NCT04308915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 11, 2020

Last Update Submit

March 13, 2020

Conditions

Keywords

digital interventionserious games

Outcome Measures

Primary Outcomes (2)

  • Corsi Task Block Span

    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

    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 Outcomes (1)

  • Autism Treatment Evaluation Checklist Total Score

    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)

Study Arms (1)

Game-based training

EXPERIMENTAL

Participants play games for cognitive training

Behavioral: Game-based cognitive training

Interventions

A suite of 5 games is presented to the participants for training working memory

Game-based training

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD

You may not qualify if:

  • Inability to use smartphones/tablets
  • Serious intellectual disabilities.
  • Sensory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Institute of Technology Kanpur

Kanpur, Uttar Pradesh, 208016, India

Location

Related Publications (1)

  • 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.

    PMID: 25256627BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 16, 2020

Study Start

September 6, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations