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A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication group | Active Comparator | The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks. |
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| Digital therapeutics group | Experimental | The digital therapeutics group will complete 30 training sessions within 8 weeks. |
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| Combination group | Experimental | The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concerta | Drug | Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Swanson, Nolan, and Pelham IV Rating Scale | The Swanson, Nolan, and Pelham IV Rating Scales (SNAP-IV) will be completed by parents to assess the severity of ADHD symptoms. The values range from 0 to 3, with lower scores indicating a better outcome. | Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD | The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ADHD will be used to assess the number of core symptoms. There are a total of 18 core symptoms, with fewer symptoms indicating a better outcome. | Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanhao Cai, MBBS | Contact | 15001969690 | 15552283399@163.com | |
| Lei Lei, MD | Contact | 13916072205 | doctorlei_lei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Lei, MD | Department of Pediatric, Changhai Hospital, Naval Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzheng Hospital, Naval Medical University | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42152117 | Derived | Zhao X, Cai Y, Zhang X, Xu T, Qian Y, Hao W, Wang Y, Yuan J, Cai T, Zhou L, Li H, Lei L. Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial. Trials. 2026 May 18. doi: 10.1186/s13063-026-09775-4. Online ahead of print. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Digital therapeutics | Device | 30 sessions of digital therapeutics, each lasting 30 minutes, will be conducted with a frequency of once every 1-2 days over an 8-week period. |
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| Questionnaire-Children with Difficulties | The Questionnaire-Children with Difficulties (QCD) will be completed by parents to assess the social abilities of participants. The total questionnaire score is 57, and a score below 30 suggests impaired functioning. | Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32) |
| Behavior Rating Inventory of Executive Function | The Behavior Rating Inventory of Executive Function (BRIEF) will be completed by parents to assess changes in executive function. The normal standards for scores vary by age, with lower scores indicating a better outcome. | Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32) |
| Continuous Performance Test | A newly designed Continuous Performance Test (CPT) will be administered to participants by investigators, with higher accuracy rates indicating a better outcome. | Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32) |
| Digital Cancellation Test | The Digit Cancellation Test (DCT) will be administered to participants by investigators, with higher scores indicating a better outcome. | Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32) |
| Changhai Hospital, Naval Medical University | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |