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)