Wright et al.

BMC Psychology (2020) 8:60

https://doi.org/10.1186/s40359-020-00427-z

STUDY PROTOCOL Open Access

Autism Spectrum Social Stories In Schools

Trial 2 (ASSSIST2): study protocol for a
randomised controlled trial analysing
clinical and cost-effectiveness of Social
Stories™ in primary schools
B. Wright1,2,3*, C. Teige1, J. Watson4, R. Hodkinson1, D. Marshall5, D. Varley6, V. Allgar6, L. Mandefield4, S. Parrott6,
E. Kingsley1, R. Hargate1, N. Mitchell4, S. Ali6,7, D. McMillan6, H. Wang6 and C. Hewitt4

Abstract
Background: Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC)
can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised
intervention aiming to give children with ASC social information or describing an otherwise difficult situation or
skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded
mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs).
Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely.
Methods: A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This
study will recruit 278 participants (aged 4–11) with a clinical diagnosis of ASC, currently attending primary school in
the North of England. Approximately 278 school based staff will be recruited to provide school based information
about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster
randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow
up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants’
social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the
Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have
been obtained from the University of York’s Research Governance Committee, Research Ethics Committee and the
Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and
disseminated to participating families, educational staff, local authority representatives, community groups and
Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence
dependent on findings.
(Continued on next page)

* Correspondence: barry.wright1@nhs.net
1
Child Oriented Mental Health Intervention Centre, Leeds and York
Partnership NHS Foundation Trust, York, UK
2
Hull York Medical School, University of York, York, UK
Full list of author information is available at the end of the article

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Wright et al. BMC Psychology (2020) 8:60 Page 2 of 10

(Continued from previous page)

Discussion: This study addresses a much used but currently under researched intervention and results will inform
school based support for primary school children with a diagnosis of ASC.
Trial registration: The trial is registered on the ISRCTN registry (registration number: ISRCTN11634810). The trial
was retrospectively registered on 23rd April 2019.
Keywords: Social stories, Autism Spectrum conditions, School based interventions, Child mental health, Education

Background [25]. Success has also been reported in reducing tantrums

Autism Spectrum Disorders, often termed Autism [26, 27] and managing frustration [28]. This research also
Spectrum Conditions (ASC) [1] affects at least 1% of chil- suggests that it is possible to train tier one professionals,
dren in the UK [2]. ASC is a lifelong neurodevelopmental for example teachers, to develop and use Social Stories™
condition that can impact upon a range of child and adult tailored to a child [29].
outcomes [3, 4]. Children with ASC have a range of difficul- Despite this research, two systematic reviews of their
ties with social communication, sensory processing differ- effectiveness [30, 31] indicate large gaps in the literature.
ences, and may have repetitive behaviours [5] and/or The reviews mainly identify single case designs and a
preoccupations [6]. They experience a higher prevalence of lack of randomised controlled trial evidence.
mental health problems than typically developing children This research is needed now because numerous
including anxiety and low mood [7]. Many children with schools utilise Social Stories™ despite a limited evidence
ASC struggle to manage social anxiety and feelings of frus- base. This is highly relevant when many providers face
tration, which can lead to challenging behaviour [8–10]. Re- limited resources for children with neurodevelopmental
search shows that many people with ASC have additional problems and mental health problems. Given that spe-
care needs, both in the NHS and social care across child- cialist practitioner interventions are in short supply, in-
hood and adulthood [11, 12]. terventions such as Social Stories™ deserve robust
Social norms and classroom expectations can be diffi- evaluation as they can be delivered within schools on a
cult for children with ASC to learn and understand [13] day to day basis. We will be exploring these aspects
and teachers facing many demands on their time and within our study. This study follows an RCT that
with limited training opportunities, may struggle to sup- assessed the feasibility and acceptability of running a
port their education [14]. trial examining Social Story™ use in both primary and
Carol Gray’s Social Stories™ are short, highly individua- secondary mainstream schools [32]. This demonstrated a
lised stories that provide children with social information. high degree of acceptability with young people, family
They help children with ASC more easily understand a and schools. This main trial now seeks to assess the clin-
situation personal to them such as learning life skills, new ical and cost-effectiveness of Social Stories™, addressing
experiences, understanding emotions (or people), transi- the lack of fully powered RCTs in this area.
tions or change. The child is included in the narrative
often with a range of helpful visual information. They are
child friendly and do not require extensive involvement Study aim
from outside experts [15]. Social Stories™ are defined by To assess the clinical and cost-effectiveness of Social
ten criteria that guide story development [16]. These help Stories™ alongside care as usual in primary schools when
to ensure stories remain patient and supportive in tone compared with care as usual alone.
using relevant, tailored content that is descriptive, mean-
ingful, and safe for the child. The capacity for tailoring
these stories is particularly important for helping children Study objectives
with ASC across a range of ages, strengths, difficulties and Primary
needs [17, 18]. Previous research examining Social Story™ The primary objective of the study is to establish
use in specialist and mainstream education [19, 20] and whether Social Stories™ can improve social responsive-
within the home [18] shows largely positive results [21], ness in children with ASC in primary schools across
and suggests that Social Stories™ may promote calmer Yorkshire and the Humber, when compared to children
classrooms with improved learning and better integration who have received care as usual only.
in Special Educational Needs (SEN) [19] and mainstream
settings [20]. Children with ASC have shown improve-
ments in social interactions [22–24], decision making [23], Secondary
self awareness in communication [24] and mealtime skills The secondary objectives of this trial are:
Wright et al. BMC Psychology (2020) 8:60 Page 3 of 10

1. To investigate whether Social Stories™ can reduce  Parents/guardians of the child are able to self-
challenging behaviour in children with ASC in complete the English language outcome measures
primary schools. (with assistance if necessary).
2. To investigate whether Social Stories™ can improve
social and emotional health in children with ASC in Exclusion criteria:
primary schools.
3. To assess the cost-effectiveness of Social Stories™.  The school has used Social Stories™ for any pupil in
4. To examine the effects of Social Stories™ delivered the current or preceding school term.
in the classroom on general measures of health  The child or interventionist teacher has taken part
related quality of life. in the previous Social Stories™ feasibility study
5. To examine whether Social Stories™ improve (ASSSIST). Schools that have taken part will not be
classroom attendance. excluded.
6. To assess sustainability of Social Stories™ in an
education setting across a 6 month period.
7. To examine any changes in parental stress. Intervention
8. To examine any associations between treatment Children in the intervention arm of the trial will receive
preference and outcomes. the Social Stories™ intervention in addition to their care
9. To examine how elements of session delivery (e.g. as usual.
session frequency, length and any associated The Social Stories™ intervention will be delivered by a
problems/adverse events) are associated with trained educational professional (the interventionist) who
outcomes. is employed within each school allocated to the interven-
tion arm. The interventionist may vary between the
Trial design schools (e.g. a teacher, teaching assistant (TA), or Special
This trial is a multi-site pragmatic cluster RCT compar- Educational Needs Coordinator (SENCO)). Social Stories™
ing Social Stories™ and care as usual with a control used within the trial will be based on a goal developed
group receiving care as usual alone. Care as usual is de- mainly by an education professional who knows the par-
fined as the existing support routinely provided for a ticipating child well but is not the interventionist (the as-
child with ASC from educational and health services sociated teacher). This goal will be developed with
such as specialist autism teacher teams, mental health support from the study team; and where possible the par-
teams or other associated professionals. The trial in- ent/guardian, interventionist and the child. A Social Story™
cludes a 10 month internal pilot, a process evaluation is used to provide a child with social information and
(including qualitative interviews and an examination of works well if a child is uncertain or finds a situation dis-
treatment fidelity) and an economic evaluation. tressing, frustrating or incomprehensible.
Interventionists will be trained by the research team or
Methods through trained local authority autism specialist staff.
Study setting Training will include information on the design and im-
Participants will be recruited using a variety of methods plementation of Social Stories™, with materials based on
including identification through schools, or identification those developed in the preceding feasibility study with
through participating NHS trusts using their clinic lists/ the support of Carol Gray [32] and a Social Stories™
databases. Intervention delivery will take place in the manual produced by the study’s Chief Investigator (CI)
participant’s school. and a Clinical Psychologist with expertise in autism [33].
During the training session, interventionists will con-
Eligibility criteria struct a Social Story™. Parents/guardians will also be in-
Both the school and the child’s parents/guardians must vited to attend these sessions. Following training all
agree to take part before either may be included. Eligibil- Social Stories™ will be assessed against a fidelity check-
ity to take part will be ascertained using the following list, to ensure they conform to the ten established cri-
criteria. teria [16, 33]. They will then be delivered to children in
Inclusion criteria: the intervention arm by the interventionist at least six
times over a 4 week period.
 The child is aged 4–11 years. Goal based outcome measures will be used and 20 %
 The child attends a participating primary school of children allocated to the intervention arm will be
within Yorkshire and the Humber. observed by a blinded research assistant to ascertain
 The child has a clinical diagnosis of ASC and daily their progress towards the goal. Consent to these
challenging behaviour. observations will be optional and participants will be
Wright et al. BMC Psychology (2020) 8:60 Page 4 of 10

randomly selected by the Trials Unit using a computer 4. Bespoke treatment preference questionnaire –
generated list from those who have opted in. baseline only.
5. Bespoke resource use questionnaire determining
current school care/education plan interventions –
Control
baseline and 6 months only.
Participants allocated to the control arm of the trial will
receive care as usual. Schools in the control arm are
Interventionist Teacher/ TA Questionnaires:
asked to refrain from delivering any Social Stories™ for
the duration of their trial involvement.
1. Bespoke Social Story™ session log. – used after each
If a participant decides to withdraw from the interven-
Social Story™ session.
tion and/or the study, a member of the research team
2. A bespoke sustainability questionnaire – 6 weeks
will record details including reasons provided, whether
and 6 months only.
withdrawal is from the whole study or an individual
element, and whether they wish to continue providing
Process Evaluation - Researcher Questionnaires:
data for analysis.
1. A fidelity checklist (intervention arm only) assessing
Outcomes (primary and secondary) each Social Story™ - after the story has been created
Baseline and follow-up measures will be collected during and at 6 weeks post-randomisation.
visits to schools, participants’ homes or at locations con- 2. A goal-based measure – used when observing ran-
venient to participants or via post where face to face domised children at 6 weeks and 6 months.
data collection is not possible. The primary outcome is
the Social Responsiveness Scale, Second Edition (SRS-2) Sample size calculation
[34] completed at 6 months post-randomisation by the The primary outcome is the teacher completed SRS-2 t-
associated teacher. The SRS-2 measures social inter- score at 6 months. Within the pilot data, outcomes were
action skills and ASC symptomatology. measured at 6 and 16 weeks. The correlation between
All secondary outcomes are listed below (grouped by baseline and 6 weeks (r = 0.67, 95% CI 0.44 to 0.80) was
respondent) and will be collected at baseline, 6 weeks lower than that at 16 weeks (r = 0.83, 95% CI 0.68 to
and 6 months post-randomisation unless specified. The 0.91) for the pilot data. To be conservative we have
trial flow chart is seen in Fig. 1. chosen the lower 95% confidence limit for the lowest
Parent questionnaires: correlation between baseline and follow-up that we ob-
served within our pilot data (r = 0.44). Assuming a dif-
1. Social Responsiveness Scale, Second Edition (SRS-2) ference of 3 points, SD = 7, 5% alpha, 90% power,
[34]. average cluster size 1.35, ICC = 0.34, correlation = 0.44
2. Demographic information pertaining to the child and 25% attrition requires a total sample size of 278.
and the parent – baseline only.
3. Parenting Stress Index short form [35]. Recruitment
4. The EQ-5D-Y (proxy) [36]. The study aims to recruit 278 children with ASC from
5. Revised Children Anxiety and Depression Scale across Yorkshire and the Humber. Recruitment opened
(RCADS) short form [37]. in November 2018. In addition, the study will recruit
6. Bespoke resource use questionnaire, capturing 278 parents/guardians, 278 associated teachers and ap-
healthcare and non-health resource use of partici- proximately 140 interventionists who will each complete
pants and parents/carers– baseline and 6 months study questionnaires, and in the case of interventionists,
only. deliver Social Stories™ sessions.
7. Bespoke treatment preference questionnaire – ASSSIST2 will use five methods of participant recruit-
baseline only. ment outlined in more detail below:

Associated teacher/TA questionnaires: Recruitment from schools

Primary schools across Yorkshire and the Humber will
1. Social Responsiveness Scale, Second Edition (SRS-2) be contacted with information about the trial. Where
[34]. schools agree to participate they will be asked to send
2. A goal-based outcome measure (adapted from the information sheets and Expression of Interest (EOI)
Child Outcomes Research Consortium) [38]. forms to parents/guardians of eligible children. Parents/
3. Bespoke resource use questionnaire – baseline and guardians who return an EOI form or have consented
6 months only. for school staff to pass on their details will be contacted
Wright et al. BMC Psychology (2020) 8:60 Page 5 of 10

Fig. 1 Study Flow Chart

by a member of the research team to discuss the trial, forms to the child’s parent/guardian. Recruitment will
answer any questions and to arrange collection of in- then follow the procedure set out for schools.
formed consent from parents/guardians and where pos-
sible assent from the child. We will also gain consent
from education professionals taking part in the trial. Recruitment from local community groups
Local community groups within the catchment area,
e.g. the Autism Spectrum Conditions - Enhancing
Recruitment from NHS sites Nurture and Development (ASCEND) parent group
Participating NHS Trusts who carry out autism [39], will be contacted with information about the
spectrum assessments will be asked to identify poten- trial and researchers will distribute study information
tially eligible families through screening of their clinic/ to interested parents/guardians. On receipt of an
database lists. A member of the clinic team (or delegated EOI, recruitment will follow the procedure outlined
staff member) will send study information and EOI for schools.
Wright et al. BMC Psychology (2020) 8:60 Page 6 of 10

Liaising with local authority professionals Data management

Relevant local authority professionals, e.g. educational All information collected during the study will be kept
specialists in ASC, will be contacted and asked to dis- strictly confidential and stored on a secure password
seminate study information and EOI forms to the par- protected server located at the University of York, for
ents/guardians of potentially eligible children. On receipt the purposes of assisting in follow-ups during the study.
of an EOI recruitment will follow the procedure outlined All paper documents will be stored securely.
for schools. CRFs will be initially checked for errors by the re-
search team and any queries raised immediately with
Recruitment from local publicity participants. CRFs will then be logged on the YTUs be-
Families may hear about the trial from a range of spoke data management system and scanned using Car-
sources and contact the research team. In this instance diff Teleform. Original datasheets will be securely stored
the team will confirm the child’s eligibility and send out at YTU. All data will be collected and retained in ac-
study information. It will be made clear that participa- cordance with the Data Protection Act 2018, the General
tion is dependent on the child’s school taking part and Data Protection Regulation 2018 and YTU standard op-
recruitment will continue in line with the procedure out- erating procedures (SOPs). All data will be archived for
lined for schools. 10 years following the end of the study and then securely
destroyed.
Randomisation
Randomisation will occur after consent/assent and base-
Statistical analysis
line data has been obtained from all participating fam-
Statistical analyses will be conducted using a validated
ilies and educational professionals within a school.
statistical software package and will be reported in line
Remote randomisation for the trial will be carried out by
with the Consolidated Standards of Reporting Trials
the York Trials Unit (YTU). Schools will be randomised
(CONSORT) 2010 Statement [40]. The primary analysis
using cluster randomisation to reduce the risk of con-
population will be intention to treat (ITT).
tamination within schools with multiple participating
children. Randomisation will be stratified by school type
(SEN school or mainstream school) and by the number Primary and secondary outcomes analysis
of participating children within a school (≤5 or > 5 par- The primary analysis will compare teacher reported
ticipating children). SRS-2 t-scores measured at 6 months between the ran-
Following randomisation schools will be notified of domised groups using a covariance pattern mixed model.
study allocation via phone call, email and following let- Important baseline covariates, baseline SRS-2 t-score, the
ter. Participating parents/guardians will receive a con- SEN status of the child’s school (SEN vs. non-SEN), the
firmatory letter. number of recruited children in the child’s school (> 5
vs. ≤5), time point, treatment group, and a treatment
Blinding group-by-time point interaction will be included as fixed
Research assistants collecting outcome data and the main effects and school will be included as a random effect.
trial statistician will be blinded to study allocation until final SRS-2 t-scores at 6 weeks post randomisation will be in-
data analysis. It is not possible for children, parents/guard- corporated as outcome data. The model will account for
ians or school staff to be blinded to study allocation due to the correlation of scores within pupil over time by
the nature of the intervention. The Data Monitoring and means of an appropriate covariance structure. Interven-
Ethics Committee (DMEC) will have access to un-blinded tion effects in the form of an adjusted mean difference
data throughout the study. Any instances of un-blinding will be presented with an associated 95% CI and p-value
will be recorded using a bespoke form. In such instances a for both time points (6 weeks and 6 months).
substitute blinded research assistant will collect participant Secondary outcomes will be analysed in a similar man-
data wherever possible. ner to the primary analysis, adjusting for the appropriate
baseline score being tested. The summary of Adverse
Data collection Events (AEs) and Serious Adverse Events (SAEs) experi-
Data collection will utilise paper Case Report Forms enced by participants will be reported by treatment group.
(CRFs). To maintain participant confidentiality CRFs will Subgroup analyses will be performed to explore the
be anonymised using participant ID numbers. Data collec- potential effect of teacher’s preferred randomisation
tion will occur at baseline, 6 weeks and 6 months post- group collected at baseline. The primary analysis model
randomisation. Wherever possible baseline CRFs will be will be refitted with an interaction term between the
completed in person and where not possible, participants randomisation group and teacher’s preference. A Com-
will be offered the option to return them by post. plier Average Causal Effect analysis for the primary
Wright et al. BMC Psychology (2020) 8:60 Page 7 of 10

outcome will be considered to account for compliance EQ-5D-Y (proxy version) as a health descriptor measure
with the intervention at the student level. (the preferred instrument in the NICE reference case).
The domains of the EQ-5D-Y proxy will then be valued
Process evaluation using UK population tariff to provide utility scores at
The process evaluation will include an interventionist multiple time points. QALYs will be estimated using
questionnaire, capturing how many times intervention- time weighted averages of the utility scores measured
ists have used Social Stories™; and whether they have over the study time period.
trained others. Interviews and fidelity assessment will be The cost of the Social Stories™ intervention will be cal-
carried out. A Social Story™ writing and delivery training culated using a bottom-up estimation of the time spent
DVD will be developed and an FAQ document identify- by professionals delivering the intervention, the cost of
ing elements of good practice in the implementation of training and other resources used. Unit costs of health
Social Stories™ as well as any common issues or barriers service use will be obtained from the UK national data-
highlighted by interventionists and/or parents. Both of base of reference costs. The cost of social services will
these outputs will be freely available on the research be calculated from the Unit Costs of Health and Social
team’s website. Care, produced by the Personal Social Services Research
Unit, and the cost of other professional support will be
Qualitative analysis estimated from relevant salary scales and published re-
Semi-structured interviews will be undertaken with 10–20 ports/ literature.
participants to explore challenges and barriers to training A sensitivity analysis will be conducted including costs
and implementation of Social Stories™, and the willingness of productivity loss.
of school staff to run the intervention independently.
These participants will be purposively selected from the Data monitoring
cohort of teachers, trainers, interventionists, Associated The conduct of the study will be governed by three
Teachers, local authority representatives involved in the committees.
trial and parents who attended the training. With consent,
all interviews will be recorded on encrypted devices, tran-  A Trial Steering Committee (TSC).
scribed verbatim and anonymised. A sample of data  An independent Data Monitoring and Ethics
transcripts will be checked against audio recordings for Committee (DMEC).
accuracy. Interview material will be organised according  A Trial Management Group (TMG).
to analytical headings using a constant comparison ap-
proach [41]. Qualitative data analysis computer software These committees will function in accordance with
will be used to structure and explore the interview data. YTU SOPs. The DMEC and TSC are both independent
Electronic sound files and transcripts from qualitative in- from the sponsor. The TSC will consist of an independ-
terviews will be assigned a unique participant number, ent chair, an independent subject specialist, an inde-
known only to relevant members of the research team. pendent clinical academic, an independent statistician
Any quotes published will be anonymous. and a Patient and Public Involvement (PPI) representa-
tive. The DMEC will consist of an independent chair, an
Fidelity analysis independent statistician, and another independent mem-
The fidelity evaluation will examine the extent to which ber experienced in research with children and families.
the components of the intervention (Social Stories™) The TSC and DMEC will meet approximately every 6
were delivered as planned, and the accommodations re- months from the start of the trial. The TMG will com-
quired by schools to ensure this. Interventionists’ adher- prise co-applicants, members of the trial team (including
ence to core components will be assessed via researcher the data manager), PPI representatives, and the trial
completed fidelity checklists of each Social Story™ after managers. Co-applicants and trial team members will be
initial writing and at 6 weeks. invited as required depending on their roles.

Economic analysis Adverse event reporting

The economic analysis will be conducted from an NHS Possible harm as a result of the study will be monitored
and Personal Social (PSS) perspective, taking the form of according to YTU SOPs. Any Adverse Events (AEs) re-
a within-trial cost-effectiveness analysis determining the ported by individuals participating in the study will be
incremental cost per unit of outcome effectiveness meas- recorded using a bespoke Adverse Events Recording
ure for Social Stories™ compared with care as usual in Form and assessed for seriousness. AEs will be recorded
children with autism. Health outcomes will be measured as a Serious Adverse Event (SAE) if it results in death, is
in terms of quality-adjusted life-years (QALYs) using the life threatening, prolongs or requires hospitalisation, or
Wright et al. BMC Psychology (2020) 8:60 Page 8 of 10

results in disability or incapacity. Any AEs relating to Study limitations

study participation and all SAEs will be reported to the Due to the nature of the intervention it is not possible
CI. SAEs related to the study will be reported to the for participants to be blinded to study allocation, how-
study Sponsor, DMEC and TSC. ever the trial research assistants well as the trial statisti-
The DMEC will review data throughout the trial for cian remain blinded to help mitigate any potential
safety. If there is evidence of harm due to the interven- impacts. Further this study focusses solely on the use of
tion or measures used, the DMEC will advise the TSC Social Stories™ in education based settings, dependent
with a possible recommendation to stop the trial. on study findings, further randomised research into the
use of Social Stories™ in the home may prove beneficial.

Protocol amendments Abbreviations

AEs: Adverse Events; ASC: Autism Spectrum Conditions; ASCEND: Autism
Prior to submission for ethical approval, protocol amend- Spectrum Conditions – Enhancing Nurture and Development;
ments will be approved by the CI, substantial amendments ASSSIST2: Autism Spectrum Social Stories In Schools Trial 2; CACE: Complier
will be approved by the CI, Sponsor and TMG. Amend- Average Causal Effect; CI: Chief Investigator; CONSORT: Consolidated
Standards of Reporting Trials; CRFs: Case Report Forms; DMEC: Data
ment history will be tracked by adopting version control Monitoring and Ethics Committee; EOI: Expression of Interest; HRA: Health
and by the use of an amendment log. Research Authority; ISRCTN: International Standardised Randomised
Controlled Trial Number; ITT: Intention to treat; NICE: The National Institute
for Health and Care Excellence; NIHR: National Institute of Health; PPI: Patient
and Public Involvement; PSS: Personal Social; QALYs: Quality Adjusted Life
Dissemination
Years; RCADS: Revised Children Anxiety and Depression Scale;
Results will be published in mainstream and specialist RCT(s): Randomised Controlled Trial(s); SAEs: Serious Adverse Events;
science journals. Study findings will be presented at rele- SEN: Special Educational Needs; SENCO: Special Educational Needs
Coordinator; SOPs: Standard Operating Procedures; SRS-2: Social
vant research conferences, symposia and seminars. In
Responsiveness Scale Second Edition; TA: Teaching Assistant; TMG: Trial
addition, the National Autistic Society and members of Management Group; TSC: Trial Steering Committee; YTU: York Trials Unit
service user groups such as ASCEND will be consulted
Acknowledgments
in the development of methods for dissemination that
We would like to thank the families, teachers and researchers involved in the
will be effective in reaching families of children with feasibility research prior to this who have helped to shape this study. We
ASC. We will also produce a short summary of results would also like to thank Trial managers Jane Blackwell, Kerry Bell and Shirley
Paul for support in developing the protocol from the feasibility study and
that can be distributed to trial participants as well as
the trial management group including Anne McKelvey, Ann McLaren and
relevant interest and patient groups. We will publish Simon Gilbody. Holly Judge from the National Autistic Society has given
findings on relevant websites such as the National Autis- invaluable advice. Thanks also to Louise Meehan.
tic Society, university and child mental health websites.
Authors’ contributions
We aim to ensure coverage of our findings in the wider BW is the study CI and chair of the TMG. BW, DM1, JW, DV, VA, RH2, SA, DM2
media by issuing a press release. and CH were responsible for initial conception and design of the study and
the draft of the protocol. CT, RH1, LM, EK and NM were responsible for
Towards the end of the trial, our PPI representatives
substantial alteration to the protocol and design of the study and the
will organise a meeting with stakeholders including par- acquisition of data. SP, SA and HW were responsible for the design and
ents and professionals working with young people who analysis of the health economic component of the trial. LM and CH were
responsible for the design of the statistical analysis sections of the trial. All
have ASC to discuss the dissemination of the study find-
authors made substantial contribution to the drafting, critical revision and
ings. We will hold a research dissemination event for na- final approval of the document.
tional and local clinicians and policy makers. Depending
Funding
on findings, we will make suggestions to NICE about
This paper is independent research funded by the National Institute for
treatment evidence. Health Research (NIHR Health Technology Assessment, 16/111/91 – Autism
Spectrum Social Stories In Schools Trial 2 (ASSSIST2): A randomised
controlled trial and economic evaluation of a Social Stories intervention to
Discussion address the social emotional health of children with ASD in primary schools).
The views expressed in this publication are those of the authors and not
This study aims to examine the clinical and cost effect- necessarily those of the NHS, the National Institute for Health Research or
iveness of Social Stories™ intervention when used in the Department of Health and Social Care. The funder allows researchers full
education settings with primary school children. This independence but makes certain requirements to ensure that there is good
research governance. This includes requiring the research team to have an
large scale trial builds upon the initial feasibility work independent Trial Steering Group, and independent Data Monitoring Ethics
conducted [32], and will enhance a growing body of Committee and to report quarterly on milestone progress. They also require
promising literature [15, 18–31] by comparing the funded studies to follow the Good Clinical Practice guidelines laid out by the
International Committee for Harmonisation (ICH- GCP).
outcomes of children receiving care as usual only and
children receiving Social Stories™ in addition to care as Availability of data and materials
usual in a fully powered RCT. Results from this study Anonymised participant data from the ASSSIST2 trial will be made available
via the sponsor. Those wishing to access this data must apply to the sponsor
will help to inform school based interventions for and show that they have sound scientific reasons for requesting access to
children with a diagnosis of ASC. the data as well as having acceptable research methods. Other documents
Wright et al. BMC Psychology (2020) 8:60 Page 9 of 10

that will be made available include the study’s protocol, statistical analysis 9. White SW, Kreiser NL, Pugliese C, Scarpa A. Social anxiety mediates the
plan, health economics plan as well as the case report forms used effect of autism spectrum disorder characteristics on hostility in young
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Ethical approval for the study was granted by the University of York’s disruptive primary-school children. Br J Psychiatry. 2010;196(4):282–9.
Department of Health Sciences Research Governance Committee on 3rd https://doi.org/10.1192/bjp.bp.108.061341.
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approval was granted on 23rd July by Health and Care Research Wales support of children and young people on the autism spectrum. London:
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written consent on behalf of their participating child/children and written 13. Travis L, Sigman M, Ruskin E. Links between social understanding and social
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Not applicable. 116–34. https://doi.org/10.1097/00011363-200304000-00005.
15. Scattone D, Tingstrom D, Wilczynski S. Increasing appropriate social
Competing interests interactions of children with Autism Spectrum Disorders using Social
A copy of the Social Stories™ manual (co-developed by Barry Wright – study Stories™. Focus Autism Other Dev Disabl. 2006;21(4):211–22. https://doi.org/
CI) is provided to all participating schools and is used during the study 10.1177/10883576060210040201.
training sessions. This was developed during the feasibility study. All royalties 16. Gray C. The new social story book. Texas: Future Horizons; 2010.
earned by Barry Wright have to date been given to charity as part of a 17. National Research Council. Educating Children with Autism. Washington,
written agreement not to profit from this work. DC: The National Academies Press; 2001.
18. Ivey M, Heflin L, Alberto P. The use of Social Stories™ to promote
Author details independent behaviors in novel events for children with PDD-NOS. Focus
1
Child Oriented Mental Health Intervention Centre, Leeds and York Autism Other Dev Disabl. 2004;19(3):164–76. https://doi.org/10.1177/
Partnership NHS Foundation Trust, York, UK. 2Hull York Medical School, 10883576040190030401.
University of York, York, UK. 3COMIC, IT Centre, Innovation Way, Heslington, 19. Crozier S, Tincani M. Effects of Social Stories™ on prosocial behaviour of
York YO10 5NP, UK. 4York Trials Unit, Department of Health Sciences, preschool children with Autism Spectrum Disorders. J Autism Dev Disord.
University of York, York, UK. 5Centre for Reviews and Dissemination, 2007;37(9):1803–14. https://doi.org/10.1007/s10803-006-0315-7.
University of York, York, UK. 6Department of Health Sciences, University of 20. Delano M, Snell M. The effects of Social Stories™ on the social engagement
York, York, UK. 7Department of Epidemiology and Biostatistics, Schulich of children with autism. J Posit Behav Interv. 2006;8(1):29–42. https://doi.
School of Medicine, Western University, London, Ontario, Canada. org/10.1177/10983007060080010501.
21. Chan J, O'Reilly M. A Social Stories™ intervention package for students with
Received: 8 May 2020 Accepted: 5 June 2020 autism in inclusive classroom settings. J Appl Behav Anal. 2008;41(3):405–9.
https://doi.org/10.1901/jaba.2008.41-405.
22. Norris C, Dattilo J. Evaluating effects of a Social Story™ intervention on a
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