fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

Not Applicable

Recruiting

• Conditions: ADHD

• Registration Number: NCT05906485
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-01-11
• Study Completion: 2026-01-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Conners Continuous Performance Test 3rd Edition (CPT 3)	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	A standardized computerized test on sustained attention and inhibitory control
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.
Number subtest of Children's Memory Scale (CMS)	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	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.
Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	A measure of attentional control/switching that requires the child to make cognitive reversals.
Functional NIRS	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.

Secondary Outcome Measures

Name	Time	Method
Behavioural ratings on children's executive functions	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	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
Children's ADHD symptoms	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)	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.

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong