Autism Spectrum DisorderNCT03438994
Early Assessment of Autism Through Smart Tablet Gameplay
A study testing Play.Care in people with Autism Spectrum Disorder and Other Neurodevelopmental Disorder, run by University of Strathclyde at 2 sites in 2 countries.
Trial summary
The primary aim of this study is to compare the diagnostic accuracy of an iPad application (Play.Care assessment) with the current clinical "gold standard" diagnosis for diagnosis of Autism Spectrum Disorder (ASD) in children. Read more about this study
- Who is it for?
- Ages 30 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Other Neurodevelopmental Disorder
- What is being tested?
- Play.Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 779 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jan 2018to 30 Jul 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
- Inclusion Criteria:
- All participants:
- Aged 30 months - 5 years inclusive
- ASD Participants:
- Diagnosis of autism spectrum disorder on the basis of DSM-V criteria or equivalent ICD-10 framework (F84): childhood autism (F84.0), atypical autism (F84.1), and Asperger's syndrome (F84.5)
- OND participants:
- Other childhood developmental disorders including, but not limited to,
- Attention Deficit Hyperactivity Disorder,
- Developmental Coordination Disorder,
- Intellectual disability,
- Non- verbal disability and
- Communication Disability.
- Sensory and motor impairments will be included
- Exclusion Criteria:
- Typically developing participants:
- Diagnosis or suspicion of
- Neuropathology
- Psychopathology
- Sensory or motor disorder including mild tremors
- ASD participants:
- Uncorrected sensory (visual, hearing) impairments
- Presence of any motor impairments or behavioural impairment that may obstruct testing
- OND participants:
- Sub-clinical or secondary expressions of ASD
- Uncorrected hearing or vision impairments
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Toward Early Autism Assessment: A Prospective Diagnostic Accuracy Study
The primary aim of this study is to compare the diagnostic accuracy of an iPad application (Play.Care assessment) with the current clinical "gold standard" diagnosis for diagnosis of Autism Spectrum Disorder (ASD) in children. Recent evidence has suggested that movement abnormalities are one of the early markers of ASD. However, current clinical diagnostic assessments fail to take this into account. Further, the current "gold standard" clinical tests take a number of hours to administer, require extensive clinical training and are subject to a certain level of subjectivity. Alternatively, by assessing a child's interaction with an iPad screen as they play, an objective measurement of movement can be obtained, which can aid in the diagnostic process.
This study aims to recruit a total of 760 children (Typically Developing (TD), Other Neurodevelopmental Disorders (OND) and ASD groups) to assess the diagnostic accuracy of tablet game play in ASD. Children who have been diagnosed with ASD will perform the Play.Care assessment to assess if the tablet result matches their clinical diagnosis. Results from the clinical assessment and Play.Care assessment will then be compared to assess the sensitivity (the proportion of participants with ASD who test positive for ASD as a result of the Play.Care assessment) and specificity (the proportion of participants without ASD who test negatively for ASD as a result of the Play.Care assessment assessment) of the Play.Care assessment.
Read the detailed description
Autism Spectrum Disorder (ASD) has, historically, been described as primarily a socio-cognitive disorder. While it has been noted that individuals with ASD may exhibit movement abnormalities such as altered gait or increased clumsiness, recent evidence has suggested the possible presence of an underlying motor disruption, common to individuals with ASD. By using smart tablet technology with built in 3 dimensional gyroscopes and accelerometers, we are now able to assess the movement of children with ASD as they interact with tablet screens during game play. It is proposed that this could be an enlightening avenue for assessment or even diagnosis of ASD.
The primary aim of this study is to clinically validate the ability of a new iPad game (called Play.Care) for diagnosis of ASD in children aged 30 months to 5 years (inclusive).
Three groups of participants will be recruited: children with a clinical diagnosis of ASD, children with a clinical diagnosis of an Other Neurodevelopmental Disorder (OND) and children developing typically (TD). A total of 760 children will be recruited between two cities, Glasgow, Scotland, United Kingdom and Gothenburg, Sweden. Gothenburgh will recruit 180 participants diagnosed with ASD, 60 participants diagnosed with OND and 100 typically developing participants. Glasgow will recruit 100 participants diagnosed with ASD, 140 participants diagnosed with OND and 180 participants developing typically.
Children developing typically will be recruited from local private nurseries. Children diagnosed with ASD or OND will be recruited from clinical diagnostic centres and specialist or inclusive schools.
Parents of children will be given a Participant Information Sheet and sign a Consent Form under protocol approved by health services (Glasgow and Gothenburg) and University ethics committees.
If the family is happy to participate, the child can either complete the Play.Care game in the clinic, during preschool hours in the preschool, or, if it is more suitable for the family, the researcher can come to their home. In either case, at the start of the data collection appointment, the parents must sign the consent form. Further information about the child's emotional state on the day of data collection will be recorded (e.g. mood, arousal, cooperativity). If the parents consented to their child being video recorded, a video camera will be setup prior to game play. This will give more information about the overall movement of the child as they play. The iPad will then be introduced to the child. Two games will be played. The first game is called 'Sharing' and requires the child to tap a piece of food to split it into 4 pieces and share it amongst game characters. The second game is called 'Creativity' and requires the child to choose an animal or object to trace and colour in. Each game has a two minute training phase followed by a five minute assessment phase. While the child is playing the games, or at an appropriate time, parents will be asked to complete 3 questionnaires about their child's everyday behaviour. These are standard assessments for children with ASD or OND and will help us understand how the information from Play.Care relates to everyday behaviour. These are the Strengths and Difficulties Questionnaire (SDQ), the Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations Questionnaire (ESSENCE-Q) and the Adaptive Behaviour Assessment Scale (ABAS). In some cases, information gathered during normal clinical assessment will also be gathered, namely but not exclusively the Vinelands Adaptive Behaviour Scale (VABS) and the Wechsler Preschool \& Primary Scale of Intelligence (WPPSI). Once the questionnaires and the Play.Care assessment are complete, no further participation is required.
- Being tested
- Play.Care
- Keywords
- autism, movement, tablet, gameplay
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play.CareDiagnostic test
iPad based game to assess movement as the player interacts with the screen
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with ASD | Active comparator | Not described Receives: Diagnostic Test: Play.Care |
| Participants diagnosed with OND | Experimental | Not described Receives: Diagnostic Test: Play.Care |
| Typically developing participants | Active comparator | Not described Receives: Diagnostic Test: Play.Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Play.Care to detect ASD
sensitivity and specificity of Play.Care to detect ASD
Measured: Single data collection time point of 15 minutes for each subject.
Secondary outcomes (1)
Ability of Play.Care to distinguish ASD from OND
sensitivity and specificity of Play.Care to distinguish ASD from OND
Measured: Single data collection time point of 15 minutes for each subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start10 Jan 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will follow the "Standard for Reporting Diagnostic accuracy studies" (STARD) guidelines
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Collaborators
- Harimata, University of Glasgow, University of Aberdeen, Göteborg University
- Responsible party
- Principal investigator, Jonathan Delafield-Butt, University of Strathclyde
- Investigators
- Jonathan Delafield-Butt, PhD, Principal investigator, jonathan.delafield-butt@strath.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438994
- Sponsor's protocol ID
- UEC17/49
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Millar L, McConnachie A, Minnis H, Wilson P, Thompson L, Anzulewicz A, Sobota K, Rowe P, Gillberg C, Delafield-Butt J. Phase 3 diagnostic evaluation of a smart tablet serious game to identify autism in 760 children 3-5 years old in Sweden and the United Kingdom. BMJ Open. 2019 Jul 16;9(7):e026226. doi: 10.1136/bmjopen-2018-026226.
PubMed 31315858