Evaluation of a language intervention in Nursery classrooms

ISRCTN	ISRCTN29838552
DOI	https://doi.org/10.1186/ISRCTN29838552
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	N/A
Sponsor	University of Oxford
Funder	Nuffield Foundation

Submission date: 25/03/2019
Registration date: 26/03/2019
Last edited: 24/01/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study will evaluate the efficacy of the Nuffield Early Language Intervention – Nursery (NELI-N) programme, which is a 20-week language enrichment programme for children in nursery in the year before they start formal education (aged 3 - 4 years). The programme revolves around shared, interactive storybook reading and guided play. It has a whole class component, designed to enrich the language of all children in nursery, while also providing additional support with small group and individual sessions to improve the spoken language of children in nursery with language weaknesses. It is delivered by trained Nursery teachers and assistants.
The current trial will seek evidence for the efficacy of the programme in improving language skills and remediating language weaknesses of children in Nursery classrooms.

Who can participate?
Children attending nursery in the autumn term of 2019 (aged 3 – 4) in 60 primary schools in the UK.

What does the study involve?
Before the language enrichment programme begins all children in all participating nursery classrooms undergo a short app-based language assessment of four core language skills: expressive vocabulary, receptive vocabulary, sentence repetition and listening comprehension. Behavioural adjustment to nursery and knowledge of a selection of the vocabulary that will be taught during the intervention programme is also assessed.
From the language assessment, the 6 children in each participating nursery with the poorest language scores are selected for detailed language assessment.
After pretesting is completed, schools are randomly allocated to one of two groups to either receive the Nuffield Early Language Intervention – Nursery (NELI-N) programme or not receive it. Intervention group schools then receive the programme for 20 weeks (January to June 2020). Once the programme has been completed, all children in every nursery are assessed twice again, using the same assessments at posttest (the end of the intervention in June / July 2020) and at delayed posttest (roughly 6 months after the Intervention is completed in January/February 2021). The language skills of children in intervention schools will be compared to those in control schools to see how much the children who took part have improved as a result of the NELI-N programme.

What are the possible benefits and risks of participating?
Children in the intervention schools will benefit from additional teaching designed to improve their oral language skills. Schools in the control group are offered the Nuffield Early Language Intervention – Nursery (NELI-N) programme once the study is completed. There are no anticipated risks of participation.

Where is the study run from?
The University of Oxford (United Kingdom)

Who is funding the study?
The Nuffield Foundation

Who is the main contact?
Dr Gillian West
gillian.west@education.ox.ac.uk

Contact information

Dr Gillian West
Scientific

The Department of Education
15 Norham Gardens
Oxford
OX2 6PY
United Kingdom

ORCID ID	0000-0002-4413-3601
Phone	01865 274021
Email	gillian.west@education.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	The efficacy of an intensive 20-week language enrichment intervention in nursery classrooms: a cluster-randomised controlled trial
Study acronym	NELI-N
Study objectives	The current trial will seek evidence for the efficacy of The Nuffield Early Language Intervention programme in improving language skills and remediating language weaknesses in this age group. Receptive and expressive vocabulary, grammar and narrative skills will be assessed.
Ethics approval(s)	Approved 14/03/2019, Departmental Research Ethics Committee (DREC) in the Department of Education, The University of Oxford (15 Norham Gardens, Oxford, OX2 6PY; research.office@education.ox.ac.uk), ref: ED-CIA-19-145
Health condition(s) or problem(s) studied	Language learning difficulties
Intervention	Phase 1 – Screening. Every child in participating nursery classrooms will be assessed using the Automated Test of Language Abilities (ATLAS). This test assesses four core language skills: expressive vocabulary, receptive vocabulary, sentence repetition and listening comprehension. This testing will be conducted by nursery staff. Scoring of responses is done online using the app. These 4 subtests define a single language factor well and the scores for all 4 tests combined have excellent reliability (alpha = .93). Children’s behavioural adjustment will also be assessed, using the behavioural adjustment subscale of The Brief Early Skills and Support Index (BESSI: Hughes, Daly, Foley, White, & Devine, 2015), a teacher rating scale of children’s behaviour. Children will also be tested on their knowledge of a selection of the vocabulary that will be taught during the intervention programme, using tests of expressive picture naming and receptive picture selection. Phase 2 – In-depth testing. The 6 children in each participating nursery classroom with the poorest language scores (based on a composite z-score from the 4 ATLAS subtests) will be selected for further testing in Phase 2 as follows: CELF recalling sentences subtest, CELF expressive vocabulary subtest, Renfrew Action Picture test (information and grammar). An additional 4 children (without language difficulties) will be selected randomly from each classroom to receive these additional language tests. After screening is completed, schools will be randomised within each geographical area to one of two arms: intervention vs control. Randomisation will be conducted by an independent body. Intervention schools will receive the NELI-N programme and training in its use by the research team. The control schools will continue with normal teaching practices and will not administer the programme. Control schools will be offered the NELI-N programme the following year. ATLAS testing and behavioural assessment at posttest will be conducted by school staff and individually administered language assessments will be given by external testers trained to administer the tests by the research team. Schools will be randomised (within each geographical area) by an independent body, such as the University of Oxford Clinical Trials Unit, into one of two arms: intervention vs control.
Intervention type	Behavioural
Primary outcome measure(s)	The primary outcome will be a language latent variable defined by loadings from 4 ATLAS subtests (expressive vocabulary, receptive vocabulary, sentence repetition, and listening comprehension) plus the individually administered language tests (CELF recalling sentences subtest, CELF expressive vocabulary subtest, Renfrew Action Picture test (information and grammar). This language latent variable will be created for baseline, posttest (20 weeks) and delayed posttest (circa 40 weeks). Analyses will be based on latent variable ANCOVA models implemented in an SEM framework. The pretest latent language variable will be the covariate, and the posttest or delayed posttest latent variables will be the outcome measures. Errors for the language latent variable indicators may be correlated to provide an adequate model fit. The effects of the intervention will be measured by the y-standardized regression coefficient for a group dummy variable. The effects of clustering within schools will be accounted for by using robust (Huber-White) cluster standard errors (60 Schools). Separate ANCOVA models will be conducted to assess the effects of the language intervention programme on 1. Typically developing children (those not identified as having poor language skills); and 2. Children identified as having language difficulties (the 6 children in each class with the lowest language composite score who will get extra small group and individual language teaching).
Key secondary outcome measure(s)	The secondary outcome measures taken at baseline, posttest and delayed posttest will be: 1. Teachers’ ratings of children’s behaviour at school, using the behavioural adjustment subscale of The Brief Early Skills and Support Index (BESSI) 2. Knowledge of taught vocabulary assessed using expressive picture naming and receptive picture selection tests. These secondary analyses will use hierarchical linear models with random intercepts for schools. 3. Children’s letter sound knowledge and early word reading skill, assessed with subtests from the York Assessment of Reading for Comprehension (YARC) at delayed posttest only (circa 40 weeks after baseline). We will assess the extent to which children in the intervention groups (separately for typically developing children and children with language difficulties) show improvements, using latent variable ANCOVA models with the language pretest latent variable as the pretest and a latent variable for letter-sound knowledge or Early Word Reading as the outcome latent variables (Latent variables for these two outcome measures will be constructed by using item parcelling)
Completion date	30/12/2020

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	3 Years
Upper age limit	4 Years
Sex	All
Target sample size at registration	360
Total final enrolment	438
Key inclusion criteria	1. Attending nursery within a state primary school during the autumn school term in 2019. 2. Aged 3 to 4 years at pretest 3. Children receiving in-depth language assessments and additional targeted intervention support will be selected for having language weaknesses in comparison to their peers at pretest.
Key exclusion criteria	1. Start nursery for the first time after 1st December 2019 2. Significant visual impairment 3. Significant auditory impairment 4. Significant behavioural difficulties, such that they would not be able to take part in whole class or small group activities.
Date of first enrolment	01/04/2019
Date of final enrolment	30/07/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The University of Oxford

The Department of Education
15 Norham Gardens
Oxford
OX2 6PY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	The dataset used for analysis during the current study will be stored in a non-publically available repository (https://reshare.ukdataservice.ac.uk) after completion of the trial. The dataset will contain only anonymised data and will include scores for the assessments taken at pretest, posttest and delayed posttest.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		23/01/2024	24/01/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/01/2024: Publication reference and total final enrolment added.
29/03/2019: Internal review.
26/03/2019: Trial’s existence confirmed by IRB