Condition category
Not Applicable
Date applied
03/12/2018
Date assigned
23/01/2019
Last edited
23/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Families Connect is a parental engagement programme for families with children aged 4–6, delivered in schools across the UK. The programme involves parents and children, and uses play to encourage learning. It focuses on three key areas: social and emotional development, literacy and language development; and numeracy and mathematics. It aims to provide parents with confidence and skills to support their child’s learning, build relationships between parents and schools, and make a difference to children’s communication, literacy, numeracy and social and emotional outcomes.
This study aims to investigate how well Families Connect works in improving children's vocabulary, numeracy and social and emotional development, and parents' engagement in their children's learning. The study will also investigate children’s, parents’, teachers’ and school leaders’ views on the programme.

Who can participate?
Families with a child or children in Reception or Year 1 in England and Wales, Y1/Y2 in Northern Ireland, and P1/P2 in Scotland, in the current school year (2018/19) can take part. Families must not have taken part in Families Connect before.

What does the study involve?
Families will be randomly allocated to one of two groups. One group will take part in Families Connect in the spring term 2019, and the other group will take part in Families Connect in the autumn term 2019.
Families Connect involves a set of 2-hour sessions in school over 8 weeks. There are eight sessions in total. The timings of the sessions are flexible to suit the families involved (for example, during school, after school or straddling the end of the school day). One hour of each session is for parents only; the other hour is for parents and children together. A snack and crèche facilities are usually provided.
Usually, two members of staff from the school will deliver the sessions. They will have been trained by Save the Children UK (SCUK) to do this. Staff from Save the Children UK (SCUK) will also visit the school to support some of the sessions.
Parents will complete a short questionnaire when they sign up to the trial, and again at the end of the term when they have participated in Families Connect. Each pupil will complete a short vocabulary assessment at the start of the trial – a test administrator will visit your child’s school to do this. Each pupil will then complete a short vocabulary assessment and a numeracy assessment at 8 weeks after the end of Families Connect, and again at 6 months after the end of the Families Connect programme– with a test administrator who will visit your child’s school to do this. Teachers will also complete a Strengths and Difficulties questionnaire for each pupil at the start, middle and end of the trial. This questionnaire collects special personal data, and will
only be used by researchers using IDs (no names will be attached to the file that researchers use). An attendance register will be completed for the 8-week programme. Parents and children may also be invited to take part in interviews about their experiences and views of the Families Connect programme. This will be with researchers from NFER or Queen’s University Belfast (QUB).

What are the possible benefits and risks of participating?
Families allocated to both groups will take part in Families Connect – just in different terms, so no one misses out. By taking part in the evaluation participants will be helping to find out if and how Families Connect helps children and parents, and how to develop the programme further for
other families in future. As a thank you for contributing to the study, families will receive from SCUK £20 for participating in the project (this is for families in both groups, and will be given out after the follow-up parent questionnaire at the end of the spring term 2019) and a book for each family.

Where is the study run from?
The National Foundation for Educational Research (NFER) (UK)

When is the study starting and how long is it expected to run for?
July 2018 to February 2020.

Who is funding the study?
The Nuffield Foundation (UK)

Who is the main contact?
Michael Neaves, NFER Researcher
FCTrial@nfer.ac.uk

Trial website

https://www.nfer.ac.uk/key-topics-expertise/nfer-education-trials-unit/current-projects/rct-evaluation-of-families-connect/

Contact information

Type

Public

Primary contact

Ms Pippa Lord

ORCID ID

Contact details

National Foundation for Educational Research
Unit G3
IT Centre
York Science Park
Heslington
York
YO10 5NP
United Kingdom
+44 (0)1904 567633
p.lord@nfer.ac.uk

Type

Public

Additional contact

Dr Christine Bradley

ORCID ID

Contact details

Save the Children
1 St. John's Lane
London
EC1M 4AR
United Kingdom
+44 (0)20 7012 6400
C.Bradley@savethechildren.org.uk

Type

Public

Additional contact

Dr Aideen Gildea

ORCID ID

http://orcid.org/0000-0002-0685-0132

Contact details

School of Social Sciences
Education and Social Work
Queen’s University Belfast
Room 69.01.007
69/71 University Street
Belfast BT7 1HL
Belfast
BT7 1HL
United Kingdom
+44 (0) 28 9097 5193
a.gildea@qub.ac.uk

Type

Scientific

Additional contact

Dr Ben Styles

ORCID ID

Contact details

National Foundation for Educational Research
The Mere
Upton Park
Slough
SL1 2DQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A within-school family-randomised controlled trial to evaluate the impact of the "Families Connect" (FC) programme.

Acronym

FCON

Study hypothesis

Implementing and taking part in Families Connect will positively influence children's receptive vocabulary, numeracy and social and emotional development. It will also positively influence parents' perceptions of their own parental self-efficacy, parental role construction and the home learning environment.

Ethics approval

NFER's Code of Practice Group, Jan - June 2018, and Save the Children UK's (SCUK) Ethics Committee clearance (January to June 2018), 04/07/2018, ref: FCON 04/07/2018.

Study design

Within-school randomised effectiveness trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

PIS for schools: https://www.nfer.ac.uk/for-schools/participate-in-research/randomised-controlled-trial-of-families-connect/ . PIS for parents: https://www.nfer.ac.uk/media/3114/fcon_information_sheet.pdf

Condition

This study is exploring the learning and social and emotional benefits of Families Connect on school children aged 4 to 6 years, and the capacity of parents' to engage with and support their child's learning.

Intervention

Two practitioners from each school are trained by SCUK in how to deliver the programme. The programme then involves eight 2-hour sessions (one session a week for 8 weeks), usually held towards the end of the school day, straddling the end of the school day or after school. The eight sessions cover: social and emotional development (Weeks 1 - 3), literacy, language and vocabulary (Weeks 4 and 5), numeracy (Weeks 6 and 7) and celebration and review (Week 8). The first half of each session is for parents only, where they learn about the theory behind the approach, watch the activity being modelled by the trained practitioner, and then practise the approach. The second half of each session is for parents and children, to try the activities together. Families are encouraged to use the activities at home each week with their child(ren).
1. The intervention group will take part in Families Connect in the Spring term 2019.
2. The control group will wait until after all the trial data collection is complete, and take part in Families Connect as a waitlist control in the Autumn 2019.
There will also be an implementation and process evaluation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Children's receptive vocabulary as measured by the British Pictorial Vocabulary Scale Version 3 (BPVS3; Dunn et al., 2009) at baseline (early January 2019), first follow-up (end April – early May 2019), and second follow-up (the primary outcome timepoint, mid-September to early October 2019), i.e. at baseline, immediately after the 8-week programme, and 6 months after the 8-week programme.

Secondary outcome measures

1. Children's numeracy development as measured by Hodder's Progress in Understanding Maths Assessment (PUMA; Colin and Cooke, 2015) at first follow-up (end April – early May 2019) and second follow-up (mid-September to early October 2019), i.e. immediately after the 8-week programme and 6 months after the 8 week programme. There is no baseline measurement, as there is no suitable age-appropriate numeracy test.
2. Children's social and emotional outcomes as measured by the teacher-completed Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) and the teacher-completed child soft skills questionnaire (CSS; SCUK) at baseline (early January 2019), first follow-up (end April – early May 2019), and second follow-up (the primary outcome timepoint, mid-September to early October 2019), i.e. at baseline, immediately after the 8-week programme, and 6 months after the 8-week programme.
3. Parental engagement assessed using a questionnaire combining the Parents' Perceptions of Parental Efficacy Scale (PES; Hoover-Dempsey and Sandler, 2005), the Parental Role Construction Scale (PRC; Sylva et al., 2008) and the KS1 Home Learning Environment Scale (HLE; Melhuish et al., 2001) at recruitment/baseline (Nov/Dec 2018) and first follow up (early April 2018), i.e. baseline and at Week 8 of the programme.

Overall trial start date

01/07/2018

Overall trial end date

28/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Schools:
1. School type: primary schools in the state maintained sector
2. School year groups: Reception and Year 1 in England and Wales, Y1 and Y2 in Northern Ireland, P1 and P2 in Scotland
3. Disadvantage: school-level Free School Meal (FSM) eligibility of greater than 20% in England, greater than 25% in Wales, greater than 40% in NI, and in areas of disadvantage in Scotland based on Pupil Equity Funding
4. Geography: North of England, South of England, Wales, Northern Ireland (NI) and Scotland
5. School size: medium to large schools (more than one form entry) where possible
6. School first language: English speaking
7. Previous experience of Families Connect: schools must be new to Families Connect or have only run it once before in their school.

Practitioners:
8. These staff must be teachers, teaching assistants or family support workers from within each school
9. They must not currently teach Reception or Year 1 (in England and Wales), Y1/Y2 (in NI), P1/P2 (in Scotland)

Family:
10. Age group: families with child(ren) aged 4 to 6 years (in Reception or Year 1 in England and Wales, in Y1/Y2 in NI, in P1/P2 in Scotland)
11. Disadvantage: Families Connect is a universal programme, however it aims to work in each cycle with at least 20% of families from disadvantaged backgrounds
12. More than one child: where a family has more than one child in this age range, all eligible children can attend (especially where an additional parent/guardian can attend). Where only one child attends, this will be the eldest.
13. SEN: Children with special educational needs (SEN) are eligible
14. EAL: families and children with English as an Additional Language (EAL) are eligible. Local knowledge will be needed as to the provision of translation/interpretation services.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

440 families in total. Made up of 25-30 schools, each with 16-20 families. Within each school families will be randomly split into intervention and control group. There will be 220 intervention families in total, and 220 control families.

Participant exclusion criteria

Families who have previously taken part in Families Connect with another child.

Recruitment start date

15/09/2018

Recruitment end date

10/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Foundation for Educational Research (NFER)
National Foundation for Educational Research The Mere, Upton Park Slough SL1 2DQ
Slough
SL1 2DQ
United Kingdom

Trial participating centre

Save the Children UK (SCUK)
1 St. John's Lane
London
EC1M 4AR
United Kingdom

Trial participating centre

Queen's University Belfast (QUB)
Queen’s University Belfast University Street Belfast BT7 1HL
Belfast
BT7 1HL
United Kingdom

Sponsor information

Organisation

Nuffield Foundation

Sponsor details

Nuffield Foundation
28 Bedford Square
London
WC1B 3JS
London
WC1B 3JS
United Kingdom
+44 (0)20 7631 0566
info@nuffieldfoundation.org

Sponsor type

Charity

Website

http://www.nuffieldfoundation.org/

Funders

Funder type

Charity

Funder name

Nuffield Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A full report from the study will be drafted in December 2019 with plans to publish it on NFER, SCUK and QUB websites in February 2020. Other academic papers and presentations will be made after February 2020.

IPD sharing statement
De-identified (i.e. no names or dates of birth) datasets generated during the study will the stored in the UK Data Archive (which can be accessed by approved/accredited researchers/research organisations) indefinitely; and in the Save the Children UK Programme Archive for up to 7 years (as part of its programmatic requirements). The datasets will also be stored securely at NFER for up to 1 year after publication of the research report. This data will include the primary and secondary outcomes data for each individual in the trial (de-identified, and using an ID number that is different to the ID number used in the trial). It will also include the fidelity/compliance data (e.g. number of sessions attended). It may also include the randomisation syntax (this will be published in an appendix in the report).
The purpose for lodging the data with the UK Data Archive is in the interest of open science, such that researchers can replicate our analysis, and inform wider strategies around parental engagement in learning in the early years and KS1. The SCUK Programme Archive is overseen by the SCUK Evaluation and Learning Team, and is used to undertake further analysis of programme outcomes and effectiveness for continuous development and improvement of their programmes. Datasets stored at NFER will only be accessible by a small number of named researchers and will be deleted 1 year after publication of the research report.
Opt-in consent is being obtained from parents, on behalf of themselves and their child(ren), for their data to be collected and analysed, and stored in de-identified form (as outlined above). Personal data is being collected with legitimate interest as the legal basis. SDQ data is special category personal data under GDPR. Ethically and legally, we are using opt-in consent as our basis for obtaining, using, sharing and storing this data. A Parent Privacy Notice is available here: https://www.nfer.ac.uk/media/3107/fcon_parent_privacy_notice.pdf

Intention to publish date

28/02/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes