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

NCT04980677 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-27

No results posted yet for this study

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

Interventions

DEVICE

Tangiball

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).

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • Brighton & Sussex Medical School

    collaborator OTHER
  • Nottingham Trent University

    collaborator OTHER
  • University of Cambridge

    collaborator OTHER
  • Council for Disabled Children

    collaborator UNKNOWN
  • Autistica

    collaborator UNKNOWN
  • Sussex Community NHS Foundation Trust

    lead OTHER

Principal Investigators

  • William Farr, Dr · Sussex Community NHS Foundation Trust (SCFT), Haywards Heath Health Centre, Haywards Heath

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-03-30
Completion
2023-12-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980677 on ClinicalTrials.gov