- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05962047
Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder
Use of Augmented Reality for Restricted and Repetitive Behavior and Executive Function of Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
AL
-
Islamabad, AL, Pakistan, 44000
- Child Development Center - Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 2
Traditional therapy
|
Traditional therapy based on play activities utilizing blocks, colors, Velcro-based toys.
|
|
Experimental: Group 1
Augmented Reality games
|
Participants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Developmental Behaviour Checklist (DBC)
Time Frame: After 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repetitive Behaviors Scale-Revised (RBS-R)
Time Frame: After 8 weeks
|
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.
|
After 8 weeks
|
|
The flexibility Scale
Time Frame: After 8 weeks
|
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.
|
After 8 weeks
|
|
Digital span memory test
Time Frame: After 8 weeks
|
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
|
After 8 weeks
|
|
The Stroop test
Time Frame: After 8 weeks
|
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. |
After 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suman Sheraz, PhD*, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F723 - Project A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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