Condition category
Mental and Behavioural Disorders
Date applied
28/01/2019
Date assigned
27/02/2019
Last edited
04/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Childhood is an important stage of life which has long lasting effects into adulthood. Unfortunately many children now experience emotional and behavioural problems which can lead to problems within their family, school and local communities. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme delivered across the country. This study aims to assess whether the SFSC parenting programme is working in helping those who attend to feel better in themselves, feel less stressed and generally being more able to cope with looking after their families. We will also assess if the programme has an effect on children’s behaviour and well being. The study will take place across 7 urban areas of England where the SFSC programme is offered.

Who can participate?
We are asking parents/carers of children aged 3-18 years who plan to start the SFSC programme to take part in the study. In total 676 parents agreeing to take part will be randomly allocated (like flipping a coin) into two groups: the test group will start the programme immediately, and the control group will start the programme in 10 months time.

What does the study involve?
All the parents agreeing to take part in the study will be interviewed in person or by telephone at the start, after the programme has been completed and then 6 months later. The interviews will each last approximately 30 minutes.

What are the possible benefits and risks of participating?
The results of this project will provide valuable information on whether the SFSC programme is effective in helping parents cope better with looking after their families. All parents involved will be sent a £10 gift token after they complete the 6-month interview as a gesture of thanks for their participation. At the end of the project everyone who has been involved will be sent a summary of the study findings.
Possible disadvantages of taking part in the study include the time involved for the interviews and the potential stress caused by being asked questions about how parents feel about themselves and their family. Every effort will be made to arrange interviews at a convenient time for parents. The interviews will be conducted by skilled and experienced researchers.

Where is the study run from?
The study will run from seven urban areas across England:

• Greater Manchester

• Yorkshire/Humberside (Calderdale; Hull; Kirklees; Leeds; York; Barnsley)

• South London (Lewisham; Lambeth; Southwark; Wandsworth)

• North London (Islington; Brent; Enfield; Barnet)

• West London (Hammersmith and Fulham; Kensington and Chelsea; Ealing; Hounslow)
• East London (Tower Hamlets; Waltham Forest; Hackney; Barking and Dagenham)

• Bristol
The project is being led by University College London.

When is the study starting and how long is it expected to run for?
The study starts on the 1st March 2019 and runs for 48 months ending on the 28th February 2023.

Who is funding the study?
This study is being funded by the National Institute for Health Research (NIHR) – Public Health Research Programme.

Who is the main contact?
Professor Richard Watt, r.watt@ucl.ac.uk

Trial website

To be set up

Contact information

Type

Scientific

Primary contact

Prof Richard Watt

ORCID ID

http://orcid.org/0000-0001-6229-8584

Contact details

Department of Epidemiology and Public Health
UCL
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Together Protocol Version 1 (16/122/35)

Study information

Scientific title

A randomised controlled trial evaluating the effectiveness and cost effectiveness of 'Strengthening Families, Strengthening Communities': a community led parenting programme

Acronym

TOGETHER

Study hypothesis

In an ethnically diverse population of families with children aged 3-18 years living in socially disadvantaged areas across England, does the offer of the Strengthening Families, Strengthening Communities (SFSC) parenting programme compared to waiting list controls significantly enhance parental well-being and child social and emotional well-being?

Ethics approval

Approved 17/02/2019, UCL Ethics Committee (Helen Dougal, UCL Research Ethics Administrator, Office of the Vice-Provost (Research), University College London, 2 Taviton Street, London, WC1H 0BT; 020 7679 8717; ethics@ucl.ac.uk), ref: 1538/002

Study design

Multi-centre wait list controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Parental mental well-being and child socio-emotional well-being.

Intervention

Strengthening Families, Strengthening Communities (SFSC) is a group based universal parenting programme designed to support parents with children aged up to 18 years to improve their well-being, confidence and competence in parenting; develop better relationships with their children; explore strategies to put appropriate boundaries in place; support their children to minimise risky behaviours; and help children transition through childhood to adulthood. In addition, it aims to empower parents to play a more active role in their local communities.

Originally developed in the US, the Race Equality Foundation (an independent charitable community organisation committed to race equality) has adapted the programme for the UK. Since 2000 it has been delivered by family and social care organisations across England. Based upon social learning theory, it uses interactive methods to encourage parents to share their experiences and undertake practical activities to develop their skills, confidence and self-esteem. The 13-week programme is delivered by trained family workers guided by a detailed programme manual and supporting quality assurance resources.

Participants enrolling on the SFSC programmes (n=52 clusters in total) across the 7 areas will be approached to participate in the study, consent sought and agreed, baseline outcome data collected and then individually randomised to intervention or waiting list controls. Those randomised to the wait list control arm will be offered a place in the programme once the 6-month follow-up data have been collected.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Parental mental well-being will be measured using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) at baseline, end of programme and then 6 months

Secondary outcome measures

To be collected at baseline, end of programme and then 6 months
1. Child socio-emotional well-being will be measured by the Strengths and Difficulties Questionnaire (SDQ) – parent report.
2. Parenting practices: measured via a) Parenting Scale – a parent report of dysfunctional parenting practices; b) Parental Sense of Competence Scale – measuring parenting competencies, efficacy and satisfaction in parenting.
3. Child-parent relationship and parental stress - measured by Child-Parent Relationship Scale (short version)
4. Family relationships and conflict – measured using the Quality of Marriage Index
5. Social support – measured by selected items used in the Millennium Cohort Study and the Avon Longitudinal Study of Parents and Children.
6. Parental quality of life: – measured by the EQ-5D-5L.
7. Community engagement and use of local services – measured by items from the Citizenship Survey and Buckner Social Cohesion Scale.
8. Use of NHS, social care, criminal justice system and mainstream/special education services measured using retrospective questionnaires, adapted from previous measures on the Database of Instruments for Resource Use Measurement (http://www.dirum.org/).

Overall trial start date

01/03/2019

Overall trial end date

28/02/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parents attending the SFSC parenting programme in the participating areas
2. Parents of children aged 3-18 years

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

676 participants in main trial

Participant exclusion criteria

1. Unable or unwilling to provide written informed consent to participate
2. Already participating in another research study

Recruitment start date

01/07/2019

Recruitment end date

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL
Department of Epidemiology and Public Health UCL 1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

UCL

Sponsor details

62-72 Gower Street
London
WC1E 6BT
United Kingdom
020 3108 7907
n.mcnally@ucl.ac.uk

Sponsor type

University/education

Website

https://www.ucl.ac.uk/jro/contact-us

Funders

Funder type

Government

Funder name

National Institute for Health Research

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

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

28/02/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/03/2019: Ethics approval granted 27/02/2019 26/02/2019: Trial’s existence confirmed by funder