Randomised controlled trial (RCT) and economic evaluation of the Family Links Nurturing Programme
| ISRCTN | ISRCTN13919732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13919732 |
| Secondary identifying numbers | LOC2549T |
- Submission date
- 23/07/2008
- Registration date
- 30/09/2008
- Last edited
- 28/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Sarah Stewart-Brown
Scientific
Scientific
Health Sciences Research Institute
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 574510 |
|---|---|
| sarah.stewart-brown@warwick.ac.uk |
Study information
| 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 |
| Scientific title | Promoting health and wellbeing with the Family Links Nurturing Programme (FLNP) in South Wales: a randomised controlled trial and economic evaluation |
| 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). |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 288 |
| Participant inclusion criteria | Parents of children aged 2 - 4 years old in children centre areas in Cardiff, Newport and Torfaen in South Wales |
| 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
CV4 7AL
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
University House
Coventry
CV47AL
England
United Kingdom
| Website | http://www.warwick.ac.uk |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Cardiff County Council (UK) (ref: LOC2549T)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
Editorial Notes
28/08/2018: Publication reference added.
