Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Other
Study 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
Primary outcome measure
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 study start date
15/09/2008
Overall study end date
31/03/2011
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study participating centre
Health Sciences Research Institute
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
University House
Coventry
CV47AL
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/06/2010 | Yes | No | |
| Results article | results | 01/07/2013 | Yes | No |