Back to resultsMobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Game-based cognitive training
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring digital intervention, serious games
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD
Exclusion Criteria:
- Inability to use smartphones/tablets
- Serious intellectual disabilities.
- Sensory impairment
Sites / Locations
- Indian Institute of Technology Kanpur
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Game-based training
Arm Description
Participants play games for cognitive training
Outcomes
Primary Outcome Measures
Corsi Task Block Span
It is an indicator of working memory. The value ranges between 0 and 9. Higher values mean better outcome.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04308915
First Posted
March 11, 2020
Last Updated
March 13, 2020
Sponsor
Indian Institute of Technology Kanpur
1. Study Identification
Unique Protocol Identification Number
NCT04308915
Brief Title
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
Official Title
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indian Institute of Technology Kanpur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
digital intervention, serious games
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Game-based training
Arm Type
Experimental
Arm Description
Participants play games for cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Game-based cognitive training
Intervention Description
A suite of 5 games is presented to the participants for training working memory
Primary Outcome Measure Information:
Title
Corsi Task Block Span
Description
It is an indicator of working memory. The value ranges between 0 and 9. Higher values mean better outcome.
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)
Title
Corsi Task Total Score
Description
It is an indicator of working memory. The minimum value is 0, the maximum value has no limit. Higher values mean better outcome.
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)
Secondary Outcome Measure Information:
Title
Autism Treatment Evaluation Checklist Total Score
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD
Exclusion Criteria:
Inability to use smartphones/tablets
Serious intellectual disabilities.
Sensory impairment
Facility Information:
Facility Name
Indian Institute of Technology Kanpur
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208016
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25256627
Citation
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.
Results Reference
background
Learn more about this trial
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
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