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.

Study Overview

• Status: Completed
• Conditions: Mothers Who Have Been Referred for Parenting Support
• Intervention / Treatment: Behavioral: Mellow Babies

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lisburn, United Kingdom, BT28 1LU
    • Lisburn Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mellow Babies; Mellow Babies is a group day programme, run one day a week over 14 weeks with a joint focus on maternal wellbeing and the parentinfant interaction: transport and crèche facilities are provided.The focus is to: (a) explicitly enhance close mother-infant attunement, using a combination of baby-massage, interaction coaching and infant focussed speech; and (b) offer mothers support for their own distress. 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.	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.; Other Names: Mellow Parenting
No Intervention: Care as Usual; Routine care received by 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: South Eastern Health and Social Care Trust
• Investigators: Principal Investigator: Lucy Thompson, BA PhD MPH, University of Aberdeen

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 24, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Mental Health; Parenting; Pilot study; Paediatrics; Randomised Controlled Trial
• Other Study ID Numbers: 2/033/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO