Enhancing pragmatic language skills for young children with social communication difficulties
| ISRCTN | ISRCTN17561417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17561417 |
| IRAS number | 315014 |
| Secondary identifying numbers | CPMS 52840, IRAS 315014 |
- Submission date
- 15/09/2022
- Registration date
- 19/12/2022
- Last edited
- 26/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 January 2025
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)
Contact information
Principal Investigator
University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom
 ORCID ID |
0000-0001-9246-7756 |
|---|---|
| Phone | +44 (0)1582 489056 |
| suzanne.murphy@beds.ac.uk |
Scientific
Assistant Professor, Health & Education Research
Department of Health Sciences
York Trials Unit, University of York
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321692 |
|---|---|
| Lyn.Robinson-Smith@york.ac.uk |
Study information
| Study design | Cluster-randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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 |
| 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 | 15/01/2025 |
Eligibility
| 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: 800; UK Sample Size: 800 |
| Total final enrolment | 821 |
| 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 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Harrow
HA1 1UJ
United Kingdom
Luton
LU3 1NS
United Kingdom
Luton
LU3 2UE
United Kingdom
Harrow
HA2 8LS
United Kingdom
Brent
London
NW10 9BX
United Kingdom
Brent
London
NW2 5PE
United Kingdom
Harrow Weald
HA3 6LE
United Kingdom
Kenton
Harrow
HA3 9JA
United Kingdom
Wembley
HA9 7NW
United Kingdom
St Albans
AL1 5PG
United Kingdom
Abbots Langley
WD5 0HW
United Kingdom
St Albans
AL3 6EL
United Kingdom
St. Albans
AL1 5QP
United Kingdom
Wigmore Primary School
Luton
LU2 9TB
United Kingdom
Hemel Hempstead
HP2 5TD
United Kingdom
Hertfordshire
WD25 9RH
United Kingdom
Caddington
LU1 4BB
United Kingdom
Hemel Hempstead
HP1 2QH
United Kingdom
St Albans
AL4 9RS
United Kingdom
Wembley
HA9 8NA
United Kingdom
London
NW10 0BG
United Kingdom
Sponsor information
University/education
Professor Gurch Randhawa (Sponsor Representative)
Putteridge Bury campus
Hitchin Road
Luton
LU2 8LE
England
United Kingdom
| Phone | +44 (0)1582 743797 |
|---|---|
| gurch.randhawa@beds.ac.uk | |
| Website | https://www.beds.ac.uk/ |
"ROR" |
https://ror.org/0400avk24 |
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository: the UK Data Service repository (https://ukdataservice.ac.uk/) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 21/11/2021 | 05/12/2022 | No | No |
| Protocol article | 13/05/2024 | 14/05/2024 | Yes | No | |
| Protocol file | version 1.1 | 19/06/2023 | 19/07/2024 | No | No |
Additional files
Editorial Notes
26/03/2025: The following changes were made to the study record:
1. The total final enrolment was changed from 814 to 821.
2. The overall study end date was changed from 30/11/2024 to 15/01/2025.
3. IPD sharing statement added.
19/07/2024: The following changes were made to the study record:
1. Protocol uploaded.
2. The target number of participants was changed from 1008 to 800.
3. Total final enrolment added.
14/05/2024: Publication reference added.
12/04/2024: The recruitment end date was changed from 29/02/2024 to 30/04/2024.
13/12/2023: The recruitment end date was changed from 31/12/2023 to 29/02/2024.
16/01/2023: Internal review.
16/09/2022: Trial's existence confirmed by the NIHR.
