fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

Study Overview
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Brief Summary
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The study aims to explore the effectiveness of neurofeedback training on improving attention and inhibitory control of children with attention-deficit/hyperactivity disorder (ADHD) in Hong Kong. This study will contribute to the current understanding of the alternative treatments for ADHD, and hopefully help to mobilize more resources to support children with ADHD. The programme includes the following components: Participants will be randomly assigned to the neurofeedback training group (with virtual reality [VR] technology applied), the computerized cognitive training group, or the waitlist control group. All participants will complete a total of 16 training sessions in 8 weeks (twice a week), and each session will last around 35 to 60 mins. To investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to 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 it will be conducted at the laboratory at the University of Hong Kong. Also, parents and teachers will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 timepoints.

Official Title
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Randomized Controlled Trials of the Effects of Near-infrared Spectroscopy (fNIRS) Neurofeedback Training Coupled With Virtual Reality Technology in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: fNIRS Neurofeedback-VR Training
* Behavioral: Computerized Cognitive Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 7- 12 Clinical diagnosis of ADHD Significant teacher- or parent-reported attention problems during screening Exclusion Criteria: IQ under 70, as measured on Raven's Progressive Matrices Hearing, visual, or physical impairments that might hinder participation in the training and assessment activities Clinical diagnosis and suspected cases of Autism Spectrum Disorder (ASD) Prior or current participation in NFT Current participation in a psychotherapeutic treatment

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality) in Phase 1, twice per week, each lasts 1 hour. Active control group: receives 8-weeks computerized cognitive training in Phase 1, twice per week, each lasts 35 minutes. Waitlist control group: either receives 8-weeks fNIRS neurofeedback training (coupled with virtual reality) or computerized cognitive training in Phase 2 (i.e., after the completion of training for intervention group and active control group).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group: fNIRS Neurofeedback-VR Training Group<br>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. | Behavioral: fNIRS Neurofeedback-VR Training<br>* In the fNIRS Neurofeedback-VR Training, we have designed a classroom scenario modeled and children are expected to learn how to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.<br>|
| Active Comparator: Active Control Group: Computerized Cognitive Training Group<br>The computerized cognitive training group will receive 16 sessions of training, 35 minutes each, conducted twice per week over a period of 8 weeks. Participants will be asked to complete a set of computerized tasks using Cogmed, a digital training programme which is proven to enhance working memory and attention level in children. | Behavioral: Computerized Cognitive Training<br>* In the Computerized Cognitive Training, children will complete a range of tasks covering attention control and working memory using a conventional training programme, namely Cogmed.<br>|
| Other: Waitlist Control Group<br>The waitlist control group will not receive any intervention until the intervention arms complete their training. Depending on the availability, either the fNIRS Neurofeedback-VR Training or the Computerized Cognitive Training will be offered to this group. | Behavioral: fNIRS Neurofeedback-VR Training<br>* In the fNIRS Neurofeedback-VR Training, we have designed a classroom scenario modeled and children are expected to learn how to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.<br>Behavioral: Computerized Cognitive Training<br>* In the Computerized Cognitive Training, children will complete a range of tasks covering attention control and working memory using a conventional training programme, namely Cogmed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 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) | 
| 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) | 
| Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH) | A measure of attentional control/switching that requires the child to make cognitive reversals. | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) | 
| Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH) | A measure of attentional control/switching that requires the child to make cognitive reversals. | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) | 
| Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH) | A measure of attentional control/switching that requires the child to make cognitive reversals. | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) | 
| Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH) | A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward. | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) | 
| Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH) | A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward. | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) | 
| Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH) | A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward. | 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 throughout the training sessions and direct assessments 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 throughout the training sessions and direct assessments using functional NIRS. | Up to 8 to 10 weeks (within the intervention period) | 
| Functional NIRS | The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments 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 throughout the training sessions and direct assessments using functional NIRS. | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's ADHD symptoms | Parents and teachers 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 and teachers 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 and teachers 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) | 
| 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) | 
| Children's classroom behaviours | Children's classroom behaviours, including their engagement and off-task behaviours, will be measured using a classroom observation scale based on the Behavioral Observation of Students in Schools (BOSS) developed by our research lab through naturalistic observation at schools. A proportion of participants will be selected randomly to undergo the classroom observation. The total scores for children's engagement and off-task behaviours ranges from 0 to 30, with a higher score indicating a higher level of engagement and off-task behaviours in class. | Pre-intervention Assessment (within 4 weeks before the commencement of the intervention) | 
| Children's classroom behaviours | Children's classroom behaviours, including their engagement and off-task behaviours, will be measured using a classroom observation scale based on the Behavioral Observation of Students in Schools (BOSS) developed by our research lab through naturalistic observation at schools. A proportion of participants will be selected randomly to undergo the classroom observation. The total scores for children's engagement and off-task behaviours ranges from 0 to 30, with a higher score indicating a higher level of engagement and off-task behaviours in class. | Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention) | 
| Children's classroom behaviours | Children's classroom behaviours, including their engagement and off-task behaviours, will be measured using a classroom observation scale based on the Behavioral Observation of Students in Schools (BOSS) developed by our research lab through naturalistic observation at schools. A proportion of participants will be selected randomly to undergo the classroom observation. The scores for children's engagement and off-task behaviours ranges from 0 to 30, with a higher score indicating a higher level of engagement and off-task behaviours in class. | Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fNIRS Neurofeedback Training, Virtual Reality, Children with ADHD