Mellow Babies - a Pilot Waiting List Trial

NCT ID: NCT02277301

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-07-31

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.

Conditions

Mothers Who Have Been Referred for Parenting Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mellow Babies

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Mellow Parenting

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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

South Eastern Health and Social Care Trust

OTHER

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Dr Lucy Thompson

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucy Thompson, BA PhD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

Lisburn Health Centre

Lisburn, , United Kingdom

Countries

United Kingdom

References

Thompson L, Wilson P. Mellow Babies: A Randomised Feasibility Trial of an Intervention to Improve the Quality of Parent-Infant Interactions and Parental Mental Wellbeing. Children (Basel). 2024 Apr 24;11(5):510. doi: 10.3390/children11050510.

Reference Type: DERIVED

PMID: 38790505 (View on PubMed)

Other Identifiers

2/033/14

Identifier Type: -

Identifier Source: org_study_id