NCT05962047

Brief Summary

The aim of the study is to determine the effects of usage of augmented reality for Restricted and repetitive behavior and executive function of children with autism spectrum disorder

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 26, 2023

Last Update Submit

June 12, 2024

Conditions

Keywords

Augmented RealityBehaviourExecutive function

Outcome Measures

Primary Outcomes (1)

  • Developmental Behaviour Checklist (DBC)

    The Developmental Behaviour Checklist (DBC) can be used for the assessment of behavioural and emotional problems of children and adolescents with development and intellectual disabilities. It is a questionnaire completed by parents or other primary carers, or teachers and reports problems over a six month period

    After 8 weeks

Secondary Outcomes (4)

  • Repetitive Behaviors Scale-Revised (RBS-R)

    After 8 weeks

  • The flexibility Scale

    After 8 weeks

  • Digital span memory test

    After 8 weeks

  • The Stroop test

    After 8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Augmented Reality games

Other: Games of WonderTree Augmented Reality

Group 2

ACTIVE COMPARATOR

Traditional therapy

Other: Traditional therapy

Interventions

Participants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree

Group 1

Traditional therapy based on play activities utilizing blocks, colors, Velcro-based toys.

Group 2

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.

You may not qualify if:

  • Sensory issues and patients on medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Development Center - Riphah International University

Islamabad, AL, 44000, Pakistan

Location

Related Publications (2)

  • Berenguer C, Baixauli I, Gomez S, Andres MEP, De Stasio S. Exploring the Impact of Augmented Reality in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 24;17(17):6143. doi: 10.3390/ijerph17176143.

    PMID: 32847074BACKGROUND
  • Dechsling A, Orm S, Kalandadze T, Sutterlin S, Oien RA, Shic F, Nordahl-Hansen A. Virtual and Augmented Reality in Social Skills Interventions for Individuals with Autism Spectrum Disorder: A Scoping Review. J Autism Dev Disord. 2022 Nov;52(11):4692-4707. doi: 10.1007/s10803-021-05338-5. Epub 2021 Nov 16.

    PMID: 34783991BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderBehavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcome assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 27, 2023

Study Start

July 25, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations