Condition category
Mental and Behavioural Disorders
Date applied
27/01/2020
Date assigned
17/02/2020
Last edited
09/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Autistic Spectrum Disorders (ASD) are where a child's brain develops differently, leading to difficulties with social communication and interaction. ASD describes a range of severity, so that some people with ASD do not speak and find unfamiliar situations distressing, while others are able to work and function in society in a more typical way. ASD affect at least 1 in 100 of the population. It is recommended in the UK that diagnosis of ASD requires a mixed team of healthcare and education professionals. Information comes from many settings, including home and school, where evidence of autistic behaviours and/or patterns of thinking can be observed. There are tools available to guide observation of children, such as the Autism Diagnostic Observation Schedule (ADOS), but these tools can take a long time to complete. Research in the UK suggests it takes 13 hours of professional time to complete an assessment. This costs around £800 per child. Most teams use two stages. This includes an initial screening clinic to determine the need for the full multidisciplinary diagnostic assessment. Diagnostic services are under pressure to meet the growing demand. Waiting times can be between 6 months to 2 years to complete an assessment.
This study aims to investigate whether a game played on a tablet can incorporate tests used to detect signs of possible ASD in children. This could be a quick and fun way to identify children who could benefit from more detailed screening for ASD.

Who can participate?
Children aged 5-11 years who have either already been diagnosed with autism or who are developing typically and have not been in contact with a child development team .

What does the study involve?
The app is a pirate adventure game using Lego characters. It is played on a tablet. The children with autism will play the game while at the child development clinic. Typically developing children will play the game at school.

What are the possible benefits and risks of participating?
There are no potential benefits to playing the app, which takes around 10 minutes. The children will be told before they start that if they don't like playing the game, they should tell their parent or teacher. They can stop playing and nobody will be cross with them.

Where is the study run from?
Sussex Community NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2015 to September 2020

Who is funding the study?
British Medical Association Helen Lawson Fund (UK)

Who is the main contact?
Dr William Farr, will.farr@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr William Farr

ORCID ID

http://orcid.org/0000-0003-3644-5311

Contact details

Haywards Heath Health Centre
Heath Rd
Haywards Heath
RH16 3BB
United Kingdom
+44 (0)1444 475804
will.farr@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 35758, IRAS 217234

Study information

Scientific title

Establishing accuracy parameters of a child social communication assessment tool

Acronym

Study hypothesis

Autistic Spectrum Disorders (ASD) affect at least 1.1% of the population (CDC, 2014). NICE recommends that diagnosis requires a multidisciplinary team assessment, obtaining information from various settings including home and school, as well as testing for evidence of autistic behaviours and/or patterns of thinking (NICE, 2011). A number of tools have been developed to aid this process including observational tools such as the Autism Diagnostic Observation Schedule (ADOS). This is a lengthy process, our own study of practice in UK suggesting this takes around 13 hours of professional time to complete, costing around £800 per child (Galliver et al., in submission). Most teams (10 of 12) employed a two-stage process including an initial screening clinic determining the need for the full multidisciplinary diagnostic assessment. Diagnostic services are reporting increasing pressure to meet the growing level of demand, frequently resulting in waiting times of between 6 months and 2 years to complete an assessment (Autism Achieve Alliance, 2014).
This study aims to pilot a new digital tool, developed by the research team, which incorporates a number of psychometric tests used in diagnostic assessment. It is in the format of a pirate adventure game, that can be used at the initial assessment alongside history taking, screening questionnaires (e.g. SCQ), and information collected from educational settings. The assessment takes 10 minutes to complete and initial clinical experience suggests it provides useful additional information about the child.
This study will pilot the use of the tool in children attending an initial assessment clinic and in typically developing children attending a local primary school.

Ethics approval

Approved 30/10/2017, London - Hampstead Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester M1 3DZ; +44 (0)2071048127; nrescommittee.london-hampstead@nhs.net), ref: 16/LO/2138

Study design

Non-randomised; Interventional; Design type: Screening, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

See additional files.

Condition

Diagnosis of autistic spectrum disorders (ASD) in children

Intervention

Part 1: Observational study of use in clinic
Parents, and their children who are formally diagnosed with autism spectrum disorder, will be asked if they are willing to take part in the study with information leaflets sent out in advance. If they answer yes, then the research team will play Pirates with the child. This takes about 10 min to complete. In playing Pirates, the child will be asked a series of questions, presented in the game, exploring the child’s ability to recognise facial expressions, think what someone else is thinking, recognise sarcasm and the use of a lie and to understand idiom.

The child’s answers will be recorded on a scoresheet whilst an observation schedule will be used to record any unusual behaviours, and comments made by the child whilst playing the game. This will be performed on a single occasion as part of the clinic visit.

Parents will also be asked to complete the Social Communication Questionnaire (SCQ) if it was not completed as part of the diagnostic assessment. This is a validated screening tool containing 40 tickbox questions exploring the presence of possible autistic symptoms as reported by the parents. Scores of 15/40 or more indicate the need for formal diagnostic assessment and a score of 22 or more indicates likely ASD (Chandler et al, 2007). Parents already complete the SCQ as part of routine local clinical practice. Parents of those children who had the SCQ completed as part of the diagnostic assessment will be asked within consent to seek permission to access patient notes to obtain results of SCQ, and other formal clinical assessment e.g. ADOS, ADI.

The results of Pirates will be compared with the SCQ score and clinical diagnosis, which is based on formal history from parents e.g. ADI, formal observation of the child in clinic (ADOS), and observation of the child in-school.

Part 2: Testing use in typically developing children (controls) in local mainstream school
Children of primary school age (4-11) attending a local primary school will be assessed in the school setting by the research team. A study pack comprising information sheets (child and parent), consent form, child assent form, and a short parental questionnaire (assessing whether their child has any recognised developmental, communication or learning difficulties) will be sent home with the child. The game will be played in the same way as described above for the 'clinic group', but in the child's school, in sight of their classroom and teacher. Again this will be done on a single occasion, taking about 10 min to complete.

In order to avoid causing upset, or concerns about disability discrimination, children with special needs will be free to take part, and indeed it will be interesting to see how they perform, but their results will not be included as part of the 'typically developing' group. Results will again be recorded using the Pirates scoresheet and observation schedule. Whilst this is not a formal case-control study, we have included the typically developing children to act effectively as a control group, enabling us to determine whether children with no evidence of social communication difficulties perform differently to those where there are concerns.


Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Number of incorrect responses to questions recorded in the app. These data will be used to calculate sensitivity and specificity of the game in detecting possible autism.
2. Characteristics of ASD in children attending the clinic who have been diagnosed with an ASD assessed using the Social Communication Questionnaire (SCQ)

Secondary outcome measures

Behaviour and comments made by children while paying Pirates recorded on an observation schedule

Overall trial start date

01/04/2015

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Part 1:
1. Child of primary school age (i.e. 4-11 years)
2. Confirmed diagnosis of ASD following full multidisciplinary diagnostic assessment by a CDC

Part 2:
3. Child of primary school age (i.e. 4-11 years)
4. No concerns about the child’s social communication, and/or possible ASD. Children with these difficulties may take part in the study but results will not be included within 'typically developing' group analysis.
5. No developmental diagnoses such as learning difficulties, ADHD or Developmental Coordination Disorder. Children with these difficulties may take part in study but results will not be included within 'typically developing' group analysis.

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 124; UK Sample Size: 124

Total final enrolment

110

Participant exclusion criteria

Part 1:
1. No concerns about social communication or diagnosis of autistic spectrum disorder
2. Not under care of a CDC.
3. Children who speak English as a second language
4. Non-verbal
5. Severe learning difficulties

Part 2:
6. Children who speak English as a second language
7. Non-verbal
8. Severe learning difficulties

Recruitment start date

01/06/2018

Recruitment end date

05/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sussex Community NHS Foundation Trust
Brighton General Hospital Elm Grove
Brighton
BN2 3EW
United Kingdom

Sponsor information

Organisation

Sussex Community NHS Foundation Trust

Sponsor details

Research and Innovation Department
Bramber Building
Brighton General Hospital
Elm Grove
Brighton
BN2 3EW
United Kingdom
+44 (0)1273696011
helenvaughan@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

British Medical Association

Alternative name(s)

BMA

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication

Intention to publish date

30/09/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

09/09/2020: The following changes have been made: 1. The final enrolment number has been added. 2. The 'suspended' recruitment status has been removed. 23/04/2020: Due to current public health guidance, recruitment for this study has been paused. 17/02/2020: The participant information sheets have been uploaded. 30/01/2020: Trial's existence confirmed by the National Institute of Health Research (NIHR).