Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Pasco Fearon


Contact details

Gower Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Supporting young mothers (aged 14-25) in the first two years of life: a randomized controlled trial of the NSPCC UK Minding the Baby Home Visiting Programme


Study hypothesis

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk first time mothers aged 14-25 living in poverty. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. The proposed Randomised Control Trial (RCT) will allow for testing the efficacy of this innovative intervention across three UK sites. Participants will be randomly assigned to one of two arms, a treatment arm Minding the Baby (MTB) or a control arm- Treatment as Usual (TAU). Potential participants will be approached by a member of the clinical care team within midwifery who will inform mothers of the project during their booking-in (8-10 weeks) or 20-week scanning appointment. Posters and leaflets will also be placed in antenatal clinics. Consenting eligible participants will be seen by a researcher before they give birth and when their child is one and two years old.

We will be evaluating the effectiveness of the MTB programme by looking at a range of maternal and infant outcomes, including infant attachment security, maternal sensitivity and verified accounts of infant maltreatment and neglect. In addition we will be assessing the cost effectiveness of the MTB programme in order to support future roll-out of services. This study, involving a collaboration between the NSPCC, University College London and three NHS hospitals, affords a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in the UK.

Ethics approval

13/LO/1651; First MREC approval date 16/01/2014

Study design

Randomised; Interventional; Design type: Not specified, Prevention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth


1. Minding the Baby: This is an intensive home visiting intervention in which mothers are visited weekly by a trained practitioner in the first year, and two-weekly in the second.
2. Treatment as Usual: This is usual care received by mothers during their baby's first two years.

Follow Up Length: 12 month(s); Study Entry: Registration and One or More Randomisations

Intervention type



Not Applicable

Drug names

Primary outcome measure

Parental sensitivity; Timepoint(s): 12 months, 24 months

Secondary outcome measures

1. Attachment security; Timepoint(s): 12, 24months
2. Child behavioural problems; Timepoint(s): 24 months
3. Child cognitive/language development; Timepoint(s): 24 months
4. Incidences of child abuse and neglect; Timepoint(s): 12, 24 months
5. Maternal mental health; Timepoint(s): Baseline, 12 and 24 months
6. Postponed childbearing; Timepoint(s): 24 months
7. Service cost evaluation; Timepoint(s): 24 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Primparous
2. Age 19 or under at the baby's conception OR age between 20 and 25 and in receipt of means-tested benefits
Target Gender: Female; Upper Age Limit 25 years ; Lower Age Limit 14 years

Participant type


Age group




Target number of participants

Planned Sample Size: 200; UK Sample Size: 200;

Total final enrolment


Participant exclusion criteria

1. Mothers with a psychotic illness
2. Substance abuse disorders/chronic drug dependence
3. Those with profound or severe learning disabilities
4. Those parents with a life-threatening illness
5. Parents whose child is expected to be born with a life threatening illness or profound disability
6. The mother has been screened for participation in a Family nurse Partner Service (See A-29)
7. Non-English speaking

These exclusions have been made because families need to be able to understand and give informed consent, participate in treatment, and understand and complete all research questionnaires and assessments. Not all clinicians providing the interventions for the study are able to work with interpreters when working with non-English speaking families. Also, most of the research instruments have not been validated in other languages. The programme is believed to be inappropriate for mothers with very severe mental illness or substance abuse disorders.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name


Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

2019 results report in (added 25/06/2020)

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 protocol in:

Publication citations

Additional files

Editorial Notes

25/06/2020: Link to results report added to publication and dissemination plan. 21/06/2019: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/04/2014 to 14/04/2014. 2. The recruitment end date was changed from 28/02/2015 to 30/03/2016. 3. The total final enrolment was added. 10/10/2016: Publication reference added.