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Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Games of WonderTree Augmented Reality
Traditional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Augmented Reality, Behaviour, Executive function

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 Center - Riphah International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Augmented Reality games

Traditional therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Repetitive Behaviors Scale-Revised (RBS-R)
The RBS-R is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders.
The flexibility Scale
Cognitive flexibility is the ability to switch between different thoughts and actions. It is considered part of executive functions, which are the general mental functions that help us to coordinate thought and action. The tool has a four point ordinal likert scale scoring for each item. Higher scores (after reverse scoring) mean greater endorsement of problems / characteristics.
Digital span memory test
Digital span test will be used to determine working memory. It is a working memory test that is used in many cognitive and neuroscience research labs. Th patient is instructed to repeat the sequence of numbers shown during the test. To make it more interesting, gradually increase the Span, which starts out at 8, and change to Fast test speed. The Digit Span score is the length of the longest correctly repeated sequence
The Stroop test
The Stroop test also known as the color-word naming test, will be used for cognitive inhibition. It is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference. The basic Stroop scores (time taken in seconds for each of the three cards) will be entered. Subjects (S's) basic score on each card is the total time (in seconds) to utter the 100 names.

Full Information

First Posted
June 26, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05962047
Brief Title
Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder
Official Title
Use of Augmented Reality for Restricted and Repetitive Behavior and Executive Function 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 25, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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
Augmented Reality, Behaviour, Executive function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcome assessor)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Augmented Reality games
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Traditional therapy
Intervention Type
Other
Intervention Name(s)
Games of WonderTree Augmented Reality
Intervention Description
Participants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree
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
Developmental Behaviour Checklist (DBC)
Description
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
Time Frame
After 8 weeks
Secondary Outcome Measure Information:
Title
Repetitive Behaviors Scale-Revised (RBS-R)
Description
The RBS-R is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders.
Time Frame
After 8 weeks
Title
The flexibility Scale
Description
Cognitive flexibility is the ability to switch between different thoughts and actions. It is considered part of executive functions, which are the general mental functions that help us to coordinate thought and action. The tool has a four point ordinal likert scale scoring for each item. Higher scores (after reverse scoring) mean greater endorsement of problems / characteristics.
Time Frame
After 8 weeks
Title
Digital span memory test
Description
Digital span test will be used to determine working memory. It is a working memory test that is used in many cognitive and neuroscience research labs. Th patient is instructed to repeat the sequence of numbers shown during the test. To make it more interesting, gradually increase the Span, which starts out at 8, and change to Fast test speed. The Digit Span score is the length of the longest correctly repeated sequence
Time Frame
After 8 weeks
Title
The Stroop test
Description
The Stroop test also known as the color-word naming test, will be used for cognitive inhibition. It is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference. The basic Stroop scores (time taken in seconds for each of the three cards) will be entered. Subjects (S's) basic score on each card is the total time (in seconds) to utter the 100 names.
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
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suman Sheraz, PhD*
Phone
03335646361
Email
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 - Riphah International University
City
Islamabad
State/Province
AL
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PhD*
Phone
03335646361
Email
suman.sheraz@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Irum Nawaz, PhD*
Phone
03325382657

12. IPD Sharing Statement

Plan to Share IPD
No
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
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PubMed Identifier
34783991
Citation
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.
Results Reference
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Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder

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