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Early Assessment of Autism Through Smart Tablet Gameplay

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ClinicalTrials.gov Identifier: NCT03438994
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
Harimata
University of Glasgow
University of Aberdeen
Göteborg University
Information provided by (Responsible Party):
Jonathan Delafield-Butt, University of Strathclyde

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other Neurodevelopmental Disorder Diagnostic Test: Play.Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will follow the "Standard for Reporting Diagnostic accuracy studies" (STARD) guidelines
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Toward Early Autism Assessment: A Prospective Diagnostic Accuracy Study
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Participants diagnosed with ASD Diagnostic Test: Play.Care
iPad based game to assess movement as the player interacts with the screen

Experimental: Participants diagnosed with OND Diagnostic Test: Play.Care
iPad based game to assess movement as the player interacts with the screen

Active Comparator: Typically developing participants Diagnostic Test: Play.Care
iPad based game to assess movement as the player interacts with the screen




Primary Outcome Measures :
  1. Diagnostic accuracy of Play.Care to detect ASD [ Time Frame: Single data collection time point of 15 minutes for each subject. ]
    sensitivity and specificity of Play.Care to detect ASD


Secondary Outcome Measures :
  1. Ability of Play.Care to distinguish ASD from OND [ Time Frame: Single data collection time point of 15 minutes for each subject. ]
    sensitivity and specificity of Play.Care to distinguish ASD from OND



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Inclusion Criteria:

    1. All participants:

      • Aged 30 months - 5 years inclusive
    2. 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)
    3. 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
  2. Exclusion Criteria:

    1. Typically developing participants:

      • Diagnosis or suspicion of
      • Neuropathology
      • Psychopathology
      • Sensory or motor disorder including mild tremors
    2. ASD participants:

      • Uncorrected sensory (visual, hearing) impairments
      • Presence of any motor impairments or behavioural impairment that may obstruct testing
    3. OND participants:

      • Sub-clinical or secondary expressions of ASD
      • Uncorrected hearing or vision impairments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438994


Contacts
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Contact: Lindsay Millar, PhD 0141 548 2228 l.clarke@strath.ac.uk
Contact: Philip Rowe, PhD philip.rowe@strath.ac.uk

Locations
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Sweden
Gillberg Neuropsychiatry Centre Recruiting
Gothenburg, Sweden, 411 19
Contact: Ingrid Vinsa    +46 (0) 31 342 59 70    ingrid.vinsa@gnc.gu.se   
Contact: Bibbi Hagberg       bibbi.hagberg@gu.se   
United Kingdom
University of Strathclyde Enrolling by invitation
Glasgow, United Kingdom, G
Sponsors and Collaborators
University of Strathclyde
Harimata
University of Glasgow
University of Aberdeen
Göteborg University
Investigators
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Principal Investigator: Jonathan Delafield-Butt, PhD jonathan.delafield-butt@strath.ac.uk

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Responsible Party: Jonathan Delafield-Butt, Principal Investigator, Director Laboratory for Innovation in Autism, University of Strathclyde
ClinicalTrials.gov Identifier: NCT03438994     History of Changes
Other Study ID Numbers: UEC17/49
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Delafield-Butt, University of Strathclyde:
autism
movement
tablet
gameplay

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Neurodevelopmental Disorders
Pathologic Processes
Child Development Disorders, Pervasive
Mental Disorders