mellow Babies - a Pilot Waiting List Trial

Mothers Who Have Been Referred for Parenting Support Clinical Trial

Official title:

Mellow Babies - a Pilot Waiting List Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277301
• Other study ID #: 2/033/14
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: April 2019
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mothers Who Have Been Referred for Parenting Support

Intervention

Behavioral:
• Mellow Babies
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.

Locations

Country	Name	City	State
United Kingdom	Lisburn Health Centre	Lisburn

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	South Eastern Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Edinburgh Postnatal Depression Scale (Cox et al 1987) -	The Edinburgh Postnatal Depression Scale is the standard clinical screening tool for postnatal depression, widely used by health visitors.	16-18 weeks
Primary	Mellow Parenting Observation System (MPOS).	MPOS, is an event sampled observational system in which the rate of positive and negative parenting behaviours is calculated.	16-18 weeks
Secondary	The Adult Wellbeing Scale (Snaith et al 1978)	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.	16-18 weeks