Condition category
Mental and Behavioural Disorders
Date applied
08/04/2019
Date assigned
23/04/2019
Last edited
06/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 04/07/2020:
Background and study aims
Children with autistic spectrum disorder (ASD) have a higher prevalence of mental health problems than typically developing children, including anxiety and low mood, disruptive, and repetitive behaviours. Research shows that severe social difficulties represent a cost to the NHS and social care across childhood and adulthood (NICE, 2013; National Audit Office, 2009). Social Stories™ are purported to promote calmer classrooms with improved learning/better integration in special and mainstream education settings, and improved social behaviours. Using Social Stories™, children with ASD have shown improvements across a range of behaviours including social interaction, decision making, reduced disruptive behaviours, tantrums and frustration. The aim of this study is to find out whether Social Stories™ can improve social responsiveness in children with ASD in primary schools.

Who can participate?
Children aged 4-11 who attend a school in Yorkshire and Humber and who have a diagnosis of ASD and daily challenging behaviour

What does the study involve?
Parents and teachers complete questionnaires at three times: at the beginning of the study (baseline), six weeks into the study and six months into the study. These questionnaires collect information about demographics, the social responsiveness of the child, quality of life and health resource use. After the baseline questionnaires have been completed for all participants at the school, the school is randomly assigned to either the Social Stories™ intervention or to the control arm (which is care as usual (CAU) by the school). Assignment is decided at random by a computer and children receive all other treatment or support as usual regardless of allocation. If the school gets allocated to the intervention, a teacher is trained to write and read a Social Story™ to the participating child at least 6 times in 4 weeks. If the school is allocated to the control group, the school continues supplying the care they have been given. However, once all the data has been collected from CAU schools (after the 6 month questionnaires have been completed) the Social Stories™ training and manual are offered to CAU schools and parents.

What are the possible benefits and risks of participating?
Using the Social Stories™ may help the child with their behaviour. Participants are offered free workshops on the writing and use of Social Stories™ either as part of the intervention group or as part of the control group after data collection is completed. As a thank you for taking part the families will also receive a £20 voucher. Some parents may find talking about autism distressing. Some children may not want to read or be involved with Social Stories™. If at any time a participating child feels that the actual or perceived distress is too great they can withdraw from the study.

Where is the study run from?
Primary schools across Yorkshire and Humber.

When is the study starting and how long is it expected to run for?
July 2018 to December 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Jane Blackwell
Jane.Blackwell2@nhs.net
2. Dr Kerry Bell
Kerry.Bell@york.ac.uk
3. Dr Catarina Teige
c.teige@nhs.net
4. Prof. Barry Wright
Barry.Wright1@nhs.net


Previous plain English summary:
Background and study aims
Children with autistic spectrum disorder (ASD) have a higher prevalence of mental health problems than typically developing children, including anxiety and low mood, disruptive, and repetitive behaviours. Research shows that severe social difficulties represent a cost to the NHS and social care across childhood and adulthood (NICE, 2013; National Audit Office, 2009). Social Stories™ are purported to promote calmer classrooms with improved learning/better integration in special and mainstream education settings, and improved social behaviours. Using Social Stories™, children with ASD have shown improvements across a range of behaviours including social interaction, decision making, reduced disruptive behaviours, tantrums and frustration. The aim of this study is to find out whether Social Stories™ can improve social responsiveness in children with ASD in primary schools.

Who can participate?
Children aged 4-11 who attend a school in Yorkshire and Humber and who have a diagnosis of ASD and daily challenging behaviour

What does the study involve?
Parents and teachers complete questionnaires at three times: at the beginning of the study (baseline), six weeks into the study and six months into the study. These questionnaires collect information about demographics, the social responsiveness of the child, quality of life and health resource use. After the baseline questionnaires have been completed for all participants at the school, the school is randomly assigned to either the Social Stories™ intervention or to the control arm (which is care as usual (CAU) by the school). Assignment is decided at random by a computer and children receive all other treatment or support as usual regardless of allocation. If the school gets allocated to the intervention, a teacher is trained to write and read a Social Story™ to the participating child at least 6 times in 4 weeks. If the school is allocated to the control group, the school continues supplying the care they have been given. However, once all the data has been collected from CAU schools (after the 6 month questionnaires have been completed) the Social Stories™ training and manual are offered to CAU schools and parents.

What are the possible benefits and risks of participating?
Using the Social Stories™ may help the child with their behaviour. Participants are offered free workshops on the writing and use of Social Stories™ either as part of the intervention group or as part of the control group after data collection is completed. As a thank you for taking part the families will also receive a £20 voucher. Some parents may find talking about autism distressing. Some children may not want to read or be involved with Social Stories™. If at any time a participating child feels that the actual or perceived distress is too great they can withdraw from the study.

Where is the study run from?
1. West Specialist Inclusive Learning Centre
2. Newlands Primary School
3. Castleton Primary School
4. Ashfield Primary School
5. Victoria Primary School
6. Thornton Primary School
7. High Crags Primary Leadership Academy
8. Lacewood Primary School
9. Kirk Sandall Infants and Juniors Schools
10. Chiltern Primary School Hull
11. St Wilfrid's Roman Catholic Primary School
12. Embsay Church of England Primary School
13. Oatlands Community Junior School
14. Mowbray School
15. Luttons Community Primary School
16. Aspin Park Academy
17. Roecliffe Church of England Primary School
18. Riverside Community Primary School
19. Thomas Hinderwell Primary Academy
20. Sutton in Craven CP School
21. Saint Mary's Catholic Primary Voluntary Academy
22. St Augustine Webster Catholic Voluntary Academy

When is the study starting and how long is it expected to run for?
July 2018 to December 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Catarina Teige
c.teige@nhs.net
2. Prof. Barry Wright
barry.wright1@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Blackwell

ORCID ID

Contact details

COMIC research team
IT centre
Innovation Way
Science Park
Heslington
YO10 5NP
United Kingdom
+44 (0)1904 294244
Jane.blackwell2@nhs.net

Type

Scientific

Additional contact

Prof Barry Wright

ORCID ID

Contact details

COMIC research team
IT centre
Innovation Way
Science Park
Heslington
YO10 5NP
United Kingdom
+44 (0)1904 294244
barry.wright1@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

40949

Study information

Scientific title

Autism Spectrum Social Stories™ In Schools Trial 2 (ASSSIST2)

Acronym

ASSSIST2

Study hypothesis

This study is a randomised controlled trial (cluster randomised by school) to establish whether Social Stories™ are clinically and cost-effective in improving child social impairment, reducing challenging behaviour and improving social and emotional health in children with ASD in primary schools.

Hypothesis: The researchers hypothesise that Social Stories™ delivered in a school setting (>=6 times in a 4 week period) compared with the school’s standard care program will have a greater benefit to social and emotional health in children with autism spectrum disorder.

Ethics approval

Current ethics approval as of 04/07/2020:
1. Approved 03/09/2018, Department of Health Sciences' Research Governance Committee (HSRGC) (University of York, Heslington, York, YO10 5DD; +44 (0)1904 323253; stephen.holland@york.ac.uk), ref: HSRGC/2018/286/D
2. Approved 24/07/2019, HRA and Health and Care Research Wales (HCRW) (Health Research Authority, Ground Floor, Skipton House, 80 London
Road, London, SE1 6LH; hra.approval@nhs.net; approvals@wales.nhs.uk), ref: 19/NE/0237

Previous ethics approval:
Approved 03/09/2018, Department of Health Sciences' Research Governance Committee (HSRGC) (University of York, Dr Stephen Holland (Chair); Tel: +44 (0)1904 323253; Email: stephen.holland@york.ac.uk), ref: HSRGC/2018/286/D

Study design

Randomised; Both; Design type: Treatment, Education or Self-Management, Qualitative

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 the contact details to request a patient information sheet

Condition

Childhood autism

Intervention

The trial design is a cluster randomised controlled trial with an internal pilot comparing the Social Story™ intervention with care as usual. Trial participants are 4-11-year-old primary school children with a diagnosis of an autism spectrum disorder. The planned sample size is 278 and the primary follow-up will be 6 months post randomisation.

Social Stories intervention
Participating children allocated to the intervention group will have a Social Story™ delivered to them by a teacher or TA professionally trained in Social Stories™ (the interventionist) for a period of approximately 4 weeks alongside their usual care which is likely to vary between schools. The interventionist will deliver the Social Story™ at least 6 times in this 4-week period. The Social Stories™ will be delivered by an educational professional (the interventionist) who is employed by each school allocated to the intervention arm. The interventionist will attend a Social Stories™ training session with our research team providing information on their design and implementation. The schools randomised to the intervention will also be provided with a Social Stories™ training manual. Parents of children randomised to the intervention arm will also be invited to attend these sessions to help with story construction (though this is not a requirement for participation). During the training session the interventionist will construct a Social Story™ with input from the research team.

Care as usual
The children in the comparator arm will receive care as usual (CAU) only. CAU will vary between schools but is likely to include a range of classroom interventions built into a child’s learning plan (e.g. picture exchange communication system). The researchers will collect information as to what care has been received in both groups systematically at all timepoints using a resource use case report form. Once the last of the data has been collected from CAU schools (after 6 months), the training and manual described above will be offered to the parents and teachers who are interested.

The trial period is 42 months. The researchers collect data at baseline, 6 weeks after randomisation, and 6 months after randomisation for both treatment arms. There will be an internal pilot study which will run for 10 months to examine the feasibility of recruitment. The pilot period will run for 10 months, at which point the researchers expect to have recruited n=110 of which one third (n=44) will have reached the primary endpoint. Stop/Go criteria based on 100% of the recruitment target will be used to assess the feasibility of continuing the trial. There will be a nested economic evaluation, process evaluation, qualitative component and fidelity assessment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Child social responsiveness measured using the Social Responsiveness Scale, Second Edition (SRS-2)

Secondary outcome measures

1. Challenging behaviours measured using a bespoke goal-based outcome measure (validated with blinded observation of 20% of participants in a classroom setting by research assistants at 6 weeks and at 6 months) at 6 months
2. Social and emotional health measured using Revised Children Anxiety and Depression Scale (RCADS) short form at 6 months
3. Cost-effectiveness of Social Stories™ measured using a bespoke resource use questionnaire at 6 months
4. Health-related quality of life measured using a bespoke health care resource use questionnaire and EQ-5D-Y proxy at 6 months
5. Parental stress levels measured using Parental Stress Index (PSI) short form at 6 months
6. Classroom attendance and out of area placements measured using a bespoke questionnaire to determine current school care/education plan interventions and support provided to the child in class at 6 months
7. Sustainability of Social Stories™ measured using a bespoke Social Stories™ sustainability questionnaire at 6 months
8. Treatment preference measured using a bespoke preference questionnaire prior to randomisation at baseline
9. Session delivery measured using a bespoke Social Stories™ session log capturing frequency, length and times; problems or adverse events in the context of delivery at 6 weeks

Overall trial start date

03/07/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 4-11 years
2. Attends a school in Yorkshire and Humber
3. Has a research diagnostic criteria diagnosis of ASD and daily challenging behaviour

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 278; UK Sample Size: 278

Participant exclusion criteria

1. The school has used Social Stories™ for the child in the current or preceding school term
2. The child or interventionist teacher has taken part in the ASSSIST feasibility study. The study will not exclude schools that have taken part

Recruitment start date

01/10/2018

Recruitment end date

31/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Specialist Inclusive Learning Centre
4 Town Street
Pudsey
LS28 6HL
United Kingdom

Trial participating centre

Newlands Primary School
Wakefield Road
Normanton
WF6 1BB
United Kingdom

Trial participating centre

Castleton Primary School
Green Lane
Leeds
LS12 1JZ
United Kingdom

Trial participating centre

Ashfield Primary School
Ceston Lane
Otley
LS21 2DF
United Kingdom

Trial participating centre

Victoria Primary School
Cartmel Road
Keighley
BD21 2RD
United Kingdom

Trial participating centre

Thornton Primary School
Thornton Road
Bradford
BD13 3NN
United Kingdom

Trial participating centre

High Crags Primary Leadership Academy
Crag Road
Shipley
BD18 2ES
United Kingdom

Trial participating centre

Lacewood Primary School
Carr Head Lane
Rotherham
S63 8DA
United Kingdom

Trial participating centre

Kirk Sandall Infants and Juniors Schools
Queen Mary Crescent
Doncaster
DN3 1JT
United Kingdom

Trial participating centre

Chiltern Primary School Hull
Chiltern Street
Hull
HU3 3PL
United Kingdom

Trial participating centre

St Wilfrid's Roman Catholic Primary School
Monkgate
York
YO31 7PB
United Kingdom

Trial participating centre

Embsay Church of England Primary School
Pasture Road
Skipton
BD23 6RH
United Kingdom

Trial participating centre

Oatlands Community Junior School
Beechwood Grove
Harrogate
HG2 8QP
United Kingdom

Trial participating centre

Mowbray School
Masham Road
Bedale
DL8 2SD
United Kingdom

Trial participating centre

Luttons Community Primary School
West Lutton
Malton
YO17 8TF
United Kingdom

Trial participating centre

Aspin Park Academy
Wetherby Road
Knaresborough
HG5 8LQ
United Kingdom

Trial participating centre

Roecliffe Church of England Primary School
Roecliffe
York
YO51 9NB
United Kingdom

Trial participating centre

Riverside Community Primary School
Wetherby Road
Tadcaster
LS24 9JN
United Kingdom

Trial participating centre

Thomas Hinderwell Primary Academy
Seamer Road
Scarborough
YO12 4HF
United Kingdom

Trial participating centre

Sutton in Craven CP School
Bridge Road
Keighley
BD20 7ES
United Kingdom

Trial participating centre

Saint Mary's Catholic Primary Voluntary Academy
Wellington Street
Grimsby
DN32 7JX
United Kingdom

Trial participating centre

St Augustine Webster Catholic Voluntary Academy
Bailden Road
Scunthorpe
DN15 8BU
United Kingdom

Trial participating centre

Signhills Infant Academy and Signhills Academy
33 Hardys Road
Cleethorpes
DN35 0DL
United Kingdom

Trial participating centre

Lisle Marsden Church of England Primary Academy
Lansdowne Avenue
Grismby
DN32 0DF
United Kingdom

Trial participating centre

Castle Academy
Station Road Conisbrough
Doncaster
DN12 3DB
United Kingdom

Trial participating centre

Brinsworth Whitehill Primary School
Howlett Dr
Brinsworth
S60 5HT
United Kingdom

Trial participating centre

East Dene Primary
Doncaster Rd
Rotherham
S65 2DF
United Kingdom

Trial participating centre

Scawsby Saltersgate Infant School
Windsor Walk
Doncaster
DN5 8NQ
United Kingdom

Trial participating centre

Seamer and Irton Community Primary School
Denison Avenue Seamer
Scarborough
YO12 4QX
United Kingdom

Trial participating centre

Whitley and Eggborough Community Primary School
Learning Lane
Goole
DN14 0WE
United Kingdom

Trial participating centre

Friarage Community Primary School
Friargate
Scarborough
YO11 1HS
United Kingdom

Trial participating centre

Cockburn Haig Road Academy
Haigh Road Rothwell
Leeds
LS26 0NQ
United Kingdom

Trial participating centre

Manston St James Primary Academy
Sandbed Lane
Leeds
LS15 8JH
United Kingdom

Trial participating centre

Windmill Church of England Primary School
Upper Batley Lane
Batley
WF17 0NP
United Kingdom

Trial participating centre

Oxspring Primary School
Sheffield Road Oxspring
Sheffield
S36 8YW
United Kingdom

Trial participating centre

Athelstan Primary School
Richmond Park Way
Sheffield
S13 8HH
United Kingdom

Trial participating centre

Wetwang Church of England Primary School
21 Pulham Lane
Driffield
YO25 9XT
United Kingdom

Trial participating centre

Stokesley Primary Academy
5 Springfield Stokesley
Middlesborough
TS9 5EW
United Kingdom

Trial participating centre

Our Lady of Sorrows Catholic Voluntary Academy
Mere Lane Armthorpe
Doncaster
DN3 2DB
United Kingdom

Trial participating centre

St Martins C of E Primary School
Holbeck Hill
Scarborough
YO11 3BW
United Kingdom

Trial participating centre

Hunter's Bar Junior School
371 Sharrow Vale
Sheffield
S11 8ZG
United Kingdom

Trial participating centre

Bishopthorpe Infants School
Sim Balk Lane Bishopthorpe
York
YO23 2QQ
United Kingdom

Trial participating centre

Southcoates Primary School
Southcoates Lane
Hull
HU9 3TW
United Kingdom

Trial participating centre

Braeburn Primary and Nursery Academy
Eastfield
Scarborough
YO11 3LG
United Kingdom

Trial participating centre

East Whitby Academy
Stainsacre Lane
Whitby
YO22 4HU
United Kingdom

Trial participating centre

North Cave C of E Primary School
Station Road North Cave
Hull
HU15 2LA
United Kingdom

Trial participating centre

Pocklington Juniors
65 Kirkland Street Pocklington
York
YO42 2BX
United Kingdom

Trial participating centre

Beverley Minster Primary School
St Gile's Croft
Beverley
HU17 8LA
United Kingdom

Trial participating centre

Cawthorne Primary School
Taylor Hill Cawthorne
Barnsley
S75 4HB
United Kingdom

Trial participating centre

Queens Road Academy
Queens Road
Barnsley
S71 1AR
United Kingdom

Trial participating centre

Bay Primary School
St Alan Road
Bridlington
YO16 7SZ
United Kingdom

Trial participating centre

Brompton Community Primary School
Station Road Brompton
Northallerton
DL6 2RE
United Kingdom

Trial participating centre

Market Weighton Infant School
Princess Road
Market Weighton
YO43 3EY
United Kingdom

Trial participating centre

Colburn Community Primary School
Colburn Lane
Colburn
DL9 4LS
United Kingdom

Trial participating centre

Brandesburton Primary School
Main Street Brandesburton
East Yorkshire
YO25 9RG
United Kingdom

Trial participating centre

Tees, Esk & Wear Valley NHS Foundation Trust
York
YO30 4XT
United Kingdom

Trial participating centre

Humber Teaching NHS Foundation Trust
Hull
HU10 6ED
United Kingdom

Trial participating centre

Bradford District Care NHS Foundation Trust
Bradford
BD18 3LD
United Kingdom

Trial participating centre

Harrogate and District NHS Foundation Trust
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom

Trial participating centre

Thorpe Primary School
Dolphin Lane Thorpe
Wakefield
WF3 3DG
United Kingdom

Trial participating centre

Glasshoughton Infant Academy
Newfield Avenue
Castleford
WF10 4BH
United Kingdom

Trial participating centre

Shire Oak CE Primary School
Wood Lane Headingley
Leeds
LS6 2DT
United Kingdom

Trial participating centre

St. Joseph’s Catholic Primary School
Barleyfields Road Wetherby
West Yorkshire
LS22 6PR
United Kingdom

Trial participating centre

The John Curwen Cooperative Primary
Leeds Old Road Heckmondwike
Kirklees
WF16 9BB
United Kingdom

Trial participating centre

Kirk Sandall Infants and Juniors Schools
Queen Mary Crescent Kirk Sandall
Doncaster
DN3 1JT
United Kingdom

Trial participating centre

Newman School
East Bawtry Road
Rotherham
S60 3LX
United Kingdom

Trial participating centre

Carterknowle Junior School
Carterknowle Road
Sheffield
S7 2DY
United Kingdom

Trial participating centre

Dobcroft Junior and Infant School
Pingle Road
Sheffield
S7 2LN
United Kingdom

Trial participating centre

St Marie's School a Catholic Voluntary Academy
Fullwood Road
Sheffield
S10 3DQ
United Kingdom

Trial participating centre

Hatfield Academy - Astrea Academy Trust
Hatfield House Lane
Sheffield
S5 6HY
United Kingdom

Trial participating centre

Pocklington C.E (VC) Infant School
Maxwell Road Pocklington
York
YO42 2HE
United Kingdom

Trial participating centre

Ralph Butterfield Primary School
Station Road Haxby
York
YO32 3LS
United Kingdom

Trial participating centre

Burton Green Primary School
Burton Green
York
YO30 6JE
United Kingdom

Trial participating centre

Clifton Green Primary
Water Lane
York
YO30 6JA
United Kingdom

Trial participating centre

Pickering Community Junior School
Middleton Road
Pickering
YO18 8AJ
United Kingdom

Trial participating centre

Kettlesing Ripley and Beckwithshaw Primary Schools
Kettlesing
Harrogate
HG3 2LB
United Kingdom

Trial participating centre

Kirk Fenton Parochial Primary School
Main Street Church Fenton
Tadcaster
LS24 9RF
United Kingdom

Trial participating centre

St Mary's Catholic Primary School
Knaresborough Tentergate Road
Knaresborough
HG5 9BG
United Kingdom

Trial participating centre

Grove Road Community Primary School
Grove Road
Harrogate
HG3 3RW
United Kingdom

Trial participating centre

Burton Leonard Church of England (VC) Primary School
Burton Leonard
Harrogate
HG3 3RW
United Kingdom

Trial participating centre

Holy Trinity Junior and Infant Schools
Church Lane Ripon
North Yorkshire
HG4 2ES
United Kingdom

Sponsor information

Organisation

Leeds and York Partnership NHS Foundation Trust

Sponsor details

c/o Alison Thompson
Head of Research & Development
Leeds
LS15 8ZB
United Kingdom
+44 (0)11385 52360
athompson11@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/111/91

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The research team has a strong track record of successful dissemination of work funded by the NIHR and other funding bodies. They will begin to consider their dissemination strategy at an early stage of the project. They will publish the results of each phase of the study in high profile mainstream and specialist science journals, such as the British Journal of Psychiatry, the Journal of Child Psychology and Psychiatry, Clinical Child Psychology and Psychiatry and Journal of Autism and Developmental Disorders, and intend to publish main outcomes by 2021/2022.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository and will be included in the subsequent results publication.

Intention to publish date

31/12/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32532354/ (added 15/06/2020)

Publication citations

Additional files

Editorial Notes

06/07/2020: The following changes have been made: 1. A scientific contact has been updated. 2. The trial participating centres "Thorpe Primary School", "Glasshoughton Infant Academy", "Shire Oak CE Primary School", "St. Joseph’s Catholic Primary School", "The John Curwen Cooperative Primary", "Kirk Sandall Infants and Juniors Schools", "Newman School", "Carterknowle Junior School", "Dobcroft Junior and Infant School", "St Marie's School A Catholic Voluntary Academy", "Hatfield Academy - Astrea Academy Trust", "Pocklington C.E (VC) Infant School", "Ralph Butterfield Primary School", "Burton Green Primary School", "Clifton Green Primary", "Pickering Community Junior School", "Kettlesing Ripley and Beckwithshaw Primary Schools", "Kirk Fenton Parochial Primary School", "St Mary's Catholic Primary School", "Grove Road Community Primary School", "Burton Leonard Church of England (VC) Primary School", and "Holy Trinity Junior and Infant Schools " have been added. 04/07/2020: The following changes have been made: 1. The ethics approval has been updated. 2. The target number of participants has been changed from "Planned Sample Size: 276; UK Sample Size: 276" to "Planned Sample Size: 278; UK Sample Size: 278". 3. The total target enrolment number has been changed from 276 to 278. 4. The trial participating centres "Signhills Infant Academy and Signhills Academy", "Lisle Marsden Church of England Primary Academy", "Castle Academy", "Brinsworth Whitehill Primary School", "East Dene Primary", "Scawsby Saltersgate Infant School", "Seamer and Irton Community Primary School", "Whitley and Eggborough Community Primary School", "Friarage Community Primary School", "Cockburn Haig Road Academy", "Manston St James Primary Academy", "Windmill Church of England Primary School", "Oxspring Primary School", "Athelstan Primary School", "Wetwang Church of England Primary School", "Stokesley Primary Academy", "Our Lady of Sorrows Catholic Voluntary Academy", "St Martins C of E Primary School", "Hunter's Bar Junior School", "Bishopthorpe Infants School", "Southcoates Primary School", "Braeburn Primary and Nursery Academy", "East Whitby Academy", "North Cave C of E Primary School", "Pocklington Juniors", "Beverley Minster Primary School", "Cawthorne Primary School", "Queens Road Academy", "Bay Primary School", "Brompton Community Primary School", "Market Weighton Infant School", "Colburn Community Primary School", "Brandesburton Primary School", "Tees, Esk & Wear Valley NHS Foundation Trust", "Humber Teaching NHS Foundation Trust", "Bradford District Care NHS Foundation Trust", "Harrogate and District NHS Foundation Trust", and "Sheffield Children's NHS Foundation Trust" have been added. 5. The plain English summary has been updated. 15/06/2020: Publication reference added.