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Development and Clinical Validation of ADHD Digital Therapy Based on Process Evolution

Development and Clinical Validation of ADHD Digital Therapy Based on Process Evolution

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100097
Enrollment
Unknown
Registered
2025-04-02
Start date
2024-03-14
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit and hyperactivity disorder

Interventions

intervention group:ADHD digital therapy training
control group:Complete the Chinese character puzzle task

Sponsors

Affiliated Mental Health Center & Hangzhou Seventh People's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age between 6 and 12 years old (including 6 and 12 years old), male or female, body weight >=20kg; 2. ADHD was diagnosed by an attending pediatrician or above according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-V) criteria; 3. eyes all visible objects; 4. normal IQ (raven reasoning test correction IQ of 80 or higher), to be able to understand and participate in the study of task; 5. parents of ADHD rating scale version 4 (ADHD RS - IV - the Parent) boy score 25 points or more, a girl 22 points or more; 6. Baseline TOVA ACS score <0; 7. The legal guardian signed the informed consent before the trial;

Exclusion criteria

Exclusion criteria: 1. patients with serious medical diseases such as heart, liver, kidney, glaucoma and secretion; Or have epilepsy, mental retardation and other neurological mental illness; 2. laboratory abnormalities and laboratory tests that are considered clinically significant by the investigators; 3. in the first 3 months participated in other clinical trials; 4. a history of game addiction; 5. receiving systematic psychotherapy, family behavioral intervention, or other non-pharmacological interventions for ADHD; 6. in group 2 weeks before used monoamine oxidase inhibitors (MAOI), antipsychotics, antidepressants and mood stabilizers; 7. with can significantly enhance the activity of the sympathetic system body disease (such as secretion of catecholamine nerve tumors), or a day to sympathetic nerve activity of drugs (such as comfortable and gasp the spirit, inhaled aerosol, false comospore rue alkali); 8. researchers believe there are other common disease or are taking the drug may interfere with the efficacy of cognitive training; 9. In the opinion of the investigator, the subject and/or the parent or guardian of the subject are not able to fully understand the study or follow the requirements of the study.

Design outcomes

Primary

MeasureTime frame
continuous performance test on visual and auditory;Raven's Standard Progressive Matrices;ADHD Parental Rating Scale 4th Edition;CCBS,Cornai's Child Behavior Scale;WFIRS,Weiss's Quantitative Scale of Functional Defects;BRIEF-P,Behavior Rating Scale for Executive Functioning-Parent Questionnaire;CBCL,Child Behavior Scale;High-precision EEG data;Functional near-infrared data;

Countries

China

Contacts

Public ContactLi Xiaojing

Affiliated Mental Health Center & Hangzhou Seventh People's Hospital, Zhejiang University School of Medicine

Xiaojing_Li@zju.edu.cn+86 173 6012 5230

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026