Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders

March 13, 2020 updated by: Indian Institute of Technology Kanpur
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208016
        • Indian Institute of Technology Kanpur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Game-based training
Participants play games for cognitive training
Behavioral: Game-based cognitive training
A suite of 5 games is presented to the participants for training working memory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indian Institute of Technology Kanpur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 6, 2018

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IITK/IEC/2017-18II/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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