Autism Spectrum DisorderNCT04295746
Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game
A study testing Serious Game ShopAut in people with Autism Spectrum Disorder, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the efficacy of a rehabilitation intervention for people with Autism Spectrum Disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Serious Game ShopAut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Sep 2021
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- clinical diagnosis of Autism Spectrum Disorder, in keeping with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- chronological age between 8 and 16 years
- a rehabilitation plan already underway in accordance with the study's goals
- Representatives of parental authority who gave informed written consent
- native Italian speakers
Who cannot join
- no physical impairments
- participant to another research protocol
- known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Naples Federico II - Centro Medico Riabilitativo Pompei
Naples
About this study
This study evaluates the efficacy of a rehabilitation intervention for people with Autism Spectrum Disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket.
Read the detailed description
Serious games are innovative computer-based interventions to support children and adults with Autism Spectrum Disorder (ASD). However, few studies have assessed the efficacy of these interventions in real-life contexts. The present study investigates the generalisation of daily living skills related to shopping activities after a rehabilitation intervention administered via a personalised serious game (ShopAut). The underlying hypothesis of this study is that training with an individualised serious game can improve performance in a real-life environment. In order to prove this hypothesis, a small sample of subjects with ASD will play an individualised serious game, ShopAut, for ten sessions. Subjects will undergo real-life experiences in a supermarket pre- and post-virtual training to determine whether there had been a generalisation of skills from the virtual environment to the real environment. Improvements in skills and performance in the real shopping activity are evaluated using specific tools.
The serious game ShopAut is developed integrating an individualised design that provides both the personalisation of the game's scenario, contents, difficulty, and user interface; and the customisation of game modes, player perspectives, and input devices. It is a three-dimensional game that provides a realistic shopping experience where the player can practice and engage with, above all, shopping activities, experiment their problem-solving skills, and take on unexpected events.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Serious Game ShopAut
- Keywords
- autism, serious game
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious Game ShopAutOther
The serious game ShopAut, is a three-dimensional game conceptually based on classic 3D life simulation games. ShopAut aims to teach players the procedure of a shopping activity; to reinforce object categorization and recognition in a supermarket; to improve attention, orientation, and problem-solving skills; and to help the player engage in simple economic transactions.
The intervention provides a virtual training with ShopAut to train, experiment, and practice behaviours and actions that can be then transferred in real-life contexts.
| Study group | Role | What they receive |
|---|---|---|
| Serious Game ShopAut | Experimental | Each participant played 10 game sessions, one per week, for no more than 30 minutes. Receives: Other: Serious Game ShopAut |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 11 weeks
In order to describe the participants' functioning in the supermarket, an ad hoc evaluation form was created based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY). The form follows the ICF-CY scale so higher scores mean a worse outcome.
Measured: baseline and 11 weeks
change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months
The Vineland Adaptive Behavior Scale II (VABS-II) is a standardized paediatric functional assessment tool. The VABS-II offers a way to measure personal and social self-sufficiency in real-life situations and to observe how these cognitive abilities impact the autonomy management process when put into practice. The VABS-II consists in a semi-structured interview with the parents. Higher scores mean a better outcome.
Measured: baseline and 6 months
Secondary outcomes (2)
Vineland Adaptive Behavior Scale II (VABS-II) at 12 months
The Vineland Adaptive Behavior Scale II (VABS-II) is a standardized paediatric functional assessment tool. The VABS-II offers a way to measure personal and social self-sufficiency in real-life situations and to observe how these cognitive abilities impact the autonomy management process when put into practice. The VABS-II consists in a semi-structured interview with the parents. Higher scores mean a better outcome.
Measured: 12 months
a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 12 months
In order to describe the participants' functioning in the supermarket, an ad hoc evaluation form was created based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY). The form follows the ICF-CY scale so higher scores mean a worse outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Mar 2019
- Primary completion30 Nov 2019
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersilia Vallefuoco, Federico II University
- Investigators
- Alessandro Pepino, Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295746
- Sponsor's protocol ID
- 9820
- Status last verified
- Jul 2020
- First submitted
- 29 Feb 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game
- ClinicalTrials.gov ID
- NCT04295746
- Acronym / sponsor ID
- 9820
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, serious game
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Mar 2020 (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.
This study evaluates the efficacy of a rehabilitation intervention for people with Autism Spectrum Disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket.
Detailed description
Serious games are innovative computer-based interventions to support children and adults with Autism Spectrum Disorder (ASD). However, few studies have assessed the efficacy of these interventions in real-life contexts. The present study investigates the generalisation of daily living skills related to shopping activities after a rehabilitation intervention administered via a personalised serious game (ShopAut). The underlying hypothesis of this study is that training with an individualised serious game can improve performance in a real-life environment. In order to prove this hypothesis, a small sample of subjects with ASD will play an individualised serious game, ShopAut, for ten sessions. Subjects will undergo real-life experiences in a supermarket pre- and post-virtual training to determine whether there had been a generalisation of skills from the virtual environment to the real environment. Improvements in skills and performance in the real shopping activity are evaluated using specific tools.
The serious game ShopAut is developed integrating an individualised design that provides both the personalisation of the game's scenario, contents, difficulty, and user interface; and the customisation of game modes, player perspectives, and input devices. It is a three-dimensional game that provides a realistic shopping experience where the player can practice and engage with, above all, shopping activities, experiment their problem-solving skills, and take on unexpected events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serious Game ShopAut | Experimental | Other: Serious Game ShopAutEach participant played 10 game sessions, one per week, for no more than 30 minutes. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- clinical diagnosis of Autism Spectrum Disorder, in keeping with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- chronological age between 8 and 16 years
- a rehabilitation plan already underway in accordance with the study's goals
- Representatives of parental authority who gave informed written consent
- native Italian speakers
Key exclusion criteria (3 listed)
- no physical impairments
- participant to another research protocol
- known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities
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 |
|---|---|---|
| Serious Game ShopAutThe serious game ShopAut, is a three-dimensional game conceptually based on classic 3D life simulation games. ShopAut aims to teach players the procedure of a shopping activity; to reinforce object categorization and recognition in a supermarket; to improve attention, orientation, and problem-solving skills; and to help the player engage in simple economic transactions. The intervention provides a virtual training with ShopAut to train, experiment, and practice behaviours and actions that can be then transferred in real-life contexts. | Other | Serious Game ShopAut |
Primary outcome
change from baseline in a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 11 weeks
Time frame: baseline and 11 weeks
In order to describe the participants' functioning in the supermarket, an ad hoc evaluation form was created based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY). The form follows the ICF-CY scale so higher scores mean a worse outcome.
change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months
Time frame: baseline and 6 months
The Vineland Adaptive Behavior Scale II (VABS-II) is a standardized paediatric functional assessment tool. The VABS-II offers a way to measure personal and social self-sufficiency in real-life situations and to observe how these cognitive abilities impact the autonomy management process when put into practice. The VABS-II consists in a semi-structured interview with the parents. Higher scores mean a better outcome.
2 secondary outcomes
Vineland Adaptive Behavior Scale II (VABS-II) at 12 months
Time frame: 12 months
a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- 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.
Alessandro Pepino study director
Federico II 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 Serious Game ShopAut in people with Autism Spectrum Disorder, run by Federico II University at 1 site in Italy.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. 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 Italy. 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?
Results are not available in the source record.
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?
change from baseline in a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 11 weeks (time frame: baseline and 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2020.