Attention deficit and hyperactivity disorder
Conditions
Interventions
Focus Run group:Participants will use Focus Run for treatment, 25 minutes per day, 5 days per week, over an intervention period of 4 to 6 weeks, with a total duration of no less than 500 minutes. The
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Age: 4 years old (inclusive) to 14 years old (exclusive), gender is not limited; 2. Diagnosis of ADHD: The diagnosis of ADHD is confirmed by a specialist clinician through clinical interviews according to the Diagnostic and Statistical Manual of Mental Health-Fifth Edition (DSM-5) of the United States. 3. ADHD Treatment: Newly diagnosed ADHD, untreated (both pharmacological and non-pharmacological); Previous history of ADHD drug treatment, and complete discontinuation of medication for 4 weeks or more before baseline testing; Ongoing non-pharmacological treatment for ADHD, who have maintained the current treatment regimen for 4 weeks or more, and can continue to maintain the content, frequency and intensity of treatment during the clinical study. 4. IQ: Within 6 months prior to baseline screening, the total IQ of the Wechsler Intelligence Scale was > 80; 4 years old (inclusive) to 6 years old, measured using the Wechsler Intelligence Scale for Young Children Fourth Edition (WPPSI-IV); From 6 years old (inclusive) to 14 years old, the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) was used. 5. Subjects are willing and able to comply with the treatment methods specified in this protocol during the study, and cooperate with the investigator's evaluation work; 6. The subject voluntarily and guardian agrees and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe neurodevelopmental disorder and/or psychiatric disorder with significant comorbid symptoms of the subject: Including but not limited to: severe anxiety, depression, phobia disorder, severe obsessive-compulsive disorder, schizophrenia, bipolar and related disorders, autism spectrum disorder, conduct disorder, etc.; Other symptomatic manifestations that, in the opinion of the investigator, may confound the study data; For subjects with comorbid developmental learning disabilities, the investigator is required to evaluate that they can cooperate with the treatment and evaluation specified in this protocol before they can be enrolled. 2. The subject has used or is using other psychotropic drugs that may confound the study data, as assessed by the investigator; 3. Subject has a history of photosensitive epilepsy, and/or motor tics and vocal tics (including but not limited to Tourette syndrome); 4. Subject has a physical impairment that may prevent him or her from cooperating to complete treatment: Physical disorders: movement disorders of arms and hands, etc.; Vision and hearing impairment: color blindness, uncorrectable vision and hearing abnormalities, etc.; Physical impairment that, in the opinion of other investigators, may result in the subject's inability to cooperate with treatment. 5. The subject has other medical conditions that may cause him or her to be unable to cooperate with the completion of the trial or to confuse the study data, which will be evaluated by the investigator; 6. Subjects have participated in other clinical studies within 3 months prior to baseline screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The SNAP-IV scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) score;Behavior Rating Inventory of Executive Function (BRIEF) score;Functional Near-Infrared Spectroscopy (fNIRS);Cancellation Test Score;Continuous Performance Test Score;Compliance (percentage of the total prescribed treatment duration completed); | — |
Countries
China
Contacts
Public ContactWang Yu
Shanghai Children's Hospital
Outcome results
None listed