Autism Spectrum DisorderNCT05962047
Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder
A study testing Games of WonderTree Augmented Reality and Traditional therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Games of WonderTree Augmented Reality and Traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jul 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.
Who cannot join
- Sensory issues and patients on medication
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Child Development Center - Riphah International University
Islamabad, AL, 44000
About this study
Official title: Use of Augmented Reality for Restricted and Repetitive Behavior and Executive Function of Children With Autism Spectrum Disorder
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
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Games of WonderTree Augmented Reality, Traditional therapy
- Keywords
- Augmented Reality, Behaviour, Executive function
- Medical subject headings
- Autism Spectrum Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Games of WonderTree Augmented RealityOther
Participants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree
Traditional therapyOther
Traditional therapy based on play activities utilizing blocks, colors, Velcro-based toys.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Augmented Reality games Receives: Other: Games of WonderTree Augmented Reality |
| Group 2 | Active comparator | Traditional therapy Receives: Other: Traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 8 weeks
Secondary outcomes (4)
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.
Measured: After 8 weeks
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.
Measured: After 8 weeks
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
Measured: After 8 weeks
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.
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start25 Jul 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962047
- Sponsor's protocol ID
- F723 - Project A
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32847074Dechsling 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.
PubMed 34783991
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Augmented Reality for Restricted and Repetitive Behavior and Executive Function of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05962047
- Acronym / sponsor ID
- F723 - Project A
- Conditions
- Autism Spectrum Disorder
- Keywords
- Augmented Reality, Behaviour, Executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Games of WonderTree Augmented RealityAugmented Reality games |
| Group 2 | Active comparator | Other: Traditional therapyTraditional therapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.
Key exclusion criteria (1 listed)
- Sensory issues and patients on medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Games of WonderTree Augmented RealityParticipants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree | Other | Group 1 |
| Traditional therapyTraditional therapy based on play activities utilizing blocks, colors, Velcro-based toys. | Other | Group 2 |
Primary outcome
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
4 secondary outcomes
Repetitive Behaviors Scale-Revised (RBS-R)
Time frame: After 8 weeks
The flexibility Scale
Time frame: After 8 weeks
Digital span memory test
Time frame: After 8 weeks
The Stroop test
Time frame: After 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 32847074Berenguer 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.
- Background: PubMed 34783991Dechsling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Games of WonderTree Augmented Reality and Traditional therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Behaviour Checklist (DBC) (time frame: After 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.