Autism Spectrum DisorderTangiballNCT04980677
A Smart Toy for Motor Function and Early Assessment of Children With Possible Autism
A study testing Tangiball in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Sussex Community NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Autism diagnostic referrals across the UK have doubled within the last five years. Covid-19 has further delayed diagnostic pathways, while innovation has not kept pace in assisting clinical teams with low cost, fast, and unobtrusive pathways to shorten waiting times for families of children with possible Autism. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder, Neurodevelopmental Disorders
- What is being tested?
- Tangiball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Intervention phase:
- child aged 2-5 years and either:
- diagnosed with Autism
- is a neurotypical child with no prior contact with a Child Development Clinical Service for social communication problems
- Focus groups, interviews, surveys:
- either a parent of a child diagnosed with autism, or clinician who is involved in autism diagnosis
Who cannot join
- Intervention phase:
- neurotypical child has prior referral to Child Development Clinical Service Child
- child is outside of age range
- child not under the care of Child Development Clinical Service
- Focus groups, interviews, surveys:
- parent not of child with Autism, or a clinician not involved in autism diagnostic services
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sussex Community NHS Foundation Trust
Brighton, BN2 3EW
William Farr, Dr, 01444 475804., will.farr@nhs.net
William Farr, Dr
About this study
Official title: "Tangiball": Acceptability of a Smart Toy Tool for the Clinical Detection of Sensori-Motor Dysfunction in Children With Possible Autism Aged 2-5
Autism diagnostic referrals across the UK have doubled within the last five years. Covid-19 has further delayed diagnostic pathways, while innovation has not kept pace in assisting clinical teams with low cost, fast, and unobtrusive pathways to shorten waiting times for families of children with possible Autism. Sensor-based technology offers a potentially cheap, small-scale, and unobtrusive way of collecting data while children interact seamlessly with smart play objects and toys that allows a clear comparison with neuro-typical groups or children.The present exploratory group intervention (intervention, interview, focus group, and questionnaire) will map out and investigate clinical interaction through the use of "Tangiball"-a new low-cost smart toy that is highly reliable and sensitive-that has the potential to significantly reduce the timing of the diagnostic process in young children with possible Autism. The "Tangiball" records user speed and accuracy of movement, which aligns with variability between neuro-typical children and children with Autism, but is it an acceptable clinical tool for diagnostics and play?
Read the detailed description
Sensor-based technology offers a potentially cheap, small-scale, unobtrusive, and data rich capture environment. Harnessing data capture whilst children interact seamlessly with play objects and toys, will enable large-scale data insight into the active behaviour of children, allowing clear comparisons with neurotypical groups. Data comparison can be modelled on diagnostic manual descriptions, and would enhance pathology descriptions. Smart systems can provide diagnostic evidence that can be compiled for children with disabilities and be appropriately compared to neuro-typical baseline data. Borderline diagnosis and confusion can be avoided, as collected data can then be used in addition to observable report. This data elicits new information about the way children with Autism and associated developmental disorders interact with their environment on a micro-level. Children with Autism when using smart objects show slow movement, where deceleration during grasping reaching and placing activities takes longer than neurotypical peers, the amplitude of reach speed is at its peak higher than typical peers, maximum acceleration through space is slower, and the time taken to reach speed peak is higher such that speed and accuracy can account for 76% of all variance between children with Autism and typical peers. Children with Autism therefore experience qualitative differences in the way they navigate their own body and interact with objects within their own environment. Stereotyped or repetitive motor movements, hyper- or hypo-reactivity to sensory input, and unusual interests in sensory aspects of objects, remain central to Autism diagnosis. Atypical sensory and physical behaviour is estimated in 92% of children with ASD and 67% of children with SEND equating to one million affected school children. Diagnosis and clinical interaction of children with possible autism currently relies on the use of subjective observational inventories (SOIs) such as ADOS, whilst engaging children in unfamiliar surroundings, against the backdrop of dwindling resources. Autism assessment referrals across KSS have doubled within the last five years. Covid-19 has further delayed pathways. Innovation has not kept pace in assisting clinical teams with low cost, fast and unobtrusive pathways to shorten waiting times. As clinical interactions with younger children nearly always utilise toys to improve engagement, this Smart Toy solution enables automated data capture-otherwise lost-by embedding sensors (e.g. RIFD, IMU Bluetooth) in toys. Accurate data capture during object interaction has potential to significantly reduce assessment time-a recognised problem highlighted in the NHS Long term plan.
"Tangiball" is a new low-cost smart toy that is highly reliable and sensitive that has the potential to significantly reduce the timing of the diagnostic process in young children with possible Autism. The "Tangiball" records user speed and accuracy of movement, which aligns with variability between neuro-typical children and children with Autism. The present exploratory group intervention study (intervention, interview, focus group, and questionnaire) will map out and investigate clinical interaction through the use of sensors that can tell the investigators how children are interacting with objects, and how this diverges from neurotypical children. The project aims to establish the "Tangiball" as an acceptable tool for clinical staff, children, and parents during clinical interaction; that clinical interaction with a Smart Toy enables useful data to be gathered that can support the diagnostic process in young children. With few smart devices embedded into everyday clinical practice this project completes and trials an Internet of Medical Things Smart Toy for use in child development clinics, to capture child interaction with objects and assist in profiling. This can help determine appropriate pathways to care. Thirty children (n=15 with a formal diagnosis of Autism Spectrum Disorder, n=15 neurotypical children with no prior referral to a child development clinic), aged 2-5 years will be recruited over a period of 11 months via clinical teams and through schools. The intervention will run either in clinic or in children's homes. Children will play with the Smart Toy system during a 20 minute session. Children will be matched according to age, and score on the four-strand "Hands-On" assessment tool. Parents and children will complete a User Experience Questionnaire [UE-Q] which assesses user acceptability and experience of the Smart Toy. Sessions will be recorded using an SD card within the Smart Toy which records information on user speed and accuracy of placement of the detachable segments of the toy when placed into the main hub of the toy. Ten clinicians (comprising SALTs, Psychologists and Paediatricians) will be interviewed to explore themes around smart toy use and acceptability. Data produced will explore the acceptability and optimisation of triage using a novel, low-cost device that is highly reliable and sensitive, including physical and behaviour profiling to increase timely accurate identification of strengths and weaknesses in children in the early school-age, and pre-school population (2 to 5 years) where there is a current pressure on identification.
- Being tested
- Tangiball
- Keywords
- Autism, "Internet of Things", Digital toy, Clinical acceptability, Prototype
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TangiballDevice
Also called Smart Toy for Early ASD Assessment
To enable baseline scores comparison, children will be matched according to age and score on the four-strand "Hands-On" assessment tool which takes 30 minutes to complete. Children will then play with the Smart Toy during a 20 minute session. Sessions will be recorded using an SD card within the Smart Toy which captures information on user speed and accuracy of placement of the detachable segments of the toy when placed into the main hub of the toy, allowing comparison between neuro-typical children and children with Autism. The intervention will run either in clinic (preferred option) or in children's homes-and in this case will be sent to them via post with the Standard Operating Procedure which can then be employed when children are taking part in the intervention via online video link (not recorded).
| Study group | Role | What they receive |
|---|---|---|
| Children | Other | Tangiball (Autism, Neurotypical group) - 20 minute play sessions with digital toy Receives: Device: Tangiball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer outputs
Data recording of movement on X, Y, Z axis (placement of jack, duration of placement within tangiball)
Measured: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)
User Experience Questionnaire
Parents and children will complete a User Experience Questionnaire which assesses user acceptability and experience of the Smart Toy. This questionnaire asks a response to two binary choices on a 7-point likert scale e.g. "Annoying - Understandable" and so will give numerical response where the higher the score, the better the response.
Deploy and assess acceptability of the Smart Toy.
Measured: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)
Secondary outcomes (1)
"Hands-On" assessment tool
Baseline scores of children collected by means of "Hands-On" assessment will be compared to Accelerometer outputs.The "Hand-On" tool establishes scores across four dimensions in the 3-8 age group of obtaining objects, practical use of objects, repensetattional use of objects, and social use of objects. Each dimension is scored according to sub-categories on a scale of "Mastered" (score = 2), "Emerging" (score = 1) or "Not present" (score = 0). Each dimension is then calculated as a subtotal before a grand score out of 78 (also calculated as a percentage). The higher the score the better the child's interaction with objects across the four dimensions.
Measured: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Feb 2021
- Primary completion30 Mar 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sussex Community NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Brighton & Sussex Medical School, Nottingham Trent University, University of Cambridge, Council for Disabled Children, Autistica
- Responsible party
- Sponsor
- Investigators
- William Farr, Dr, Principal investigator, Sussex Community NHS Foundation Trust (SCFT), Haywards Heath Health Centre, Haywards Heath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980677
- Sponsor's protocol ID
- SCFT v1.0_Tangiball_29/04/2021
- Acronym
- Tangiball
- Status last verified
- Apr 2023
- First submitted
- 10 Jun 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Tangiball": Acceptability of a Smart Toy Tool for the Clinical Detection of Sensori-Motor Dysfunction in Children With Possible Autism Aged 2-5
- ClinicalTrials.gov ID
- NCT04980677
- Acronym / sponsor ID
- Tangiball / SCFT v1.0_Tangiball_29/04/2021
- Keywords
- Autism, "Internet of Things", Digital toy, Clinical acceptability, Prototype
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sussex Community NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Brighton & Sussex Medical School, Nottingham Trent University, University of Cambridge, Council for Disabled Children, Autistica
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism diagnostic referrals across the UK have doubled within the last five years. Covid-19 has further delayed diagnostic pathways, while innovation has not kept pace in assisting clinical teams with low cost, fast, and unobtrusive pathways to shorten waiting times for families of children with possible Autism. Sensor-based technology offers a potentially cheap, small-scale, and unobtrusive way of collecting data while children interact seamlessly with smart play objects and toys that allows a clear comparison with neuro-typical groups or children.The present exploratory group intervention (intervention, interview, focus group, and questionnaire) will map out and investigate clinical interaction through the use of "Tangiball"-a new low-cost smart toy that is highly reliable and sensitive-that has the potential to significantly reduce the timing of the diagnostic process in young children with possible Autism. The "Tangiball" records user speed and accuracy of movement, which aligns with variability between neuro-typical children and children with Autism, but is it an acceptable clinical tool for diagnostics and play?
Detailed description
Sensor-based technology offers a potentially cheap, small-scale, unobtrusive, and data rich capture environment. Harnessing data capture whilst children interact seamlessly with play objects and toys, will enable large-scale data insight into the active behaviour of children, allowing clear comparisons with neurotypical groups. Data comparison can be modelled on diagnostic manual descriptions, and would enhance pathology descriptions. Smart systems can provide diagnostic evidence that can be compiled for children with disabilities and be appropriately compared to neuro-typical baseline data. Borderline diagnosis and confusion can be avoided, as collected data can then be used in addition to observable report. This data elicits new information about the way children with Autism and associated developmental disorders interact with their environment on a micro-level. Children with Autism when using smart objects show slow movement, where deceleration during grasping reaching and placing activities takes longer than neurotypical peers, the amplitude of reach speed is at its peak higher than typical peers, maximum acceleration through space is slower, and the time taken to reach speed peak is higher such that speed and accuracy can account for 76% of all variance between children with Autism and typical peers. Children with Autism therefore experience qualitative differences in the way they navigate their own body and interact with objects within their own environment. Stereotyped or repetitive motor movements, hyper- or hypo-reactivity to sensory input, and unusual interests in sensory aspects of objects, remain central to Autism diagnosis. Atypical sensory and physical behaviour is estimated in 92% of children with ASD and 67% of children with SEND equating to one million affected school children. Diagnosis and clinical interaction of children with possible autism currently relies on the use of subjective observational inventories (SOIs) such as ADOS, whilst engaging children in unfamiliar surroundings, against the backdrop of dwindling resources. Autism assessment referrals across KSS have doubled within the last five years. Covid-19 has further delayed pathways. Innovation has not kept pace in assisting clinical teams with low cost, fast and unobtrusive pathways to shorten waiting times. As clinical interactions with younger children nearly always utilise toys to improve engagement, this Smart Toy solution enables automated data capture-otherwise lost-by embedding sensors (e.g. RIFD, IMU Bluetooth) in toys. Accurate data capture during object interaction has potential to significantly reduce assessment time-a recognised problem highlighted in the NHS Long term plan.
"Tangiball" is a new low-cost smart toy that is highly reliable and sensitive that has the potential to significantly reduce the timing of the diagnostic process in young children with possible Autism. The "Tangiball" records user speed and accuracy of movement, which aligns with variability between neuro-typical children and children with Autism. The present exploratory group intervention study (intervention, interview, focus group, and questionnaire) will map out and investigate clinical interaction through the use of sensors that can tell the investigators how children are interacting with objects, and how this diverges from neurotypical children. The project aims to establish the "Tangiball" as an acceptable tool for clinical staff, children, and parents during clinical interaction; that clinical interaction with a Smart Toy enables useful data to be gathered that can support the diagnostic process in young children. With few smart devices embedded into everyday clinical practice this project completes and trials an Internet of Medical Things Smart Toy for use in child development clinics, to capture child interaction with objects and assist in profiling. This can help determine appropriate pathways to care. Thirty children (n=15 with a formal diagnosis of Autism Spectrum Disorder, n=15 neurotypical children with no prior referral to a child development clinic), aged 2-5 years will be recruited over a period of 11 months via clinical teams and through schools. The intervention will run either in clinic or in children's homes. Children will play with the Smart Toy system during a 20 minute session. Children will be matched according to age, and score on the four-strand "Hands-On" assessment tool. Parents and children will complete a User Experience Questionnaire [UE-Q] which assesses user acceptability and experience of the Smart Toy. Sessions will be recorded using an SD card within the Smart Toy which records information on user speed and accuracy of placement of the detachable segments of the toy when placed into the main hub of the toy. Ten clinicians (comprising SALTs, Psychologists and Paediatricians) will be interviewed to explore themes around smart toy use and acceptability. Data produced will explore the acceptability and optimisation of triage using a novel, low-cost device that is highly reliable and sensitive, including physical and behaviour profiling to increase timely accurate identification of strengths and weaknesses in children in the early school-age, and pre-school population (2 to 5 years) where there is a current pressure on identification.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | Other | Device: TangiballTangiball (Autism, Neurotypical group) - 20 minute play sessions with digital toy |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Intervention phase:
- Focus groups, interviews, surveys:
- either a parent of a child diagnosed with autism, or clinician who is involved in autism diagnosis
Key exclusion criteria (6 listed)
- Intervention phase:
- Focus groups, interviews, surveys:
- parent not of child with Autism, or a clinician not involved in autism diagnostic services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TangiballAlso: Smart Toy for Early ASD AssessmentTo enable baseline scores comparison, children will be matched according to age and score on the four-strand "Hands-On" assessment tool which takes 30 minutes to complete. Children will then play with the Smart Toy during a 20 minute session. Sessions will be recorded using an SD card within the Smart Toy which captures information on user speed and accuracy of placement of the detachable segments of the toy when placed into the main hub of the toy, allowing comparison between neuro-typical children and children with Autism. The intervention will run either in clinic (preferred option) or in children's homes-and in this case will be sent to them via post with the Standard Operating Procedure which can then be employed when children are taking part in the intervention via online video link (not recorded). | Device | Children |
Primary outcome
Accelerometer outputs
Time frame: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)
Data recording of movement on X, Y, Z axis (placement of jack, duration of placement within tangiball)
User Experience Questionnaire
Time frame: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)
Parents and children will complete a User Experience Questionnaire which assesses user acceptability and experience of the Smart Toy. This questionnaire asks a response to two binary choices on a 7-point likert scale e.g. "Annoying - Understandable" and so will give numerical response where the higher the score, the better the response. Deploy and assess acceptability of the Smart Toy.
1 secondary outcome
"Hands-On" assessment tool
Time frame: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Farr, Dr principal investigator
Sussex Community NHS Foundation Trust (SCFT), Haywards Heath Health Centre, Haywards Heath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tangiball in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Sussex Community NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Farr, Dr (01444 475804, will.farr@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer outputs (time frame: 11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.