Enhancing pragmatic language skills for young children with social communication difficulties

Plain English Summary

Background and study aims
Many children experience difficulties with social communication (also known as pragmatic language ability); that is, the use of language for social purposes. These children struggle with conversational tasks such as appropriate use of greetings, conversational turn-taking, understanding of non-literal language such as jokes, irony or sarcasm, social conventions such as politeness, taking the perspective of the other person and responding with relevant information. These difficulties have profound effects on children’s social development, mental health, and education and are strongly associated with bullying, isolation and school exclusion. There is a lack of evidence-based, cost-effective interventions for such children. We have developed a novel approach ‘Enhancing Pragmatic Language skills for Young children with Social communication disorder’ (E-PLAYS) using a fun computer game. E-PLAYS is for children 5-7 years old and is used by children in pairs. Games designers, teachers, speech and language therapists and children helped us to develop E-PLAYS, and young people with communication difficulties gave feedback.

We carried out two previous studies: a pilot trial and a feasibility study. These studies show that children receiving E-PLAYS scored better on language tests, used more appropriate verbal communication and showed more enjoyment of social interaction than a similar group of children who didn’t receive E-PLAYS. The studies also showed that enough children agreed to take part, that schools' teaching assistants could deliver E-PLAYS the programme faithfully to the manual and that teaching assistants and children rated the game as fun and enjoyable. A 4-minute video of two children playing E-PLAYS is available at: https://drive.google.com/open?id=1n3TFfJ57HOLMDK5IDd4eHLKcEL_f4ZR2. Our two previous studies were run with small numbers; we now want to run a large trial and follow up with children after 40 weeks to find out whether E-PLAYS could be delivered effectively by teaching assistants in many schools and whether it is cost-effective to do so. If it is, we will be able to distribute E-PLAYS potentially to all schools in the UK. If we show that E-PLAYS is effective for children with social communication difficulties, we would be able to make it available immediately, together with an online manual, free of charge to all schools in the UK. Against a backdrop in 2020 where children’s socialisation with peers, communication skills and peer relations have suffered and the most deprived individuals have been hit the hardest, E-PLAYS is aiming to develop children’s social and collaborative skills by making novel use of technology and is likely to be welcomed by schools, parents and children.

Who can participate?
Children aged 5-7 years old whose teachers consider them to have social communication difficulty in state primary schools or special schools

What does the study involve?
We will ask schools to take part in the study, we will measure children's pragmatic language skills before and after using E-PLAYS for 10 weeks with their teaching assistants and a partner child from their class. Their teachers will observe classroom behaviours to see if they notice any differences. We will observe and interview children to see whether they like using E-PLAYS and we will observe and interview teaching assistants and also ask them to complete a survey and take part in a focus group to see how they use E-PLAYS, if it fits well into their school day, if they feel confident with it and if they think the instructions are clear. We will ask the child’s parent/carer to complete surveys which will tell us about the child’s health.

What are the possible benefits and risks of participating?
E-PLAYS is a low-cost and effective tool targeting a specific group of children who are currently poorly supported by technology, and we expect the project to demonstrate significant benefits to their communication skills from using it. We do not anticipate any risks to children taking part.

Where is the study run from?
University of Bedfordshire (UK)

When is the study starting and how long is it expected to run for?
September 2021 to November 2024

Who is funding the study?
National Institute for Health Research (NIHR) Public Health Research (PHR) Programme (NIHR131745) (UK)

Who is the main contact?
Dr Suzanne Murphy, Suzanne.Murphy@beds.ac.uk (UK)

Study website

Type

Principal Investigator

Contact name

Dr Suzanne Murphy

ORCID ID

http://orcid.org/0000-0001-9246-7756

Contact details

University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom
+44 (0)1582 489056
suzanne.murphy@beds.ac.uk

Type

Scientific

Contact name

Dr Lyn Robinson-Smith

ORCID ID

Contact details

Assistant Professor
Health & Education Research
Department of Health Sciences
York Trials Unit
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 321692
Lyn.Robinson-Smith@york.ac.uk

EudraCT/CTIS number

Nil known

IRAS number

315014

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 52840, IRAS 315014

Scientific title

E-PLAYS-2 (Enhancing Pragmatic Language skills for Young children with Social communication impairment) trial; evaluation of a computerised intervention to promote communicative development and collaborative skills in children

Acronym

E-PLAYS-2

Study hypothesis

For young children with social communication difficulties, E-PLAYS is effective and cost-effective, by comparison with usual care, for improving pragmatic language skills at long-term (40 weeks) follow-up

Ethics approval(s)

Approved 23/02/2022, The Ethics Committee of the Institute for Health Research (University of Bedfordshire, Institute for Health Research, Putteridge Bury, Hitchin Road, Luton, Bedfordshire, LU2 8LE, UK; +44 (0)1234 400400; EthicsIHR@beds.ac.uk), ref: IHREC971

Study design

Cluster-randomized controlled study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Study setting(s)

Community

Study type

Treatment

Patient information sheet

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

Condition

Disorders of psychological development

Intervention

The E-PLAYS programme is built around a computer game for two players with 10 weekly sessions, 30 minutes each; teaching assistants supervise all sessions. Children play the game with a teaching assistant for 5 sessions and a classmate for 5 sessions. During their sessions teaching assistants play the game to guide the child through real-life conversational exchanges with a specific focus on (a) requesting optimally useful information (b) giving helpful directions and (c) asking for clarification. Sessions with the classmate give the child an opportunity to practice these newly-acquired skills and also to learn collaboration skills through joint problem-solving with a peer.

Intervention type

Behavioural

Primary outcome measure

Pragmatic language skills measured using the Test of Pragmatic Skills (TPS) at baseline and 35-40 weeks post-randomisation

Secondary outcome measures

1. Pragmatic language skills measured using the test of Pragmatic skills at baseline and follow-up at 15-20 weeks post-randomisation
2. Specific language skills measured using the Clinical Evaluations of Language Fundamentals-5 (CELF-5) subscales Recalling sentence and Following Directions at baseline, 15-20, weeks and 35-40 weeks post-randomisation
3. Specific language skills measured using the Expression, Reception and Recall of Narrative Instrument (ERNNI) at baseline, 15-20, weeks and 35-40 weeks post-randomisation
4. Perspective-taking skills measured using the Droodles Task at baseline, 15-20 weeks and 35-40 weeks post-randomisation
5. Perspective-taking skills measured using the Communication Test at baseline, 15-20 weeks and 35-40 weeks post-randomisation
6. Quality of life measured using the Child Health Utility (CHU-9D) at baseline, 15-20 weeks and 35-40 weeks post-randomisation
7. Health-related quality of life measured using the EQ-5D-Y at baseline, 15-20 weeks and 35-40 weeks post-randomisation
8. Resource use measured using a bespoke questionnaire at baseline, 15-20 weeks and 35-40 weeks post-randomisation
9. Communication impairments measured using the Children’s Communication Checklist-2 (CCC-2) at baseline 15-20, weeks and 35-40 weeks post-randomisation
10. Behavioural, emotional and peer problems measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline, 15-20 weeks and 35-40 weeks post-randomisation
11. Pragmatic language skills among partner children (those without a social communication difficulty) measured using the Test of Pragmatic Skills (TPS) at baseline, 15-20 weeks and 35-40 weeks post-randomisation

Overall study start date

01/09/2021

Overall study end date

30/11/2024

Reason abandoned (if study stopped)

Participant inclusion criteria

School inclusion criteria:
1. State-funded infant or primary school or special needs school with year groups 1-3
2. Schools that have computer facilities (two available laptops) for children to use
3. Agree to all requirements outlined in the E-PLAYS-2 Memorandum of Understanding and Data Sharing Agreement

Focal child inclusion criteria:
1. Children aged 5-7 years old
2. Children who meet the criteria for social communication difficulties as determined by the Social Communication Behaviour Checklist completed by the child's teacher
3. Children whose parent/carers provide consent for them to take part in the E-PLAYS-2 trial
4. Children who complete all the research assistant administrated baseline assessments
5. Child’s parent/carer willing to complete relevant questionnaires

Partner child inclusion criteria:
1. Children aged 5-7 years old
2. Children who do not meet the criteria for social communication difficulties as determined by the Social Communication Behaviour Checklist
3. Children whose parents/carers provide consent for them to take part in the E-PLAYS-2 trial

Participant type(s)

Healthy volunteer, Patient

Age group

Child

Lower age limit

5 Years

Upper age limit

7 Years

Sex

Both

Target number of participants

Planned Sample Size: 1008; UK Sample Size: 1008

Participant exclusion criteria

School exclusion criteria:
1. Independent, fee-paying schools
2. Schools that are taking part in other language and communication research/trials aimed at pupils in Year 1 and Year 2
3. Schools that have previously used E-PLAYS; Schools that took part in the E-PLAYS feasibility study

Recruitment start date

01/03/2022

Recruitment end date

30/04/2024

Countries of recruitment

England, United Kingdom

Study participating centre

Marlborough Primary School
Marlborough Hill
Harrow
HA1 1UJ
United Kingdom

Study participating centre

Denbigh Primary School
Denbigh Road
Luton
LU3 1NS
United Kingdom

Study participating centre

The Meads Primary School
Sawtry Close
Luton
LU3 2UE
United Kingdom

Study participating centre

The Welldon Park Academy
Wyvenhoe Road
Harrow
HA2 8LS
United Kingdom

Study participating centre

Mitchell Brook Primary School
Bridge Road
Brent
London
NW10 9BX
United Kingdom

Study participating centre

St Andrew and St Francis Cofe Primary School
Belton Road
Brent
London
NW2 5PE
United Kingdom

Study participating centre

St Teresa's Catholic Primary School
Long Elmes
Harrow Weald
HA3 6LE
United Kingdom

Study participating centre

Kenmore Park Infant and Nursery School
Moorhouse Road
Kenton
Harrow
HA3 9JA
United Kingdom

Study participating centre

Wembley Primary School
East Lane
Wembley
HA9 7NW
United Kingdom

Study participating centre

Camp Primary and Nursery School
Camp Road
St Albans
AL1 5PG
United Kingdom

Study participating centre

Divine Saviour Roman Catholic Primary School
Broomfield Rise
Abbots Langley
WD5 0HW
United Kingdom

Study participating centre

Margaret Wix Primary School
High Oaks
St Albans
AL3 6EL
United Kingdom

Study participating centre

Windermere Primary School
Windermere Avenue
St. Albans
AL1 5QP
United Kingdom

Study participating centre

Wigmore Primary
Twyford Drive
Wigmore Primary School
Luton
LU2 9TB
United Kingdom

Study participating centre

Hammond Academy
Cambrian Way
Hemel Hempstead
HP2 5TD
United Kingdom

Study participating centre

The Grove Academy
Fourth Avenue
Hertfordshire
WD25 9RH
United Kingdom

Study participating centre

St Mary's Catholic Primary School
Dunstable Road
Caddington
LU1 4BB
United Kingdom

Study participating centre

Micklem Primary School
Boxted Road
Hemel Hempstead
HP1 2QH
United Kingdom

Study participating centre

Skyswood Primary & Nursery School
Chandlers Road
St Albans
AL4 9RS
United Kingdom

Study participating centre

Preston Manor School
Carlton Avenue East
Wembley
HA9 8NA
United Kingdom

Study participating centre

St Margaret Clitherow Rc Primary School
Quainton Street
London
NW10 0BG
United Kingdom

Organisation

University of Bedfordshire

Sponsor details

Professor Gurch Randhawa (Sponsor Representative)
Putteridge Bury campus
Hitchin Road
Luton
LU2 8LE
England
United Kingdom
+44 (0)1582 743797
gurch.randhawa@beds.ac.uk

Sponsor type

University/education

Website

https://www.beds.ac.uk/

ROR

https://ror.org/0400avk24

Funder type

Government

Funder name

National Institute for Health and Care Research Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR131745

Alternative name(s)

National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal within one year of the trial end date. Participants will be provided with a report of the findings written in a style accessible for lay people, which will be accessible via schools. We will also provide ongoing reports through our website as the trial progresses. In order to disseminate E-PLAYS to professionals, the research team will offer workshops with the Royal College of Speech and Language Therapists and the children’s communication charity Speech and Language UK (formerly I CAN). We will also publicise through the National Association of Professionals concerned with Language Impaired Children (NAPLIC), Autistica, the National Autistic Society and the Communication Trust Consortium. We will also apply to have E-PLAYS registered on websites listing and reviewing evidence-based language interventions e.g., Education Endowment Foundation, and the Learning Foundation. Special Educational Needs and Disabilities (SEND) teams in local authorities and Clinical Commissioning Groups (CCGs) are likely to be responsive to efforts to distribute a cost-free product. Should E-PLAYS prove to be effective at the end of this trial, distribution and implementation could start at once as it is a web-based intervention.

Intention to publish date

31/12/2025

Individual participant data (IPD) sharing plan

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

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs

• 42384 Protocol 21Nov2021.pdf