NCT07392463

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 25, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

ADHDArtificial IntelligenceVirtual RealityDigital EducationExecutive FunctionChildren and AdolescentsRandomized Controlled TrialNon-Pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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

    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

    Baseline, at the end of the 12-week intervention period, and at the 3-month post-intervention follow-up

Study Arms (2)

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.

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.

Behavioral: Virtual Reality-Based Smart Classroom Teaching

Interventions

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.

AI-Assisted Teaching Group

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.

Virtual Reality Smart Classroom Group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongxinkang New Traditional Chinese Medicine Hospital, Tongren

Tongren, Guizhou, 554300, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ning Li, PhD

    Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the digital teaching interventions, participants and intervention providers were not blinded to group assignment. Outcome assessors were blinded to treatment allocation throughout data collection and evaluation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 6, 2026

Study Start

January 1, 2024

Primary Completion

January 31, 2025

Study Completion

September 30, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations