Condition category
Not Applicable
Date applied
07/10/2019
Date assigned
14/11/2019
Last edited
15/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The study evaluates the effectiveness of the Raising Early Achievement in Literacy (REAL) programme. It is an intervention that seeks to support children’s early literacy and language by working with parents and practitioners to improve children’s home learning environment. REAL is a programme originally developed and delivered by the University of Sheffield. The programme trains practitioners (such as nursery staff) to support children and families, conduct home visits and provide events to improve children’s home learning environment and literacy

What does the study involve?
Children will be randomly allocated to one of two groups. In the intervention group, families will receive visits of Early Year practitioners who will advise them on developing a home learning environment. Children in the control group, will continue using current best practice.

All children will take a literacy test at the start and end of the school year. We will compare levels of literacy attainment for the treatment and control group

What are the possible benefits and risks of participating?
REAL is designed to improve literacy attainment for early years children. There are no potential risks

Where is the study run from?
National Centre for Social Research (NatCen) (UK)

When is the study starting and how long is it expected to run for?
The study started in March 2019 and will finish in October 2021

Who is funding the study?
The Education Endowment Foundation (EEF) (UK)

Who is the main contact?
Anysia Nguyen
Anysia.Nguyen@natcen.ac.uk

More information can be found at:
http://www.natcen.ac.uk/RealProgramme

Trial website

http://www.natcen.ac.uk/RealProgramme

Contact information

Type

Scientific

Primary contact

Miss Anysia Nguyen

ORCID ID

http://orcid.org/0000-0001-8837-7424

Contact details

35 Northampton Square
London
EC1V 0AX
United Kingdom
+44 (0)207 2501866
Anysia.Nguyen@natcen.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

P13582

Study information

Scientific title

Home learning environment support to improve early literacy skills of 3- to 5-year-old children: A randomised controlled efficacy trial of the REAL programme

Acronym

REAL

Study hypothesis

1. The REAL programme would improve children's home learning environment
2. The REAL programme would raise children's early literacy skills
3. The REAL programme would improve children's emergent writing skills

Ethics approval

Approval pending, NatCen Ethics Review Committee (35 Northampton Square, London EC1V 0AX; +44 (0)207 250 1866; info@natcen.ac.uk), ref: n/a

Study design

Two-arm multi-site child-level randomised controlled efficacy trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

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

Condition

Early-years education

Intervention

This is a two-arm multi-site child-level randomised controlled efficacy trial of REAL on the early literacy development of children aged 3 to 5 years old. Nurseries agreeing to participate in the trial will identify 8 to 16 children eligible to receive the intervention. Within each participating nursery, families of eligible children that agree to participate in the trial will be allocated to one of the two groups using blocked randomisation by nursery. The allocation ratio between treatment and control within each nursery will be a 1:1 ratio. Analysts will be blinded to the identity of nurseries and families at the time of randomisation. Early Years assessors will be blinded to treatment allocation when administering the assessment.

The intervention is the Raising Early Achievement in Literacy (REAL) programme, which has been designed by the National Children's Bureau (NCB). The programme aims to help practitioners (usually nursery teacher or reception teachers) to build parents' knowledge and confidence in creating a home learning environment that supports and encourages their children's early literacy and development.

At each nursery setting, practitioners will identify 8-16 children who they think will benefit from the intervention. Of these, around eight children and their parents/carers at each setting will be selected at random to receive the intervention. The families of children in the control group will receive a business as usual approach to teaching literacy. The intervention group will receive at least eight home visits from a trained practitioners. Practitioners have the option to conduct an additional two visits up to a maximum of 10 home visits. Each visit lasts up to one hour.

The REAL Programme will be delivered over four school terms, starting when the children are in the Spring term of the nursery year and concluding when they are in the Spring term of Reception year at primary school. The practitioner will continue to conduct home visits with families during the Reception year as part of the intervention, unless the child moves to another school outside of the local area.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Early literacy development as measured by the Preschool Early Literacy Indicators (PELI) assessment. To be collected at baseline (Sept-Oct 2019) and endline (Feb-March 2021)

Secondary outcome measures

1. Emergent writing skills measured by the Sheffield Early Literacy Development Profile (SELDP)
2. Children's home learning environment measured by a 12-item instrument proposed by Niklas et al (2014)
Both to be collected at baseline (Sept-Oct 2019), and endline (Feb-March 2021)

Overall trial start date

01/01/2019

Overall trial end date

30/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The following eligibility criteria apply to nurseries:
1. Type of nursery: Only school-based nurseries will be eligible to take part.
2. Prior REAL involvement: nurseries and practitioners should not have any prior exposure to The REAL programme.
3. Availability: the school’s Early Years coordinator, in conjunction with the school headteacher, will identify one practitioner to undertake training and be able to commit a half day per week to focus on programme delivery (should the nursery be assigned to receive the intervention). All nurseries also need to have identified a key point of contact to support evaluation activities.

The following eligibility criteria apply to children:
1. Aged 3-4 in August 2019.
2. Children needing additional support in early literacy based on practitioners' prior knowledge of the child and of the child’s parent(s)/carers.

Practitioners will be asked to keep a record of the criteria they use to identify eligible children. After this information is collected, nurseries’ response patterns will be analysed.

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

The proposed target recruitment sample is 62 nurseries with 16 children per nursery. A maximum of 992 children will engage in the trial across all nurseries

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2019

Recruitment end date

31/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NatCen Social Research
35 Northampton Square
London
EC1V 0AX
United Kingdom

Sponsor information

Organisation

Education Endowment Foundation

Sponsor details

5th Floor
Millbank Tower
21-24 Millbank
London
SW1P 4QP
United Kingdom
02078021676
info@eefoundation.org.uk

Sponsor type

Charity

Website

https://educationendowmentfoundation.org.uk/

Funders

Funder type

Charity

Funder name

Education Endowment Foundation

Alternative name(s)

EEF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A protocol will be published on the Education Endowment Foundation website in Autumn 2019 (https://educationendowmentfoundation.org.uk/projects-and-evaluation/projects/the-real-programme/). A Statistical Analysis Plan will be published on the same website in Spring 2020. A final report will be published in Autumn 2021.

IPD sharing statement:
The datasets analysed in this study will be stored in a non-publicly available repository; the Fischer Family Trust (FFT) archive (https://fft.org.uk/). The dataset will be at individual level (i.e. one row per pupil), including information on the treatment they receive and the outcomes of testing (at baseline and follow-up). Data will be obtained and held under the legal basis of legitimate interests with individuals able to express objections to data processing until the data is archived. The data will be archived for an indefinite period for archiving, historical or scientific research purposes, with access criteria determined by the Fischer Family Trust and the Education Endowment Foundation (EEF). Data will be available in a pseudo-anonymised format so that future analysis incorporating data from the National Pupil Database (NPD) could be facilitated

Intention to publish date

30/11/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/11/2019: Internal review. 13/11/2019: Trial’s existence confirmed by NatCen