Attention Deficit Hyperactivity Disorder (ADHD)NCT07552909
A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children
A study of Attention Deficit Hyperactivity Disorder (ADHD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Explore the interventional effects of neurofeedback games on school-aged children with mild to moderate ADHD, with the aim of providing evidence-based new methods for intervening in the core symptoms of ADHD in children. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 years 0 months to 11 years 11 months
- Clinical diagnosis of ADHD made by a child psychiatrist at the attending level or above
- Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85
- Children who have been diagnosed with ADHD but have not received any intervention (newly diagnosed within the last month or not having taken medication for at least 4 weeks)
- Informed consent must be obtained from the patient/guardian and from participants
Who cannot join
- Auditory or visual illness or disorder
- Inability to use software (e.g., color blindness, impaired hand function, or disability)
- Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders
- Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders
- Attention deficit disorder caused by organic neurological diseases or other organic diseases
- Previous regular ADHD medication use as prescribed by a doctor, but without efficacy
Show all 9Show fewer
- Past or present gaming addiction
- Previous neurofeedback-like "brain control game" interventions
- Previous physical therapy such as magnetic stimulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Weiping Xia
Shanghai, Shanghai Municipality, 200092
Weiping Xia, PhD, +86021-25076686, summertree20@163.com
summertree20@163.com
About this study
Official title: Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games
Explore the interventional effects of neurofeedback games on school-aged children with mild to moderate ADHD, with the aim of providing evidence-based new methods for intervening in the core symptoms of ADHD in children.
Read the detailed description
- Research Title A Randomized Controlled Study on the Efficacy of Home-Based Digital Therapy with Brain-Controlled Games for School-Aged Children with Attention Deficit Hyperactivity Disorder.
- Research Objective To explore the efficacy of brain-controlled games as an intervention for school-aged children with mild to moderate ADHD, with the aim of providing a new evidence-based method to intervene in the core symptoms of ADHD.
- Study Design Randomized Controlled Study.
- Total Cases
- Case Selection Inclusion Criteria: Children aged 7 years, 0 months to 11 years, 11 months who are diagnosed by a physician with at least the rank of attending physician in pediatric psychiatry as meeting the diagnostic criteria for ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), have a full-scale Wechsler IQ higher than 85, and are outpatient children with ADHD who have not received any intervention (newly diagnosed within the last month or have not taken medication for at least 4 weeks). Informed consent will be obtained from the patient/guardian and from participants aged 8 years and older.
- Exclusion Criteria Exclusion criteria include:
- Auditory or visual diseases or disorders.
- Inability to use the software, such as color blindness, or hand function defects or disabilities.
- Comorbidities with other neurodevelopmental disorders such as oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, Tourette's syndrome, etc.
- Patients with other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders.
- Attention deficit disorder caused by organic diseases of the nervous system or other organic diseases.
- Previous history of ineffective regular ADHD medication as prescribed by a doctor.
- Past or present game addiction.
- Previous similar brain-controlled game interventions like Neurotest.
- Previous physical therapy such as magnetic stimulation.
- Treatment Protocol Home-based digital therapy with ADHD brain-controlled games.
- Efficacy Assessment Primary Outcome Measure: ADHD SNAP-IV subscale scores (Inattention/Hyperactivity-Impulsivity). Secondary Outcome Measure: Executive Function (BRIEF) questionnaire scores.
- Statistical Methods
The differences in evaluation results between the intervention group and the control group will be analyzed using a repeated measures analysis of variance from a general linear model. Missing data will be handled using the Last Observation Carried Forward (LOCF) method. The study will control for inter-group bias through measures such as random assignment, consistent training of evaluators, and blind evaluation where the evaluators are unaware of the subjects' treatment status.
- Being tested
- Home-based digital therapy with brain-controlled games
- Keywords
- Attention deficit hyperactivity disorder, Randomized Controlled, Digital Brain-controlled
- 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.
Home-based digital therapy with brain-controlled gamesDevice
Home-based brain-controlled training for children with ADHD is completed in a home environment. The training session lasts for 30 minutes daily, with a total of 30 sessions to be completed within a 2-month period. All training frequency and duration are presented in a quantifiable format.
The training process incorporates engaging game elements. AI technology is used to provide real-time monitoring and difficulty adjustments, ensuring that each child's training intensity and content are personalized and optimized based on their individual needs.
Eye-tracking technology is integrated into the game training to further enhance the training effects on visual attention and cognitive control, making the training more comprehensive and multi-faceted.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Control group: Participants will receive standard clinical care, with treatment strategies determined by the clinician based on their clinical experience, professional knowledge, and the specific condition of the school-aged child with ADHD. This includes outpatient guidance and ADHD health education from the doctor. No study-specific interventions will be applied during this period, and participants will be followed up at predetermined time points. |
| Intervention group | Experimental | For children in the intervention group, the entire training process will be completed at home. Each training session will last for 30 minutes, and a total of 30 sessions will be completed within 2 months of enrollment. All training frequency and duration will be presented in a quantifiable format. Receives: Device: Home-based digital therapy with brain-controlled games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention
Assess using the Inattention subscale scores from the parent version of the Swanson, Nolan, and Pelham-IV (SNAP-IV) 47-item Rating Scale. The Inattention subscale consists of the first 9 items of the parent version of the 47-item SNAP-IV scale, directly corresponding to the DSM-5 diagnostic criteria for inattentive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much). The subscale score is calculated as the mean of items 1-9 (range 0-3). Higher scores indicate greater symptom severity. Based on established clinical norms (Swanson, 2001), a mean score of ≥ 1.67 is defined as the threshold for a "positive" symptomatic response (clinical significance) for Inattention. Previous studies have demonstrated that this subscale possesses exceptional psychometric properties, with internal consistency (Cronbach's α) reported as high as 0.95 in recent clinical evaluations (Enemuo et al., 2022; Hall et al., 2020).
Measured: The first week after the intervention
Hyperactivity-Impulsivity
Assess using the Hyperactivity-Impulsivity subscale scores from the parent version of the SNAP-IV questionnaire. The Hyperactivity-Impulsivity subscale consists of items 10-18 of the parent version of the 47-item SNAP-IV scale, corresponding to the DSM-5 criteria for hyperactive and impulsive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much).The subscale score is calculated as the mean of items 10-18 (range 0-3). Higher scores reflect increased severity of hyperactivity and impulsivity. According to standardized norms, a mean score of ≥ 1.50 is used as the cut-off point to determine a "positive" symptomatic status (clinical significance) for Hyperactivity-Impulsivity. Extensive psychometric evaluations have reported exceptional reliability for this subscale, with a Cronbach's α coefficient reported as high as 0.92 to 0.94 in clinical samples (Bussing et al., 2008; Hall et al., 2020).
Measured: The first week after the intervention
Secondary outcomes (1)
executive function
Executive function will be assessed using the Behavior Rating Inventory of Executive Function (BRIEF; Gioia et al., 2000). The Parent-Report form consists of 86 items rated on a 3-point Likert scale(1 = Never, 2 = Sometimes, 3 = Often). The inventory yields two primary indexes: the Behavioral Regulation Index (BRI: Inhibit, Shift, Emotional Control) and the Metacognition Index (MI: Working Memory, Plan, Organize, Monitor), which combine into the Global Executive Composite (GEC).
Raw scores will be converted into standardized T-scores (M=50,SD=10) using age- and gender-appropriate norms. Higher T-scores reflect greater dysfunction, with T≥65 indicating clinical significance. The BRIEF is a well-validated instrument; according to the technical manual and prior clinical studies (Gioia et al., 2000; Donders et al., 2002), the Cronbach's α for the GEC exceeds 0.90, ensuring robust reliability for evaluating intervention efficacy.
Measured: The first week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start24 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weiping Xia, PhD, Study director, Department of Clinical Psychology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552909
- Sponsor's protocol ID
- XH-25-007
- Status last verified
- Sep 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games
- ClinicalTrials.gov ID
- NCT07552909
- Acronym / sponsor ID
- XH-25-007
- Keywords
- Attention deficit hyperactivity disorder, Randomized Controlled, Digital Brain-controlled
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 24 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Apr 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.
Explore the interventional effects of neurofeedback games on school-aged children with mild to moderate ADHD, with the aim of providing evidence-based new methods for intervening in the core symptoms of ADHD in children.
Detailed description
- Research Title A Randomized Controlled Study on the Efficacy of Home-Based Digital Therapy with Brain-Controlled Games for School-Aged Children with Attention Deficit Hyperactivity Disorder.
- Research Objective To explore the efficacy of brain-controlled games as an intervention for school-aged children with mild to moderate ADHD, with the aim of providing a new evidence-based method to intervene in the core symptoms of ADHD.
- Study Design Randomized Controlled Study.
- Total Cases
- Case Selection Inclusion Criteria: Children aged 7 years, 0 months to 11 years, 11 months who are diagnosed by a physician with at least the rank of attending physician in pediatric psychiatry as meeting the diagnostic criteria for ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), have a full-scale Wechsler IQ higher than 85, and are outpatient children with ADHD who have not received any intervention (newly diagnosed within the last month or have not taken medication for at least 4 weeks). Informed consent will be obtained from the patient/guardian and from participants aged 8 years and older.
- Exclusion Criteria Exclusion criteria include:
- Auditory or visual diseases or disorders.
- Inability to use the software, such as color blindness, or hand function defects or disabilities.
- Comorbidities with other neurodevelopmental disorders such as oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, Tourette's syndrome, etc.
- Patients with other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders.
- Attention deficit disorder caused by organic diseases of the nervous system or other organic diseases.
- Previous history of ineffective regular ADHD medication as prescribed by a doctor.
- Past or present game addiction.
- Previous similar brain-controlled game interventions like Neurotest.
- Previous physical therapy such as magnetic stimulation.
- Treatment Protocol Home-based digital therapy with ADHD brain-controlled games.
- Efficacy Assessment Primary Outcome Measure: ADHD SNAP-IV subscale scores (Inattention/Hyperactivity-Impulsivity). Secondary Outcome Measure: Executive Function (BRIEF) questionnaire scores.
- Statistical Methods
The differences in evaluation results between the intervention group and the control group will be analyzed using a repeated measures analysis of variance from a general linear model. Missing data will be handled using the Last Observation Carried Forward (LOCF) method. The study will control for inter-group bias through measures such as random assignment, consistent training of evaluators, and blind evaluation where the evaluators are unaware of the subjects' treatment status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Control group: Participants will receive standard clinical care, with treatment strategies determined by the clinician based on their clinical experience, professional knowledge, and the specific condition of the school-aged child with ADHD. This includes outpatient guidance and ADHD health education from the doctor. No study-specific interventions will be applied during this period, and participants will be followed up at predetermined time points. |
| Intervention group | Experimental | Device: Home-based digital therapy with brain-controlled gamesFor children in the intervention group, the entire training process will be completed at home. Each training session will last for 30 minutes, and a total of 30 sessions will be completed within 2 months of enrollment. All training frequency and duration will be presented in a quantifiable format. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 7 years 0 months to 11 years 11 months
- Clinical diagnosis of ADHD made by a child psychiatrist at the attending level or above
- Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85
- Children who have been diagnosed with ADHD but have not received any intervention (newly diagnosed within the last month or not having taken medication for at least 4 weeks)
- Informed consent must be obtained from the patient/guardian and from participants
Key exclusion criteria (9 listed)
- Auditory or visual illness or disorder
- Inability to use software (e.g., color blindness, impaired hand function, or disability)
- Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders
- Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders
- Attention deficit disorder caused by organic neurological diseases or other organic diseases
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 |
|---|---|---|
| Home-based digital therapy with brain-controlled gamesHome-based brain-controlled training for children with ADHD is completed in a home environment. The training session lasts for 30 minutes daily, with a total of 30 sessions to be completed within a 2-month period. All training frequency and duration are presented in a quantifiable format. The training process incorporates engaging game elements. AI technology is used to provide real-time monitoring and difficulty adjustments, ensuring that each child's training intensity and content are personalized and optimized based on their individual needs. Eye-tracking technology is integrated into the game training to further enhance the training effects on visual attention and cognitive control, making the training more comprehensive and multi-faceted. | Device | Intervention group |
Primary outcome
Inattention
Time frame: The first week after the intervention
Assess using the Inattention subscale scores from the parent version of the Swanson, Nolan, and Pelham-IV (SNAP-IV) 47-item Rating Scale. The Inattention subscale consists of the first 9 items of the parent version of the 47-item SNAP-IV scale, directly corresponding to the DSM-5 diagnostic criteria for inattentive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much). The subscale score is calculated as the mean of items 1-9 (range 0-3). Higher scores indicate greater symptom severity. Based on established clinical norms (Swanson, 2001), a mean score of ≥ 1.67 is defined as the threshold for a "positive" symptomatic response (clinical significance) for Inattention. Previous studies have demonstrated that this subscale possesses exceptional psychometric properties, with internal consistency (Cronbach's α) reported as high as 0.95 in recent clinical evaluations (Enemuo et al., 2022; Hall et al., 2020).
Hyperactivity-Impulsivity
Time frame: The first week after the intervention
Assess using the Hyperactivity-Impulsivity subscale scores from the parent version of the SNAP-IV questionnaire. The Hyperactivity-Impulsivity subscale consists of items 10-18 of the parent version of the 47-item SNAP-IV scale, corresponding to the DSM-5 criteria for hyperactive and impulsive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much).The subscale score is calculated as the mean of items 10-18 (range 0-3). Higher scores reflect increased severity of hyperactivity and impulsivity. According to standardized norms, a mean score of ≥ 1.50 is used as the cut-off point to determine a "positive" symptomatic status (clinical significance) for Hyperactivity-Impulsivity. Extensive psychometric evaluations have reported exceptional reliability for this subscale, with a Cronbach's α coefficient reported as high as 0.92 to 0.94 in clinical samples (Bussing et al., 2008; Hall et al., 2020).
1 secondary outcome
executive function
Time frame: The first week after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Weiping Xia, PhD study director
Department of Clinical Psychology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Attention Deficit Hyperactivity Disorder (ADHD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 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: looking for participants now, as of the sponsor's last update on 8 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiping Xia, PhD (+8613761137709, summertree20@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inattention (time frame: The first week after the intervention). The study lists 2 primary outcomes in all. 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 8 Sep 2026.