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The study aims to explore whether the treatment using fNIRS-based neurofeedback training for children with attention-deficit/hyperactivity disorder (ADHD) is useful. Furthermore, the study hopes to evaluate whether the use of virtual reality (VR) technology will have an impact on the treatment's effectiveness.
The program includes the following components:
Participants will be randomly assigned to one of three intervention groups: the neurofeedback with virtual reality (VR) group, the 2D neurofeedback group (with no VR technology applied), and the VR without neurofeedback group. All participants will complete academic-related tasks in simulated lessons. Participants in the VR neurofeedback group will wear VR goggles and a neurofeedback device that measures blood oxy-hemoglobin levels in brain cortical tissue and provides feedback via visual images or auditory sounds to the participants. Those in the 2D neurofeedback group will use a computer to complete the tasks, with all other settings (e.g., neurofeedback settings) remaining the same. The VR without neurofeedback group will wear VR goggles to complete tasks, but without the neurofeedback component.
All participants will complete a total of 16 training sessions over 8 weeks (twice a week), with each session lasting approximately 35 to 60 minutes.
To investigate the intervention's effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory before the intervention (i.e., Time 1), immediately after the 8-week training (i.e., Time 2), and 2 months after the training (i.e., Time 3, a 2-month follow-up). The assessment will take around 1 hour and will be conducted at the laboratory at the University of Hong Kong. Additionally, parents and teachers will be asked to complete a questionnaire assessing children's behavior at home and at school at three time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fNIRS-NFT with VR | Experimental | The experimental group will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated using VR and participants will be asked to complete some academic-related tasks during the stimulated lessons. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants will learn to manipulate their attention, presumably by altering brain activities. |
|
| fNIRS-NFT without VR | Active Comparator | The fNIRS-NFT without VR (NFT-2D group) will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated via a computer screen and participants will be asked to complete some academic-related tasks during the stimulated lessons by pressing a remote controller provided. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants hopefully will learn to manipulate their attention, presumably by altering brain activities. |
|
| VR without fNIRS-NFT | Active Comparator | In the VR without fNIRS-NFT Training, we have designed a virtual reality classroom scenario modeled and children are asked to complete academic tasks in the VR setting but no neurofeedback will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fNIRS-based neurofeedback | Behavioral | fNIRS-based neurofeedback is provided during a simulated classroom scenario where the child participants are asked to learn to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's ADHD symptoms | Parents will be asked to complete the Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) measuring children's inattentive, hyperactive and impulsive symptoms with a 4-point Likert scale (ranges from 0 to 3). The minimum total score is 0 while the maximum total score is 78, with a higher score indicating a higher level of inattentive, hyperactive and impulsive symptoms. | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) |
| Children's ADHD symptoms | Parents will be asked to complete the Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) measuring children's inattentive, hyperactive and impulsive symptoms with a 4-point Likert scale (ranges from 0 to 3). The minimum total score is 0 while the maximum total score is 78, with a higher score indicating a higher level of inattentive, hyperactive and impulsive symptoms. | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) |
| Children's ADHD symptoms | Parents will be asked to complete the Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) measuring children's inattentive, hyperactive and impulsive symptoms with a 4-point Likert scale (ranges from 0 to 3). The minimum total score is 0 while the maximum total score is 78, with a higher score indicating a higher level of inattentive, hyperactive and impulsive symptoms. | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Conners Continuous Performance Test 3rd Edition (CPT 3) | A standardized computerized test on sustained attention and inhibitory control | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) |
| Conners Continuous Performance Test 3rd Edition (CPT 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Children's enjoyment of the training | Children's enjoyment of the training will be evaluated using the Cognitive Absorption Scale (CAS) using a 7-point Likert scale (ranges from 1 to 7), which includes four dimensions: temporal dissociation, focused immersion, heightened enjoyment, and curiosity. The total score of this scale ranges from 7 to 119, with a higher score indicating a higher level of children's enjoyment of the training. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kar-man Kathy Shum, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
The de-identified individual participant data collected during the trial will be available upon reasonable request.
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Beginning immediately after publication and ending 5 years after publication.
To gain access, requestors will need to provide a clear research aim or methodological sound research plan directed to the principal investigator (kkmshum@hku.hk).
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality), twice per week, each lasting 1 hour.
Comparative group 1: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training without virtual reality(VR) technology, twice per week, each lasting 1 hour.
Comparative group 2: receives 8-week training using VR technology (without neurofeedback) twice per week, each lasting 1 hour.
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|
| Virtual Reality Simulated Classroom | Behavioral | A simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom. |
|
A standardized computerized test on sustained attention and inhibitory control |
| Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) |
| Conners Continuous Performance Test 3rd Edition (CPT 3) | A standardized computerized test on sustained attention and inhibitory control | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) |
| Functional NIRS | The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS. | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) |
| Functional NIRS | The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS. | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) |
| Functional NIRS | The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS. | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) |
| Number subtest of Children's Memory Scale (CMS) | A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30. | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) |
| Number subtest of Children's Memory Scale (CMS) | A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30. | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) |
| Number subtest of Children's Memory Scale (CMS) | A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30. | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) |
| Behavioural ratings on children's executive functions | Parents and teachers will be asked to complete Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) |
| Behavioural ratings on children's executive functions | Parents and teachers will be asked to complete Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) |
| Behavioural ratings on children's executive functions | Parents and teachers will be asked to complete Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) |
| Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) |
| Feasibility of conducting VR training within children | Children's symptoms of cybersickness (e.g., nausea, fatigue, eye strain) will be measured using the Simulator Sickness Questionnaire (SSQ) after completing every training session, using a 4-point Likert scale (ranges from 0 to 3). The minimum weighted total score of this scale is 0 and the maximum weighted total score is 235.62, with a higher score indicating a higher level of symptoms of cybersickness. | Up to 8 to 10 weeks (within the intervention period) |