A primary school research study to establish whether Social Stories™ can improve social and emotional health in children with autism spectrum disorder
| ISRCTN | ISRCTN11634810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11634810 |
| Protocol serial number | 40949 |
| Sponsor | Leeds and York Partnership NHS Foundation Trust |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/111/91 |
- Submission date
- 08/04/2019
- Registration date
- 23/04/2019
- Last edited
- 08/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 May 2022
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?
Child Oriented Mental health Intervention Centre (COMIC) (UK)
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
Contact information
Scientific
COMIC research team
IT centre
Innovation Way
Science Park
Heslington
YO10 5NP
United Kingdom
| Phone | +44 (0)1904 294244 |
|---|---|
| Jane.blackwell2@nhs.net |
Scientific
COMIC research team
IT centre
Innovation Way
Science Park
Heslington
YO10 5NP
United Kingdom
| Phone | +44 (0)1904 294244 |
|---|---|
| barry.wright1@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Both; Design type: Treatment, Education or Self-Management, Qualitative |
| Secondary study design | Randomised controlled trial |
| Scientific title | Autism Spectrum Social Stories™ In Schools Trial 2 (ASSSIST2) |
| Study acronym | ASSSIST2 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Child social responsiveness measured using the Social Responsiveness Scale, Second Edition (SRS-2) |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 11 Years |
| Sex | All |
| Target sample size at registration | 278 |
| Total final enrolment | 249 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 31/05/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Pudsey
LS28 6HL
England
Normanton
WF6 1BB
England
Leeds
LS12 1JZ
England
Otley
LS21 2DF
England
Keighley
BD21 2RD
England
Bradford
BD13 3NN
England
Shipley
BD18 2ES
England
Rotherham
S63 8DA
England
Doncaster
DN3 1JT
England
Hull
HU3 3PL
England
York
YO31 7PB
England
Skipton
BD23 6RH
England
Harrogate
HG2 8QP
England
Bedale
DL8 2SD
England
Malton
YO17 8TF
England
Knaresborough
HG5 8LQ
England
York
YO51 9NB
England
Tadcaster
LS24 9JN
England
Scarborough
YO12 4HF
England
Keighley
BD20 7ES
England
Grimsby
DN32 7JX
England
Scunthorpe
DN15 8BU
England
Cleethorpes
DN35 0DL
England
Grismby
DN32 0DF
England
Conisbrough
Doncaster
DN12 3DB
England
Brinsworth
S60 5HT
England
Rotherham
S65 2DF
England
Doncaster
DN5 8NQ
England
Seamer
Scarborough
YO12 4QX
England
Goole
DN14 0WE
England
Scarborough
YO11 1HS
England
Rothwell
Leeds
LS26 0NQ
England
Leeds
LS15 8JH
England
Batley
WF17 0NP
England
Oxspring
Sheffield
S36 8YW
England
Sheffield
S13 8HH
England
Driffield
YO25 9XT
England
Stokesley
Middlesborough
TS9 5EW
England
Armthorpe
Doncaster
DN3 2DB
England
Scarborough
YO11 3BW
England
Sheffield
S11 8ZG
England
Bishopthorpe
York
YO23 2QQ
England
Hull
HU9 3TW
England
Scarborough
YO11 3LG
England
Whitby
YO22 4HU
England
North Cave
Hull
HU15 2LA
England
Pocklington
York
YO42 2BX
England
Beverley
HU17 8LA
England
Cawthorne
Barnsley
S75 4HB
England
Barnsley
S71 1AR
England
Bridlington
YO16 7SZ
England
Brompton
Northallerton
DL6 2RE
England
Market Weighton
YO43 3EY
England
Colburn
DL9 4LS
England
Brandesburton
East Yorkshire
YO25 9RG
England
York
YO30 4XT
England
Hull
HU10 6ED
England
Bradford
BD18 3LD
England
Harrogate
HG2 7SX
England
Sheffield
S10 2TH
England
Thorpe
Wakefield
WF3 3DG
England
Castleford
WF10 4BH
England
Headingley
Leeds
LS6 2DT
England
Wetherby
West Yorkshire
LS22 6PR
England
Heckmondwike
Kirklees
WF16 9BB
England
Kirk Sandall
Doncaster
DN3 1JT
England
Rotherham
S60 3LX
England
Sheffield
S7 2DY
England
Sheffield
S7 2LN
England
Sheffield
S10 3DQ
England
Sheffield
S5 6HY
England
Pocklington
York
YO42 2HE
England
Haxby
York
YO32 3LS
England
York
YO30 6JE
England
York
YO30 6JA
England
Pickering
YO18 8AJ
England
Harrogate
HG3 2LB
England
Church Fenton
Tadcaster
LS24 9RF
England
Knaresborough
HG5 9BG
England
Harrogate
HG3 3RW
England
Harrogate
HG3 3RW
England
Ripon
North Yorkshire
HG4 2ES
England
Leeds
LS26 8RD
England
Scunthorpe
DN16 2HY
England
Sheffield
S5 9QN
England
North Allerton
DL7 9NQ
England
Fulford
York
YO10 4LX
England
Stamford Bridge
YO41 1BP
England
Bingley
BD16 1HB
England
Crossflatts
Bingley
BD16 2EP
England
Sheffield
S12 4HJ
England
Norton-on-Derwent
Malton
YO17 9BG
England
Hull
HU7 4AH
England
Norland Avenue
Hull
HU4 7ST
England
South Bank
York
YO23 1HY
England
Cleethorpes
DN35 8UL
England
Adwick le Street
Doncaster
DN6 7EF
England
Hull
HU8 9JH
England
Hoyland
Barnsley
S74 9RG
England
Sheffield
S6 6HE
England
Spotbrough
DN5 7SB
England
Penistone
Barnsley
S36 6FS
England
Bradford
BD8 8HT
England
Sheffield
S17 3PT
England
Mosborough
Sheffield
S20 5ES
England
Kimberworth
Rotherham
S61 2NU
England
Meersbrook
Sheffield
S8 9EH
England
Stocksbridge
Sheffield
S36 1EJ
England
Northallerton
DL6 1RB
England
Sheffield
S2 2RU
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/08/2024 | 02/09/2024 | Yes | No | |
| Results article | 17/12/2024 | 19/12/2024 | Yes | No | |
| Results article | Cost–utility analysis | 03/06/2024 | 08/06/2026 | Yes | No |
| Protocol article | protocol | 12/06/2020 | 15/06/2020 | Yes | No |
| Abstract results | 12/07/2022 | No | No | ||
| HRA research summary | 20/09/2023 | No | No |
Additional files
- 36567 Abstract.pdf
- Abstract results
Editorial Notes
08/06/2026: Publication reference added.
19/12/2024: Publication reference added.
02/09/2024: Publication reference added.
20/09/2023: A link to the HRA research summary was added.
12/07/2022: An abstract was uploaded as an additional file.
24/05/2021: The final enrolkment number has been added.
07/05/2021: The trial participating centres Stocksbridge Nursery Infant School, Alverton Community Primary School, Holgate Meadows and Heritage Park were added.
20/04/2021: The recruitment end date was changed from 30/04/2021 to 31/05/2021.
07/04/2021: Rowan School, Mosborough, Halfway Infants and Juniors, Kelford School, and Meersbrook Bank Primary School were added as trial participating centres.
16/03/2021: The recruitment end date has been changed from 31/03/2021 to 30/04/2021.
01/03/2021: Bradfield Dungworth Primary School, The Levett School, Penistone St Johns and Green Lane Primary School were added as trial participating centres.
02/02/2021: The trial participating centres Thrunscoe Primary and Nursery Academy, North Ridge Community, Spring Cottage Primary School, Greenfield Primary School were added.
07/12/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2020 to 31/03/2021.
2. The overall trial end date has been changed from 31/12/2021 to 31/05/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2022 to 31/12/2022.
4. Woodlesford Primary School, Outwood Junior Academy Brumby, Woolley Wood Primary, Leeming RAF Community Primary School, St Oswald's CE Primary School, Stamford Bridge Primary School, Myrtle Park Primay School, Crossflatts Primary School, St John Fisher Primary School, Norton Community Primary School, Sutton Park Primary School, Acre Heads Primary School and Knavesmire Primary School have been added to the trial participating centres.
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.
