Condition category
Not Applicable
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
29/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Child abuse and neglect is a major public health problem and infants are a high-risk group accounting for up to 13% of child protection registrations in the UK, and a significant number of deaths. The provision of sensitive caregiving during the first few years is important because brain development is rapid at this time, but also very vulnerable to negative influences. A nurse home visiting programme, Family Nurse Partnership (FNP) which starts early in pregnancy and extends until infants are 24 months old has been identified as one with strong evidence that it reduces the later risk of child abuse. It is now offered widely in England but is only available to first-time mothers under 20. Group Family Nurse Partnership (gFNP), a newly developed programme, based on the FNP curriculum and strength-based approach, is delivered in a group context to 8-12 women with similar expected delivery dates, starting in pregnancy and lasting until infants are 12 months old. Partners are also encouraged to attend the group sessions. Following the success of group-based antenatal care such as the US Centering Pregnancy Model, preferred by many to traditional care and leading to improved prenatal outcomes among high-risk women, the gFNP programme combines the provision of the FNP curriculum with midwifery care in pregnancy and infant health checks in infancy. Women are encouraged to monitor their own health. The aim of this study is to examine if provision of the gFNP programme, compared to routine antenatal and postnatal services, can reduce risk factors for maltreatment.

Who can participate?
The gFNp programme is being offered in England to women currently not eligible for FNP but who are likely to benefit from the support, namely in expectant mothers <20 years with one or more previous live births or expectant mothers aged 20-24 with low/no qualifications and no previous live births. Ideally they will recruit when they are between 12 and 16 weeks gestation.

What does the study involve?
After initial identification by community midwifery in pregnancy, informed consent will be gained by a local researcher in the participant's home and participant will complete an interview. Participants will then be randomly allocated either to receive the gFNP programme or routine antenatal and postnatal services. Those receiving gFNP will take part in up to 44 gFNP sessions, each lasting approximately 2 hours and delivered in a local centre by two specially trained Family Nurses, one of whom is also a registered midwife. All study participants will be visited by a researcher in their home when infants are 2 and 12 months of age, with an additional telephone research contact when infants are 6 month old.

What are the possible benefits and risks of participating?
There will be potential benefits for the study participants whether they receive the programme or not. They will experience three research visits, with a small monetary reward, plus one additional telephone contact, and will be able to talk about their parenting experiences. Any family thought to be in need of referral to specialist services will be urged by the research team to do this, through their general practitioner (GP) and will be supported by the researchers. There are no obvious risks of participating. While some expectant mothers will not receive the programme under investigation it is first important to investigate whether the program under investigation has a beneficial impact.

Where is the study run from?
The First Steps Study has been set up by Birkbeck, University of London with collaboration from the London School of Hygiene and Tropical Medicine, the University of Warwick, Queen's University Belfast and the University of Nottingham.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in mid 2013, extending over 6 to 7 months and taking place in 6-7 locations throughout England. Each location will offer the programme to two groups, with start times approximately 3 months apart. Participants will be enrolled in the study for 20 months. Given the phased nature of enrolment and programme delivery, from the start of recruitment the entire study will extend over 30 months.

Who is funding the study?
National Institute of Health Research (UK).

Who is the main contact?
Prof Jacqueline Barnes
Jacqueline.barnes@bbk.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jacqueline Barnes

ORCID ID

Contact details

Institute for the Study of Children
Families and Social Issues
Birkbeck
University of London
Malet Street
London
WC1E 7HX
United Kingdom
-
Jacqueline.barnes@bbk.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14520

Study information

Scientific title

FIRST STEPS: Randomised controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) programme compared to routine care in improving outcomes for high risk mothers and preventing abuse

Acronym

FIRST STEPS

Study hypothesis

Child abuse and neglect is a major public health problem and infants are a high-risk group accounting for up to 13% of child protection registrations in the UK. The provision of sensitive caregiving during the first few years is important because brain development is rapid at this time. A nurse home visiting programme, Family Nurse Partnership (FNP) which starts early in pregnancy and extends until infants are 24 months old has been identified as one with strong evidence that it reduces the later risk of child abuse. In England it is only available to first-time mothers under 20. Group FNP, a newly developed programme, based on the FNP curriculum and strength-based approach, is delivered in a group context to 8-12 women with similar expected delivery dates, starting in pregnancy and lasting until infants are 12 months old. Partners are also encouraged to attend the group sessions. The gFNP programme combines the provision of the FNP curriculum with midwifery care in pregnancy and infant health checks in infancy. Women are encouraged to monitor their own health. The aim of this study is to examine if provision of the Group Family Nurse Partnership (gFNP) programme, compared to routine antenatal and postnatal services, can reduce reduce risk factors for maltreatment.

After initial identification by community midwifery in pregnancy, informed consent will be gained by a local researcher in the participant's home and a baseline interview completed. Participants will then be randomly assigned either to receive the gFNP programme or routine antenatal and postnatal services. All study participants will be visited by a researcher in their home when infants are 2 and 12 months of age, with an additional telephone research contact when infants are 6 month old.Those receiving gFNP will take part in up to 44 gFNP sessions, each lasting approximately 2 hours.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14520

Ethics approval

NRES Committee South West - Frenchay, 28/05/2013, REC number 13/SW/0086

Study design

Randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Dr. Jane Stuart, Trial Manager, j.Stuart@bbk.ac.uk to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Disease: All Diseases

Intervention

1. Group Family Nurse Partnership, Delivered by two Family Nurses one is also a qualified midwife. The group consists of between 8 and 12 women with EDDs within 6 weeks of each other, and partners are encouraged to attend. Routine midwifery care in pregnancy and infant health checks in infancy according to NICE guidelines are undertaken during the gFNP session with encouragement for mothers to conduct the necessary checks themselves. Groups meet from 16 weeks pregnancy until infants are 12 months old (total of 44 sessions).

2. Usual antenatal and postnatal services.

Follow Up Length: 18 months
Study Entry : Single Randomisation only

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

Adult Adolescent Parenting Inventory (AAPI-2); Timepoints: Baseline (10-14 weeks gestation) and 18 months later when infants are 12 months

Secondary outcome measures

1. CARE index; Timepoints: Infant 12 months
2. Edinburgh Postnatal Depression Scale; Timepoints: baseline (10-14 weeks gestation), infant 2 months, infant 6 months, infant 12 months
3. EQ-5D 5L quality of life; Timepoints: Baseline (10-14 weeks gestation), infant 2 months, 6 months, 12 months
4. Medical Outcomes Study (MOS) social networks measure; Timepoints: Baseline (10 to 14 weeks gestation) and infant 12 months
5. Parenting Stress Index (short form); Timepoints: Infant 2 months and infant 12 months
6. Perceived Parenting Competence (PSOC); Timepoints: Infant 2 months, infant 12 months
7. Service use; Timepoint(s): Infant 2 months, 6 months and 12 months

Overall trial start date

01/02/2013

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged <20 with one or more previous live births, or
2. Aged 20-24 with low/no educational qualifications and no previous live births.

Low educational qualifications is defined as not having both Maths and English GCSE at grade C or higher or, if they have both of these GCSEs, no more than 4 GCSEs in total at grade C or higher.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

UK Sample Size: 200; Description: 100 intervention participants and 100 controls

Participant exclusion criteria

1. Expectant mothers who have previously received home-based FNP
2. Expectant mothers with psychotic mental illness
3. Expectant mothers who are not able to communicate in English.

Recruitment start date

22/07/2013

Recruitment end date

23/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for the Study of Children, Families and Social Issues
London
WC1E 7HX
United Kingdom

Sponsor information

Organisation

University of London (UK)

Sponsor details

Institute for the Study of Children
Families and Social Issues
Birkbeck
University of London
Malet Street
London
WC1E 7HX
United Kingdom

Sponsor type

University/education

Website

http://www.bbk.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) ref: PHR 11/3002/02

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24011061

Publication citations

  1. Protocol

    Barnes J, Aistrop D, Allen E, Barlow J, Elbourne D, Macdonald G, Melhuish E, Petrou S, Pink J, Snowdon C, Spiby H, Stuart J, Sturgess J, First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse., Trials, 2013, 14, 285, doi: 10.1186/1745-6215-14-285.

Additional files

Editorial Notes