NCT04178421

Brief Summary

Children with special needs (e.g. autistic spectrum disorder, attention deficit hyperactivity disorder) are found to have sustained attention problems. Several behavioral interventions have been carried out in the past to improve this situation. However, these interventions are often involved a high administration cost. Recently, researchers have been focusing on training the eye gaze fixation using the eye-tracking training games, as some of the research studies reported a correlation between atypical eye gaze patterns with poor sustained attention. The objective of the present study is to evaluate the effectiveness of a computerized eye-tracking attention training. Two batches of 48 primary school students will be recruited from email and the subject pool of the Department of Psychology of The Chinese University of Hong Kong. Participants are dividedly randomly and equally into either intervention or control group. Participants in both groups will undergo pre- and post-assessments measuring the executive function and attention before and after the intervention, respectively. However, there will be eight eye-tracking training sessions for the intervention group, but only the assessments are received in the control group. It is hypothesized that after the training, the performance of the training games and assessments will improve, indicated by increasing accuracy rates, as well as the reaction time of the tasks. The results would provide important information on the value of computerized eye gaze training and would guide the direction of interventions that target on improving the sustained attention and impulse control of children with special needs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

November 22, 2019

Last Update Submit

November 25, 2019

Conditions

Keywords

Sustained attentionImpulse controlEye-trackingSpecial needsComputerized training

Outcome Measures

Primary Outcomes (2)

  • Flanker Inhibitory Control and Attention Test (Cognitive Test)

    flanker inhibitory control and attention test to assess their attention

    through study completion, an average of 2 year

  • Dimensional Change Card Sort Test (Psychological Test Battery)

    the Dimensional Change Card Sort Test to measure executive function

    through study completion, an average of 2 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

A computerized eye -tracking program training the eye gaze fixation with the target to improve impulse control and sustained attention of children with special needs

Other: Computerized training program

Control Group

PLACEBO COMPARATOR

Computerized program

Other: Placebo

Interventions

Eye-gaze fixation computer based training program

Experimental Group
PlaceboOTHER

Pac-Man, Zookeeper, Tetris

Also known as: Computerized program
Control Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • a total of 96 primary school children (aged between 6 to 12 years) with special needs, defined by psychological disorders such as ASD, ADHD, ADD, and Dyslexia

You may not qualify if:

  • Children with mental retardation will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityLearning Disabilities

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Chan Sui-yin Agnes

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 26, 2019

Study Start

September 1, 2018

Primary Completion

August 30, 2019

Study Completion

September 10, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations