NCT05931094

Brief Summary

The study aims to determine the effects augmented reality game-based training on social communication 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

July 26, 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

AutismAugmented RealitySocial communication

Outcome Measures

Primary Outcomes (1)

  • Social Responsiveness Scale

    The Social Responsiveness Scale, Second Edition (SRS-2) measures social ability of children to adults. It is used primarily with individuals on the autism spectrum, family members of individuals on the autism spectrum, and others who have social impairments.

    After 8 weeks

Study Arms (2)

AR group

EXPERIMENTAL

Augmented Reality based games

Other: Augmented Reality based games

Traditional therapy group

ACTIVE COMPARATOR

Traditional therapy

Other: Traditional therapy

Interventions

Games of Wonder Tree Augmented Reality

AR group

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

Traditional therapy group

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

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
  • Liu R, Salisbury JP, Vahabzadeh A, Sahin NT. Feasibility of an Autism-Focused Augmented Reality Smartglasses System for Social Communication and Behavioral Coaching. Front Pediatr. 2017 Jun 26;5:145. doi: 10.3389/fped.2017.00145. eCollection 2017.

    PMID: 28695116BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderCommunication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

July 26, 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