Condition category
Not Applicable
Date applied
27/02/2018
Date assigned
07/10/2019
Last edited
07/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to explore the Home Learning Environment (HLE) in disadvantaged homes and the extent to which it can be subject to change, using an early years parent and child engagement programme (Early Words Together) as a catalyst for change. Early Words Together (EWT) consists of six one-hour one-to-one or small group (e.g. 2-3 parents) sessions with parents and their children to increase children’s communication, language and literacy skills by improving family engagement and facilitating change in the HLE. The programme has previously been shown to impact on children’s language and literacy skills but has not been subject of a randomised controlled trial (RCT). This pilot RCT is the next step in building the programme’s evidence base in accordance with the Early Intervention Foundation’s levels of evidence.

Who can participate?
Twelve settings will be recruited across three geographical locations. Settings will be eligible to participate if they have not previously delivered EWT and:
1. Are located in one of the 25% most deprived Local Authorities in England (using Indices of Multiple Deprivation, 2015)
2. Have more than 40% of children registered as eligible for Pupil Premium
3. Respond to an invitation from the research team and are willing to take part
4. Can demonstrate good levels of parental engagement to ensure viable numbers for recruitment and retention to the study, and, if randomised to the intervention group, programme delivery (e.g. through attendance at parent meetings and events etc)
5. Are willing to support the intervention.
Study participants will be recruited from parents of children aged 3-4 in Foundation 1 classes in recruited pre-school settings.

What does the study involve?
Settings will be randomly allocated to one of two groups: either the intervention group or the control group. Settings in the intervention group will receive training in the programme. Parents in the intervention group will receive the EWT programme over a six-week period through their pre-school setting. Parents in the control group will continue with practice as usual, but will receive £5 of high street vouchers for participating in each round of data collection. All parents will complete a demographic questionnaire at point of recruitment. Intervention parents will complete the Home Environment Questionnaire (HEQ) and Ages and Stages Questionnaire (ASQ) two weeks before programme delivery and again six months after the initial administration. At this stage they will also be asked to complete a questionnaire regarding the programme. The intervention children will be administered the British Picture Vocabulary Scale (BPVS) at the same time points. Alongside this, a subsection of these parents and their children who have consented will undertake a home observation at two weeks before programme delivery and six months later. Parents in the control group will complete the questionnaires (HEQ & ASQ) and (where applicable) the home observation and their children will be administered the BPVS at timepoints to match those of the intervention group.

What are the possible benefits and risks of participating?
The researchers anticipate the main benefits to be an enhanced HLE, resulting in a significant improvement in child language outcomes for those in the intervention group. There are no anticipated risks associated with participation in the programme given positive outcomes in previous studies.

Where is the study run from?
The study will be in selected settings in Doncaster, Rotherham and Bradford.

When is study starting and how long is it expected to run for?
September 2017 to July 2020

Who is funding the study?
The Nuffield Foundation

Who is the main contact?
Dr Louise Tracey
louise.tracey@york.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Louise Tracey

ORCID ID

http://orcid.org/0000-0002-8304-613X

Contact details

Department of Education
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 328160
louise.tracey@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Assessing changes in preschoolers’ home learning environment following the Early Words Together programme

Acronym

Study hypothesis

The aim of this study is to explore the Home Learning Environment in disadvantaged homes and the extent to which it can be enhanced, using an early years parent and child engagement programme (Early Words Together) as a catalyst for change

Ethics approval

Approved 21/09/2017, Education Ethics Committee University of York (Department of Education
D/P/202B, Derwent College, University of York, York, YO10 5DD, UK; +44 (0)1904 324476; education-research-administrator@york.ac.uk) ref: 17/23

Study design

Two-arm between setting pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Home Learning Environment, children's language acquisition

Intervention

Settings (pre-schools) are randomly allocated to intervention or control conditions. Randomization will be at the setting-level to reduce the possibilities of diffusion which could occur with an in-school design. Schools were stratified by region (Doncaster, Rotherham, Bradford) and then randomised using minimisation on a 1:1 allocation within region. Randomisation was conducted and recorded using MinimPy software (Saghaei & Saghaei, 2011).
1. Teachers in Foundation 1 receive 1 day of CPD and co-ordinate the delivery of the six-week Early Words Together programme to participating parents and their 3-4-year-old children by volunteers. Programme to be delivered in successive waves to different cohorts of participants over 4 academic terms (Summer 2018-Summer 2019).
2. Teachers in the control condition continue with usual practice.

Parents complete a bespoke demographic questionnaire on recruitment.
The intervention children will be administered the BPVS-III approximately two weeks prior to programme delivery and again, six months after the initial administration. Intervention parents will complete the HEQ and ASQ at the same time points. Alongside this a subsection of these parents and their children who have consented to a substudy will undertake a home observation.
A similar proportion of control children and their parents will be randomly selected at each wave of delivery to be assessed at the same time points (two weeks prior to intervention programme delivery and six months later).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Child primary outcome measure:
Receptive vocabulary measured using the British Picture Vocabulary Scale (BPVS-III; Dunn, Dunn and NfER, 2009)

Parent primary outcome measure:
Home Learning Environment measured using the Home Environment Questionnaire (HEQ; Miser and Hupp, 2012). It includes items which relate to resources available in the home, home academic activities, and outside the home activities.

Each of these measures is administered prior to programme delivery (or equivalent time period for control families) and six months after the pre-test. The programme was designed to be delivered each half term during the period of the study. So, for example, for intervention participants receiving programme delivery in the second half term of the Summer Term 2018 the pre-test occurred in May 2018 and the post-test in November 2018. Control families were randomly selected to act as though receiving the programme during that time period and pre- and post-tested at the same timepoints.

Secondary outcome measures

1. Child’s communication, gross motor skills, fine motor skills, problem solving, and personal-social skills, measured using the Ages & Stages Questionnaire®, Third edition (ASQ®-3) (Squires and Brickers, 2009)
2. Quality of parent-child social interactions with a focus on verbal behaviours, measured using the home observation measure, administered to a sub-sample of participants, adapted from the Play and Reading Observation Tool (PAROT; Pye, 2015) and the Dyadic Parent-Child Interaction Coding Scheme (DPICS; Robinson and Eyberg, 1981)

Each of these measures is administered prior to programme delivery (or equivalent time period for control families) and six months after the pre-test. The programme was designed to be delivery each half term during the period of the study. So, for example, for intervention participants receiving programme delivery in the second half term of the Summer Term 2018 the pre-test occurred in May 2018 and the post-test in November 2018. Control families were randomly selected to act as though receiving the programme during that time period and pre- and post-tested at the same time points.

Overall trial start date

01/09/2017

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The settings selected will not have previously delivered the Early Words Together programme. The target sample will be drawn from a population of parents with children aged 3 to 4 years old who attend one of the 12 settings recruited to the study (6 settings per area). Settings will be included if they:

1. Are located in one of the 25% most deprived Local Authorities in England (using Indices of Multiple Deprivation, 2015)
2. Have more than 40% of children registered as eligible for Pupil Premium
3. Respond to an invitation from the research team and are willing to take part
4. Can demonstrate good levels of parental engagement to ensure viable numbers for recruitment and retention to the study, and, if randomised to the intervention group, programme delivery (e.g. through attendance at parent meetings and events etc.)
5. Are willing to support the intervention

All parents (primary caregivers) who have the main responsibility of a child aged 3 to 4 years who is attending one of the settings recruited to take part in this study will be eligible for the study, alongside their child.

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

12 settings, across 3 clusters (6; 4; 2). 360 parent-child dyads.

Participant exclusion criteria

1. Settings who have implemented the programme previously
2. Parents who are unable to commit to the six-week programmne

Recruitment start date

25/09/2017

Recruitment end date

31/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
Berrick Saul Building
York
YO31 7TU
United Kingdom

Trial participating centre

National Literacy Trust
68 South Lambeth Road
London
SW8 1RL
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

-
York
YO10 5DD
United Kingdom
+44 (0)1904 320000
education-research-administrator@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

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

Final Report to Funders (Nuffield Foundation) due May 2020.
A report will be published on the National Literacy Trust website and be visible on the University of York PURE system.
There are also plans for conference presentations and to publish in national and internationally recognised academic journals.
Additional documents will not be made available.

IPD sharing statement:
It has been planned that anonymised data will be deposited in the UK Data Archive (https://www.data-archive.ac.uk/). It is planned to be available from 2021. Informed consent was obtained from participants at recruitment to the evaluation and approved by Education Ethics Committee, University of York.

Intention to publish date

31/05/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/10/2019: Trial’s existence confirmed by Department of Education Ethics Committee University of York