NCT02277301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

October 24, 2014

Last Update Submit

April 16, 2019

Conditions

Mothers Who Have Been Referred for Parenting Support

Keywords

Pilot studyRandomised Controlled TrialParentingPaediatricsMental Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Adult Wellbeing Scale (Snaith et al 1978)

    16-18 weeks

Other Outcomes (1)

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

    16-18 weeks

Study Arms (2)

Mellow Babies

EXPERIMENTAL

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

Care as Usual

NO INTERVENTION

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.

Interventions

Mellow BabiesBEHAVIORAL

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.

Also known as: Mellow Parenting
Mellow Babies

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lisburn Health Centre

Lisburn, BT28 1LU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38790505DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Lucy Thompson, BA PhD MPH

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

October 24, 2014

First Posted

October 29, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)