ADHDNCT04178421
Computerized Eye-tracking Attention Training for Children With Special Needs
A study testing Computerized training program in people with ADHD and ASD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD, ASD, Learning Disorders
- What is being tested?
- Computerized training program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2018to 10 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with mental retardation will be excluded
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
Hong Kong
About this study
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.
- Conditions
- ADHD, ASD, Learning Disorders
- Being tested
- Computerized training program, Placebo
- Keywords
- Sustained attention, Impulse control, Eye-tracking, Special needs, Computerized training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized training programOther
Eye-gaze fixation computer based training program
PlaceboOther
Also called Computerized program
Pac-Man, Zookeeper, Tetris
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Computerized training program |
| Control Group | Placebo comparator | Computerized program Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flanker Inhibitory Control and Attention Test (Cognitive Test)
flanker inhibitory control and attention test to assess their attention
Measured: 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
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Sep 2018
- Primary completion30 Aug 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Chan Sui-yin Agnes, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178421
- Sponsor's protocol ID
- 2018-0298
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Eye-tracking Attention Training for Children With Special Needs
- ClinicalTrials.gov ID
- NCT04178421
- Acronym / sponsor ID
- 2018-0298
- Conditions
- ADHD, ASD, Learning Disorders
- Keywords
- Sustained attention, Impulse control, Eye-tracking, Special needs, Computerized training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Computerized training programA computerized eye -tracking program training the eye gaze fixation with the target to improve impulse control and sustained attention of children with special needs |
| Control Group | Placebo comparator | Other: PlaceboComputerized program |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children with mental retardation will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized training programEye-gaze fixation computer based training program | Other | Experimental Group |
| PlaceboAlso: Computerized programPac-Man, Zookeeper, Tetris | Other | Control Group |
Primary outcome
Flanker Inhibitory Control and Attention Test (Cognitive Test)
Time frame: through study completion, an average of 2 year
flanker inhibitory control and attention test to assess their attention
Dimensional Change Card Sort Test (Psychological Test Battery)
Time frame: through study completion, an average of 2 year
the Dimensional Change Card Sort Test to measure executive function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized training program in people with ADHD and ASD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flanker Inhibitory Control and Attention Test (Cognitive Test) (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.