Computerized Eye-tracking Attention Training for Children With Special Needs
Primary Purpose
ADHD, ASD, Learning Disorders
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Computerized training program
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring Sustained attention, Impulse control, Eye-tracking, Special needs, Computerized training
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children with mental retardation will be excluded
Sites / Locations
- Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control Group
Arm Description
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
Computerized program
Outcomes
Primary Outcome Measures
Flanker Inhibitory Control and Attention Test (Cognitive Test)
flanker inhibitory control and attention test to assess their attention
Dimensional Change Card Sort Test (Psychological Test Battery)
the Dimensional Change Card Sort Test to measure executive function
Secondary Outcome Measures
Full Information
NCT ID
NCT04178421
First Posted
November 22, 2019
Last Updated
November 25, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04178421
Brief Title
Computerized Eye-tracking Attention Training for Children With Special Needs
Official Title
Computerized Eye-tracking Attention Training for Children With Special Needs
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, ASD, Learning Disorders
Keywords
Sustained attention, Impulse control, Eye-tracking, Special needs, Computerized training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Computerized program
Intervention Type
Other
Intervention Name(s)
Computerized training program
Intervention Description
Eye-gaze fixation computer based training program
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Computerized program
Intervention Description
Pac-Man, Zookeeper, Tetris
Primary Outcome Measure Information:
Title
Flanker Inhibitory Control and Attention Test (Cognitive Test)
Description
flanker inhibitory control and attention test to assess their attention
Time Frame
through study completion, an average of 2 year
Title
Dimensional Change Card Sort Test (Psychological Test Battery)
Description
the Dimensional Change Card Sort Test to measure executive function
Time Frame
through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Children with mental retardation will be excluded
Facility Information:
Facility Name
Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Computerized Eye-tracking Attention Training for Children With Special Needs
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