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Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Augmented Reality based games

Traditional therapy

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Augmented Reality, Social communication

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following. Exclusion Criteria: Sensory issues and patients on medication.

Sites / Locations

Child Development CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AR group

Traditional therapy group

Arm Description

Augmented Reality based games

Traditional therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05931094

First Posted

June 26, 2023

Last Updated

July 31, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05931094

Brief Title

Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder

Official Title

Effects of Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study aims to determine the effects augmented reality game-based training on social communication of children with autism spectrum disorder.

Detailed Description

Augmented Reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. Today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. Current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. The aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Autism, Augmented Reality, Social communication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AR group

Arm Type

Experimental

Arm Description

Augmented Reality based games

Arm Title

Traditional therapy group

Arm Type

Active Comparator

Arm Description

Traditional therapy

Intervention Type

Other

Intervention Name(s)

Augmented Reality based games

Intervention Description

Games of Wonder Tree Augmented Reality

Intervention Type

Other

Intervention Name(s)

Traditional therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Social Responsiveness Scale

Description

Time Frame

After 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suman Sheraz, PhD*

Phone

03335646361

suman.sheraz@riphah.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suman Sheraz, PhD*

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Child Development Center

City

Islamabad

State/Province

ZIP/Postal Code

44000

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suman Sheraz, PhD*

Phone

03335646361

suman.sheraz@riphah.edu.pk

First Name & Middle Initial & Last Name & Degree

Irum Nawaz, PhD*

irum.nawaz@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32847074

Citation

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.

Results Reference

background

PubMed Identifier

28695116

Citation

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.

Results Reference

background

Learn more about this trial

Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder

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