Autism Spectrum DisorderNCT04308915
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
A study testing Game-based cognitive training in people with Autism Spectrum Disorder, run by Indian Institute of Technology Kanpur at 1 site in India.
Trial summary
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. Several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Game-based cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 6 Sep 2018to 31 Oct 2018
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD
Who cannot join
- Inability to use smartphones/tablets
- Serious intellectual disabilities.
- Sensory impairment
Trial locations and contacts
1 site in 1 country.
About this study
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. Several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. A meta-analysis of the studies aimed at evaluating working memory (WM) in autistic population suggested deficits in visual and verbal aspects of WM. Working memory training has also been studied in other neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD). The study includes development of mobile-based games for training WM and other cognitive skills in patients and the evaluation of such training in reducing symptoms of ASD. These games may also be useful for other neurodevelopmental disorders.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Game-based cognitive training
- Keywords
- digital intervention, serious games
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based cognitive trainingBehavioural
A suite of 5 games is presented to the participants for training working memory
| Study group | Role | What they receive |
|---|---|---|
| Game-based training | Experimental | Participants play games for cognitive training Receives: Behavioral: Game-based cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corsi Task Block Span
It is an indicator of working memory. The value ranges between 0 and 9. Higher values mean better outcome.
Measured: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
Corsi Task Total Score
It is an indicator of working memory. The minimum value is 0, the maximum value has no limit. Higher values mean better outcome.
Measured: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
Secondary outcomes (1)
Autism Treatment Evaluation Checklist Total Score
Autism Treatment Evaluation Checklist is a measure to evaluate treatments for Autism. The total score ranges between 0 and 179. Higher values mean better outcome.
Measured: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start6 Sep 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Institute of Technology Kanpur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308915
- Sponsor's protocol ID
- IITK/IEC/2017-18II/2
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Vries M, Prins PJ, Schmand BA, Geurts HM. Working memory and cognitive flexibility-training for children with an autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2015 May;56(5):566-76. doi: 10.1111/jcpp.12324. Epub 2014 Sep 26.
PubMed 25256627
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT04308915
- Acronym / sponsor ID
- IITK/IEC/2017-18II/2
- Conditions
- Autism Spectrum Disorder
- Keywords
- digital intervention, serious games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Indian Institute of Technology KanpurUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 16 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.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. Several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. A meta-analysis of the studies aimed at evaluating working memory (WM) in autistic population suggested deficits in visual and verbal aspects of WM. Working memory training has also been studied in other neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD). The study includes development of mobile-based games for training WM and other cognitive skills in patients and the evaluation of such training in reducing symptoms of ASD. These games may also be useful for other neurodevelopmental disorders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Game-based training | Experimental | Behavioral: Game-based cognitive trainingParticipants play games for cognitive training |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD
Key exclusion criteria (3 listed)
- Inability to use smartphones/tablets
- Serious intellectual disabilities.
- Sensory impairment
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 |
|---|---|---|
| Game-based cognitive trainingA suite of 5 games is presented to the participants for training working memory | Behavioural | Game-based training |
Primary outcome
Corsi Task Block Span
Time frame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
It is an indicator of working memory. The value ranges between 0 and 9. Higher values mean better outcome.
Corsi Task Total Score
Time frame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
It is an indicator of working memory. The minimum value is 0, the maximum value has no limit. Higher values mean better outcome.
1 secondary outcome
Autism Treatment Evaluation Checklist Total Score
Time frame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
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 17 Mar 2020.
- Background: PubMed 25256627de Vries M, Prins PJ, Schmand BA, Geurts HM. Working memory and cognitive flexibility-training for children with an autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2015 May;56(5):566-76. doi: 10.1111/jcpp.12324. Epub 2014 Sep 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based cognitive training in people with Autism Spectrum Disorder, run by Indian Institute of Technology Kanpur at 1 site in India.
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 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: finished, as of the sponsor's last update on 17 Mar 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 India. 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?
Corsi Task Block Span (time frame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)). 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?
On the ClinicalTrials.gov record for NCT04308915, which also lists 1 linked publication.
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 17 Mar 2020.