A Smart Toy for Motor Function and Early Assessment of Children With Possible Autism

NCT04980677 | Unknown DMC

• 1 other identifier: SCFT v1.0_Tangiball_29/04/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Keywords

Autism; "Internet of Things"; Digital toy; Clinical acceptability; Prototype

Outcome Measures

Primary Outcomes (2)

• Accelerometer outputs

  Data recording of movement on X, Y, Z axis (placement of jack, duration of placement within tangiball)

  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.

  11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)

Secondary Outcomes (1)

• "Hands-On" assessment tool

  11 months or until recruitment target for intervention phase is reached (including 10 months recruitment phase)

Study Arms (1)

Children

OTHER

Tangiball (Autism, Neurotypical group) - 20 minute play sessions with digital toy

Device: Tangiball

Interventions

Tangiball DEVICE

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).

Also known as: Smart Toy for Early ASD Assessment

Children

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sussex Community NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Brighton & Sussex Medical School: collaborator
• Nottingham Trent University: collaborator
• University of Cambridge: collaborator
• Council for Disabled Children: collaborator
• Autistica: collaborator

Study Sites (1)

Sussex Community NHS Foundation Trust

Brighton, BN2 3EW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders

Study Officials

• William Farr, Dr

  Sussex Community NHS Foundation Trust (SCFT), Haywards Heath Health Centre, Haywards Heath

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Farr, Dr

CONTACT

01444 475804; will.farr@nhs.net

Donna Cowan

CONTACT

01444 696011; donna.cowan@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 28, 2021
• Study Start: February 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)