Attention Deficit Hyperactivity DisorderNCT07392463
Artificial Intelligence Versus Virtual Reality Teaching for Children and Adolescents With ADHD
A study testing Artificial Intelligence-Assisted Teaching and Virtual Reality-Based Smart Classroom Teaching in people with Attention Deficit Hyperactivity Disorder, run by Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province at 1 site in China.
Trial summary
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children and adolescents and is often associated with difficulties in attention, behavior regulation, and executive functioning. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Artificial Intelligence-Assisted Teaching and Virtual Reality-Based Smart Classroom Teaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Sep 2025
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged 8 to 15 years.
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by two qualified child psychiatrists.
- Total score of 25 or higher on the ADHD Rating Scale (ADHD-RS).
- Intelligence quotient (IQ) of 80 or above as assessed by the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
- Stable clinical status for at least 30 days prior to enrollment, with adherence to standard first-line or second-line treatment regimens, and no planned changes in treatment during the study period.
- Ability to participate in structured digital teaching sessions.
- Written informed consent provided by a parent or legal guardian, with assent obtained from the participant when appropriate.
Who cannot join
- Presence of neurodevelopmental or neurological disorders other than ADHD, such as cerebral palsy or epilepsy.
- Diagnosis of severe psychiatric disorders, including schizophrenia.
- Significant sensory impairments (e.g., hearing impairment) that could interfere with study participation.
- Lack of response to two or more different classes of ADHD medications.
- History of suspected substance abuse or dependence within the past 6 months.
- Physical conditions or motor impairments that would prevent participation in the teaching interventions.
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- Current suicidal ideation or severe suicidal behavior as determined by the investigator.
- Receipt of other structured psychological or educational interventions during the study period.
- Any other condition that, in the opinion of the investigator, would make participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Hongxinkang New Traditional Chinese Medicine Hospital, Tongren
Tongren, Guizhou, 554300
About this study
Official title: Comparative Effects of Artificial Intelligence Teaching and Immersive Virtual Reality Smart Classroom Teaching on Children and Adolescents With ADHD: A Randomized Controlled Trial
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children and adolescents and is often associated with difficulties in attention, behavior regulation, and executive functioning. In addition to medication, non-pharmacological interventions, including digital and technology-assisted educational approaches, have gained increasing interest.
This randomized controlled trial compared the effects of artificial intelligence (AI)-assisted teaching and immersive virtual reality (VR)-based smart classroom teaching on core ADHD symptoms and executive function in children and adolescents with ADHD. A total of 90 participants aged 8 to 15 years who met diagnostic criteria for ADHD were randomly assigned to either an AI-assisted teaching group or a VR-based teaching group.
Read more
Both groups received structured teaching interventions for 12 weeks, three sessions per week, with each session lasting 45 minutes. ADHD symptoms and executive function were assessed before the intervention, at the end of the intervention, and at a 3-month follow-up using validated rating scales.
The purpose of this study was to evaluate and compare the effectiveness of these two digital teaching approaches and to provide evidence for personalized, non-pharmacological educational interventions for children and adolescents with ADHD.
Read the detailed description
This study was an open-label, randomized, parallel-group controlled trial designed to compare the effects of artificial intelligence (AI)-assisted teaching and immersive virtual reality (VR)-based smart classroom teaching on core symptoms and executive function in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).
Participants aged 8 to 15 years were recruited from an outpatient ADHD clinic and were required to meet diagnostic criteria for ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Eligible participants were randomly assigned in a 1:1 ratio to either the AI-assisted teaching group or the VR-based teaching group using a computer-generated randomization sequence prepared by an independent statistician. Due to the nature of the digital interventions, participants were not blinded to group allocation; however, outcome assessments were conducted by trained evaluators who were blinded to treatment assignment.
Both groups received structured teaching interventions for 12 weeks, with three sessions per week and each session lasting approximately 45 minutes. The AI-assisted teaching intervention was delivered using a tablet-based adaptive learning system incorporating eye-tracking, behavioral analysis, and real-time feedback to dynamically adjust task difficulty and learning pace based on individual performance and attention patterns. The VR-based teaching intervention was delivered using immersive virtual reality technology to simulate classroom and task-based learning scenarios, with an emphasis on interactive learning and emotional regulation in a low-distraction environment.
Primary outcomes included changes in core ADHD symptoms as measured by the ADHD Rating Scale (ADHD-RS). Secondary outcomes included changes in executive function assessed using the Behavior Rating Inventory of Executive Function (BRIEF), parent-report version. Outcome measures were assessed at baseline prior to intervention initiation, at the end of the 12-week intervention period, and at a 3-month post-intervention follow-up.
All study procedures were approved by the Ethics Committee of Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, and written informed consent was obtained from parents or legal guardians, with assent obtained from participating children when appropriate. The study was conducted in accordance with the principles of the Declaration of Helsinki.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Artificial Intelligence-Assisted Teaching, Virtual Reality-Based Smart Classroom Teaching
- Keywords
- ADHD, Artificial Intelligence, Virtual Reality, Digital Education, Executive Function, Children and Adolescents, Randomized Controlled Trial, Non-Pharmacological Intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Assisted TeachingBehavioural
A behavioral digital teaching intervention delivered through an artificial intelligence-assisted adaptive learning system. The system dynamically adjusted task difficulty and learning pace based on individual performance and attention-related behavioral data and provided real-time feedback during learning activities. The intervention was administered for 12 weeks, three sessions per week, with each session lasting approximately 45 minutes.
Virtual Reality-Based Smart Classroom TeachingBehavioural
A behavioral teaching intervention delivered using immersive virtual reality technology to simulate interactive classroom and task-based learning scenarios. Participants engaged in structured learning activities within a low-distraction virtual environment designed to enhance attention and engagement. The intervention was conducted for 12 weeks, three sessions per week, with each session lasting approximately 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Teaching Group | Experimental | Participants assigned to this arm received artificial intelligence-assisted teaching delivered through a tablet-based adaptive learning system. The intervention was conducted for 12 weeks, with three sessions per week and each session lasting approximately 45 minutes. The system incorporated real-time feedback and adaptive task adjustment based on individual learning performance and attention patterns. Receives: Behavioral: Artificial Intelligence-Assisted Teaching |
| Virtual Reality Smart Classroom Group | Experimental | Participants assigned to this arm received immersive virtual reality-based smart classroom teaching. The intervention was delivered using VR technology to simulate interactive learning scenarios in a low-distraction environment. The program was conducted for 12 weeks, with three sessions per week and each session lasting approximately 45 minutes. Receives: Behavioral: Virtual Reality-Based Smart Classroom Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Core ADHD Symptoms Measured by the ADHD Rating Scale (ADHD-RS)
Core symptoms of attention-deficit/hyperactivity disorder (ADHD) were assessed using the ADHD Rating Scale (ADHD-RS), which includes subscales for inattention and hyperactivity/impulsivity. Higher scores indicate greater symptom severity. The scale was completed by trained evaluators based on standardized assessment procedures.
Measured: Baseline and at the end of the 12-week intervention period
Secondary outcomes (3)
Change in Executive Function Measured by the Behavior Rating Inventory of Executive Function (BRIEF)
Executive function was assessed using the parent-report version of the Behavior Rating Inventory of Executive Function (BRIEF), which evaluates multiple domains including inhibition, working memory, planning/organization, and emotional control. Higher scores indicate greater impairment in executive function.
Measured: Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
Change in Inattention Symptoms Measured by the ADHD Rating Scale (ADHD-RS) Inattention Subscale
Inattention symptoms were assessed using the inattention subscale of the ADHD Rating Scale (ADHD-RS). The subscale consists of items evaluating attention-related difficulties, with higher scores indicating more severe inattention symptoms.
Measured: Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
Change in Hyperactivity/Impulsivity Symptoms Measured by the ADHD Rating Scale (ADHD-RS) Hyperactivity/Impulsivity Subscale
Hyperactivity and impulsivity symptoms were assessed using the hyperactivity/impulsivity subscale of the ADHD Rating Scale (ADHD-RS). Higher scores reflect greater severity of hyperactivity and impulsivity symptoms.
Measured: Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2024
- Primary completion31 Jan 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an artificial intelligence-assisted teaching group or an immersive virtual reality-based teaching group and received the assigned intervention in parallel throughout the study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Li, Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
- Investigators
- Ning Li, PhD, Principal investigator, Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392463
- Sponsor's protocol ID
- THKX-ADHD-AI-VR-2024
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Artificial Intelligence Teaching and Immersive Virtual Reality Smart Classroom Teaching on Children and Adolescents With ADHD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07392463
- Acronym / sponsor ID
- THKX-ADHD-AI-VR-2024
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Artificial Intelligence, Virtual Reality, Digital Education, Executive Function, Children and Adolescents, Randomized Controlled Trial, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou ProvinceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 Feb 2026 (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.
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children and adolescents and is often associated with difficulties in attention, behavior regulation, and executive functioning. In addition to medication, non-pharmacological interventions, including digital and technology-assisted educational approaches, have gained increasing interest.
This randomized controlled trial compared the effects of artificial intelligence (AI)-assisted teaching and immersive virtual reality (VR)-based smart classroom teaching on core ADHD symptoms and executive function in children and adolescents with ADHD. A total of 90 participants aged 8 to 15 years who met diagnostic criteria for ADHD were randomly assigned to either an AI-assisted teaching group or a VR-based teaching group.
Both groups received structured teaching interventions for 12 weeks, three sessions per week, with each session lasting 45 minutes. ADHD symptoms and executive function were assessed before the intervention, at the end of the intervention, and at a 3-month follow-up using validated rating scales.
The purpose of this study was to evaluate and compare the effectiveness of these two digital teaching approaches and to provide evidence for personalized, non-pharmacological educational interventions for children and adolescents with ADHD.
Detailed description
This study was an open-label, randomized, parallel-group controlled trial designed to compare the effects of artificial intelligence (AI)-assisted teaching and immersive virtual reality (VR)-based smart classroom teaching on core symptoms and executive function in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).
Participants aged 8 to 15 years were recruited from an outpatient ADHD clinic and were required to meet diagnostic criteria for ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Eligible participants were randomly assigned in a 1:1 ratio to either the AI-assisted teaching group or the VR-based teaching group using a computer-generated randomization sequence prepared by an independent statistician. Due to the nature of the digital interventions, participants were not blinded to group allocation; however, outcome assessments were conducted by trained evaluators who were blinded to treatment assignment.
Both groups received structured teaching interventions for 12 weeks, with three sessions per week and each session lasting approximately 45 minutes. The AI-assisted teaching intervention was delivered using a tablet-based adaptive learning system incorporating eye-tracking, behavioral analysis, and real-time feedback to dynamically adjust task difficulty and learning pace based on individual performance and attention patterns. The VR-based teaching intervention was delivered using immersive virtual reality technology to simulate classroom and task-based learning scenarios, with an emphasis on interactive learning and emotional regulation in a low-distraction environment.
Primary outcomes included changes in core ADHD symptoms as measured by the ADHD Rating Scale (ADHD-RS). Secondary outcomes included changes in executive function assessed using the Behavior Rating Inventory of Executive Function (BRIEF), parent-report version. Outcome measures were assessed at baseline prior to intervention initiation, at the end of the 12-week intervention period, and at a 3-month post-intervention follow-up.
All study procedures were approved by the Ethics Committee of Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, and written informed consent was obtained from parents or legal guardians, with assent obtained from participating children when appropriate. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an artificial intelligence-assisted teaching group or an immersive virtual reality-based teaching group and received the assigned intervention in parallel throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Teaching Group | Experimental | Behavioral: Artificial Intelligence-Assisted TeachingParticipants assigned to this arm received artificial intelligence-assisted teaching delivered through a tablet-based adaptive learning system. The intervention was conducted for 12 weeks, with three sessions per week and each session lasting approximately 45 minutes. The system incorporated real-time feedback and adaptive task adjustment based on individual learning performance and attention patterns. |
| Virtual Reality Smart Classroom Group | Experimental | Behavioral: Virtual Reality-Based Smart Classroom TeachingParticipants assigned to this arm received immersive virtual reality-based smart classroom teaching. The intervention was delivered using VR technology to simulate interactive learning scenarios in a low-distraction environment. The program was conducted for 12 weeks, with three sessions per week and each session lasting approximately 45 minutes. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children and adolescents aged 8 to 15 years.
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by two qualified child psychiatrists.
- Total score of 25 or higher on the ADHD Rating Scale (ADHD-RS).
- Intelligence quotient (IQ) of 80 or above as assessed by the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
- Stable clinical status for at least 30 days prior to enrollment, with adherence to standard first-line or second-line treatment regimens, and no planned changes in treatment during the study period.
Key exclusion criteria (9 listed)
- Presence of neurodevelopmental or neurological disorders other than ADHD, such as cerebral palsy or epilepsy.
- Diagnosis of severe psychiatric disorders, including schizophrenia.
- Significant sensory impairments (e.g., hearing impairment) that could interfere with study participation.
- Lack of response to two or more different classes of ADHD medications.
- History of suspected substance abuse or dependence within the past 6 months.
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 |
|---|---|---|
| Artificial Intelligence-Assisted TeachingA behavioral digital teaching intervention delivered through an artificial intelligence-assisted adaptive learning system. The system dynamically adjusted task difficulty and learning pace based on individual performance and attention-related behavioral data and provided real-time feedback during learning activities. The intervention was administered for 12 weeks, three sessions per week, with each session lasting approximately 45 minutes. | Behavioural | AI-Assisted Teaching Group |
| Virtual Reality-Based Smart Classroom TeachingA behavioral teaching intervention delivered using immersive virtual reality technology to simulate interactive classroom and task-based learning scenarios. Participants engaged in structured learning activities within a low-distraction virtual environment designed to enhance attention and engagement. The intervention was conducted for 12 weeks, three sessions per week, with each session lasting approximately 45 minutes. | Behavioural | Virtual Reality Smart Classroom Group |
Primary outcome
Change in Core ADHD Symptoms Measured by the ADHD Rating Scale (ADHD-RS)
Time frame: Baseline and at the end of the 12-week intervention period
Core symptoms of attention-deficit/hyperactivity disorder (ADHD) were assessed using the ADHD Rating Scale (ADHD-RS), which includes subscales for inattention and hyperactivity/impulsivity. Higher scores indicate greater symptom severity. The scale was completed by trained evaluators based on standardized assessment procedures.
3 secondary outcomes
Change in Executive Function Measured by the Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
Change in Inattention Symptoms Measured by the ADHD Rating Scale (ADHD-RS) Inattention Subscale
Time frame: Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
Change in Hyperactivity/Impulsivity Symptoms Measured by the ADHD Rating Scale (ADHD-RS) Hyperactivity/Impulsivity Subscale
Time frame: Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
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 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ning Li, PhD principal investigator
Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Assisted Teaching and Virtual Reality-Based Smart Classroom Teaching in people with Attention Deficit Hyperactivity Disorder, run by Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province at 1 site in China.
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 7 inclusion and 9 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 6 Feb 2026. 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 China. 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. 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?
Change in Core ADHD Symptoms Measured by the ADHD Rating Scale (ADHD-RS) (time frame: Baseline and at the end of the 12-week intervention period). 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 6 Feb 2026.