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 |
| Secondary identifying numbers | 40949 |
- Submission date
- 08/04/2019
- Registration date
- 23/04/2019
- Last edited
- 19/12/2024
- 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
| Study design | Randomized; Both; Design type: Treatment, Education or Self-Management, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 | 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 study start date | 03/07/2018 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 278; UK Sample Size: 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
- England
- United Kingdom
Study participating centres
Pudsey
LS28 6HL
United Kingdom
Normanton
WF6 1BB
United Kingdom
Leeds
LS12 1JZ
United Kingdom
Otley
LS21 2DF
United Kingdom
Keighley
BD21 2RD
United Kingdom
Bradford
BD13 3NN
United Kingdom
Shipley
BD18 2ES
United Kingdom
Rotherham
S63 8DA
United Kingdom
Doncaster
DN3 1JT
United Kingdom
Hull
HU3 3PL
United Kingdom
York
YO31 7PB
United Kingdom
Skipton
BD23 6RH
United Kingdom
Harrogate
HG2 8QP
United Kingdom
Bedale
DL8 2SD
United Kingdom
Malton
YO17 8TF
United Kingdom
Knaresborough
HG5 8LQ
United Kingdom
York
YO51 9NB
United Kingdom
Tadcaster
LS24 9JN
United Kingdom
Scarborough
YO12 4HF
United Kingdom
Keighley
BD20 7ES
United Kingdom
Grimsby
DN32 7JX
United Kingdom
Scunthorpe
DN15 8BU
United Kingdom
Cleethorpes
DN35 0DL
United Kingdom
Grismby
DN32 0DF
United Kingdom
Conisbrough
Doncaster
DN12 3DB
United Kingdom
Brinsworth
S60 5HT
United Kingdom
Rotherham
S65 2DF
United Kingdom
Doncaster
DN5 8NQ
United Kingdom
Seamer
Scarborough
YO12 4QX
United Kingdom
Goole
DN14 0WE
United Kingdom
Scarborough
YO11 1HS
United Kingdom
Rothwell
Leeds
LS26 0NQ
United Kingdom
Leeds
LS15 8JH
United Kingdom
Batley
WF17 0NP
United Kingdom
Oxspring
Sheffield
S36 8YW
United Kingdom
Sheffield
S13 8HH
United Kingdom
Driffield
YO25 9XT
United Kingdom
Stokesley
Middlesborough
TS9 5EW
United Kingdom
Armthorpe
Doncaster
DN3 2DB
United Kingdom
Scarborough
YO11 3BW
United Kingdom
Sheffield
S11 8ZG
United Kingdom
Bishopthorpe
York
YO23 2QQ
United Kingdom
Hull
HU9 3TW
United Kingdom
Scarborough
YO11 3LG
United Kingdom
Whitby
YO22 4HU
United Kingdom
North Cave
Hull
HU15 2LA
United Kingdom
Pocklington
York
YO42 2BX
United Kingdom
Beverley
HU17 8LA
United Kingdom
Cawthorne
Barnsley
S75 4HB
United Kingdom
Barnsley
S71 1AR
United Kingdom
Bridlington
YO16 7SZ
United Kingdom
Brompton
Northallerton
DL6 2RE
United Kingdom
Market Weighton
YO43 3EY
United Kingdom
Colburn
DL9 4LS
United Kingdom
Brandesburton
East Yorkshire
YO25 9RG
United Kingdom
YO30 4XT
United Kingdom
HU10 6ED
United Kingdom
BD18 3LD
United Kingdom
HG2 7SX
United Kingdom
S10 2TH
United Kingdom
Thorpe
Wakefield
WF3 3DG
United Kingdom
Castleford
WF10 4BH
United Kingdom
Headingley
Leeds
LS6 2DT
United Kingdom
Wetherby
West Yorkshire
LS22 6PR
United Kingdom
Heckmondwike
Kirklees
WF16 9BB
United Kingdom
Kirk Sandall
Doncaster
DN3 1JT
United Kingdom
Rotherham
S60 3LX
United Kingdom
Sheffield
S7 2DY
United Kingdom
Sheffield
S7 2LN
United Kingdom
Sheffield
S10 3DQ
United Kingdom
Sheffield
S5 6HY
United Kingdom
Pocklington
York
YO42 2HE
United Kingdom
Haxby
York
YO32 3LS
United Kingdom
York
YO30 6JE
United Kingdom
York
YO30 6JA
United Kingdom
Pickering
YO18 8AJ
United Kingdom
Harrogate
HG3 2LB
United Kingdom
Church Fenton
Tadcaster
LS24 9RF
United Kingdom
Knaresborough
HG5 9BG
United Kingdom
Harrogate
HG3 3RW
United Kingdom
Harrogate
HG3 3RW
United Kingdom
Ripon
North Yorkshire
HG4 2ES
United Kingdom
Leeds
LS26 8RD
United Kingdom
Scunthorpe
DN16 2HY
United Kingdom
Sheffield
S5 9QN
United Kingdom
North Allerton
DL7 9NQ
United Kingdom
Fulford
York
YO10 4LX
United Kingdom
Stamford Bridge
YO41 1BP
United Kingdom
Bingley
BD16 1HB
United Kingdom
Crossflatts
Bingley
BD16 2EP
United Kingdom
Sheffield
S12 4HJ
United Kingdom
Norton-on-Derwent
Malton
YO17 9BG
United Kingdom
Hull
HU7 4AH
United Kingdom
Norland Avenue
Hull
HU4 7ST
United Kingdom
South Bank
York
YO23 1HY
United Kingdom
Cleethorpes
DN35 8UL
United Kingdom
Adwick le Street
Doncaster
DN6 7EF
United Kingdom
Hull
HU8 9JH
United Kingdom
Hoyland
Barnsley
S74 9RG
United Kingdom
Sheffield
S6 6HE
United Kingdom
Spotbrough
DN5 7SB
United Kingdom
Penistone
Barnsley
S36 6FS
United Kingdom
Bradford
BD8 8HT
United Kingdom
Sheffield
S17 3PT
United Kingdom
Mosborough
Sheffield
S20 5ES
United Kingdom
Kimberworth
Rotherham
S61 2NU
United Kingdom
Meersbrook
Sheffield
S8 9EH
United Kingdom
Stocksbridge
Sheffield
S36 1EJ
United Kingdom
Northallerton
DL6 1RB
United Kingdom
Sheffield
S2 2RU
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Alison Thompson
Head of Research & Development
Leeds
LS15 8ZB
England
United Kingdom
| Phone | +44 (0)11385 52360 |
|---|---|
| athompson11@nhs.net | |
"ROR" |
https://ror.org/00n635c12 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| 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 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? |
|---|---|---|---|---|---|
| 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 | ||
| Results article | 31/08/2024 | 02/09/2024 | Yes | No | |
| Results article | 17/12/2024 | 19/12/2024 | Yes | No |
Additional files
Editorial Notes
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.
