- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07392463
Artificial Intelligence Versus Virtual Reality Teaching for Children and Adolescents With ADHD
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guizhou
-
Tongren, Guizhou, China, 554300
- Hongxinkang New Traditional Chinese Medicine Hospital, Tongren
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-Assisted Teaching Group
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.
|
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.
|
|
Experimental: Virtual Reality Smart Classroom Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and at the end of the 12-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ning Li, PhD, Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THKX-ADHD-AI-VR-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Hyperactivity Disorder
-
King's College LondonActive, not recruitingAttention-Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder SymptomsUnited Kingdom
-
Cingulate TherapeuticsSuspendedPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
-
Cingulate TherapeuticsPremier Research Group plcCompletedADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Qbtech ABEnrolling by invitationAttention Deficit Disorder With Hyperactivity (ADHD) | Attention Deficit Disorder (ADD)United States
-
Universidade do Sul de Santa CatarinaAssociação Brasileira de Cannabis MedicinalRecruitingAttention-Deficit/Hyperactivity Disorder (ADHD)Brazil
-
Nanjing Medical UniversityRecruitingAdult Attention Deficit Hyperactivity DisorderChina
-
Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia and other collaboratorsNot yet recruitingAttention-Deficit/Hyperactivity Disorder (ADHD)United States
-
Otsuka Pharmaceutical Development & Commercialization...CompletedAttention Deficit Disorder With HyperactivityUnited States
-
University of Texas at AustinRecruitingAttention Deficit Hyperactivity DisorderUnited States
Clinical Trials on Artificial Intelligence-Assisted Teaching
-
Renmin Hospital of Wuhan UniversityNot yet recruitingEndoscopic UltrasoundChina
-
Javier Santos FernándezCompletedColorectal Neoplasms | Colorectal Cancer | Adenoma Colon PolypSpain
-
Ovation FertilityIVF 2.0 LimitedRecruiting
-
The University of Hong KongUniversity Grants Committee, Hong KongCompleted
-
Chinese Academy of Medical Sciences, Fuwai HospitalUnknownSleep Apnea | Coronary Heart Disease | Artificial IntelligenceChina
-
Seattle Children's HospitalFlorida International UniversityCompletedAttention Deficit Hyperactivity DisorderUnited States
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
Shenyang Northern HospitalRecruitingSTEMI - ST Elevation Myocardial InfarctionChina
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingInflammatory Bowel Diseases | Colonoscopy | MicrobiotaTurkey
-
Mansoura UniversityActive, not recruitingNursing Students | Electronic Fetal Monitoring | Artificial Intelligence (AI)Egypt