Condition category
Not Applicable
Date applied
23/07/2008
Date assigned
30/09/2008
Last edited
16/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Stewart-Brown

ORCID ID

Contact details

Health Sciences Research Institute
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 574510
sarah.stewart-brown@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LOC2549T

Study information

Scientific title

Promoting health and wellbeing with the Family Links Nurturing Programme (FLNP) in South Wales: a randomised controlled trial and economic evaluation

Acronym

Study hypothesis

Sub-optimal parenting is a common risk factor for deleterious social educational and health outcomes, increasing the risk of educational failure, delinquency, crime and violence, child and adolescent mental health problems, common mental disorders in adulthood, drug and alcohol misuse and teenage pregnancy. There is also evidence to suggest an effect on physical health throughout the life course. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups (high risk families or those where problems have already occurred) and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP; http://www.familylinks.org.uk/nurturing/index.htm) focuses on family relationships as well as behaviour management and may be better placed to improve educational and health outcomes in the context of universal provisional than the primarily behaviour management programmes. Developed in the UK voluntary sector, FLNP is popular with practitioners in South Wales, has impressed policy makers throughout the UK, evaluates well in before/after and qualitative studies, but lacks an RCT evidence base.

Ethics approval

This study was approved by the NHS South East Wales Local Research Ethics Committee on the 7th October 2008 (ref: 09/WNo01/50).

Study design

Multi-centre, investigator-blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Parenting

Intervention

The participants will be allocated to the intervention and control groups in equal numbers (144 participants in each group).

The FLNP is a ten-week programme involving 2-hour sessions each week for groups of 6-10 parents. The programme is structured and aims to provide experiential knowledge and insight through the use of guided discussion, role play and home work. Parents set targets for themselves each week and report back on progress the following week. The four building blocks of the programme are:
1. Development of self-awareness and self-esteem
2. Appropriate expectations
3. Positive discipline
4. Empathy

The programme is eclectic, drawing on social learning theory and psychotherapeutic insights. It is founded on the belief that empathetic insight into emotional determinants of behaviour is important for both positive relationships and behaviour management. It aims to provide parents with insights into the origins of self-esteem and positive relationships by drawing on their own experiences as children. The programme thus supports parents in improving their own relationships with others as well as with their children. Parents are given a copy of the programme book 'The Parenting Puzzle', and each programme is run by two facilitators who receive face-to-face supervision three times during the course of the programme from an experienced programme facilitator. The capacity to make compassionate relationships with the parents in the groups, to empower and to support them, and at the same time provide a tightly run, structured group programme is seen as essential to success.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

A composite index derived from the following:
1. A parent report measure of parent-child relations
2. Home Observation for Measurement of the Environment (HOME) inventory, recorded during the data collection home visit

The primary outcome measure will be collected immediately before the intervention and 6 months after completing the parenting programme.

Secondary outcome measures

1. To investigate and establish the cost consequences of the FLNP using established economic modelling techniques. The cost consequences will be measured using a cost consequences analysis, which allows an array of outcome measures to be considered alongside the cost of the programme. This will compare FLNP with no intervention in parents and children from public purse, societal and parents' perspectives. Modelling will examine the sensitivity of the results to a range of assumptions. Data will be collected before, during and 6 months after the programme.

2. To investigate the fidelity of programme implementation and delivery by practitioners in Cardiff, Newport and Torfaen. Programme fidelity will be assessed using video recordings of three randomly selected sessions in each programme (with parental consent) coded by Family Links staff. In addition, supervision sessions with the facilitators will be audio recorded and coded by Family Links staff that will also have access to flip chart recordings of changes and insights made by parents during group sessions. Uptake rates, attendance rates (number of sessions attended), drop out rates, mother/father ratio of attendees, attendance and dropout by day and time of group will also be reported.

3. To investigate the views and perceptions of families receiving the FLNP in Cardiff, Newport and Torfaen, including perceived value attributed to the programme. The views and perceptions of families will be gained by interviewing 12 intervention group parents representing different cultural and social backgrounds and different experiences (positive and negative) after the programme to gather information on most and least valued aspects of programme, rating of the facilitators, and ways of improving the programme. We will also ask to interview 12 parents who decline to take part in the study to determine possible ways of improving recruitment.

4. To act at all times in the best interests of children and their families and with due regard to all ethical and legal responsibilities, including Criminal Records Bureau checks for all staff working with children and compliance with the Data Protection Act

Overall trial start date

15/09/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Parents of children aged 2 - 4 years old in children centre areas in Cardiff, Newport and Torfaen in South Wales

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

288

Participant exclusion criteria

Parental age less than 16 years at study entry

Recruitment start date

15/09/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Sciences Research Institute
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

University House
Coventry
CV47AL
United Kingdom

Sponsor type

University/education

Website

http://www.warwick.ac.uk

Funders

Funder type

Government

Funder name

Cardiff County Council (UK) (ref: LOC2549T)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20573236

Publication citations

  1. Protocol

    Simkiss DE, Snooks HA, Stallard N, Davies S, Thomas MA, Anthony B, Winstanley S, Wilson L, Stewart-Brown S, Measuring the impact and costs of a universal group based parenting programme: protocol and implementation of a trial., BMC Public Health, 2010, 10, 364, doi: 10.1186/1471-2458-10-364.

Additional files

Editorial Notes