Attention Deficit Hyperactivity Disorder (ADHD), Tic Disorder (TD), and Tic Disorder (TD) coexist with ADHD
Conditions
Interventions
treatment group:Children aged 6-12 diagnosed with ADHD were intervened by digital therapy and drug therapy.
treatment group:Children aged 6-12 diagnosed as TD with ADHD comorbidity were intervened by digital therapy and drug therapy.
treatment group:Children aged 6-12 diagnosed with TD and without other comorbidities were intervened by digital therapy and drug therapy.
treatment group:For children aged 6-12 who are diagnosed with TD, with or without other comorbidities, only digital therapy is used for intervention.
Sponsors
Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria for subjects in the Attention Deficit Hyperactivity Disorder (ADHD) subprotocol are: (1) Meet the diagnostic criteria for ADHD in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-V), attention-deficit or mixed patients; (2) 6 years old = 80; (4) The first- and second-line standard treatment regimens were stably followed for 30 days or more before enrollment, and the original regimen and dose were maintained during the trial; (5) Comply with the study plan to complete treatment testing (6) Patients and/or their guardians agree to participate in this study and sign the informed consent form voluntarily, and subjects aged 8 years and above should also sign the informed consent form for children. The inclusion criteria for the TD sub-protocol subjects are: 1. Patients with chronic tic and Tourt syndrome with a course of more than one year in accordance with the diagnostic criteria of the American Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for tic disorders; 2. 6 to 12 years old, gender is not limited; 3. Children's Wechsler Intelligence Scale >= 80; 4. The first- and second-line standard treatment regimens were stably followed for 30 days or more before enrollment, and the original regimen and 5. Comply with the relevant requirements of the research plan to complete treatment, testing and other relevant requirements; 6. Patients and/or their guardians agree to participate in this study and voluntarily sign the informed consent form, and subjects aged 8 and above should also sign Children's Informed Consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects in the Attention Deficit Hyperactivity Disorder (ADHD) subprotocol were: (1) Suffering from neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy; (2) Suffering from serious mental diseases such as schizophrenia; (3) Hearing impairment causes similar symptoms of attention deficit-hyperactivity disorder in children (4) Those who are still ineffective after two different types of ADHD drug systemic treatment; (5) Those who cannot use software normally, such as color blindness; (6) Those who have past or current game addiction; (7) Those who have recently (past) Within 6 months) Suspected history of drug abuse or dependence; (8) Movement states reported by family members or observed by investigators that hinder intervention (such as physical deformity or dysfunction of hands/arms, use of prosthetic limbs, etc.); (9) Ever have Suicidal ideation or those with severe suicidal impulses judged by the investigator; (10) Those who are participating in other clinical trials within 1 month and have not yet been enrolled; (11) Those who are considered unsuitable for enrollment by the investigator. The exclusion criteria for subjects in the TD sub-protocol are: 1. History of changing tic drugs (starting or stopping) in the past 3 months, and the current treatment effect is unstable, and the observer needs to continue to be adjusted; 2. The past 6 months Those who have experienced 2 or more drug types adjustment plans within the past, and the current treatment effect has not yet reached the expected; 3. Those who suffer from other comorbidities other than those specified in the group, which affect the implementation of the treatment plan and the judgment of the efficacy results; 4. Those who cannot use the software normally, such as color blindness, limb dysfunction or difficulty in maintaining posture; 5. Past or current game addicts; 6. A history of suspected drug abuse or dependence recently (within the past 6 months); 7. Suicidal ideation or those with severe suicidal impulses judged by the investigator; 8. Those who are participating in other clinical trials within 1 month and have not yet been included in the group; 9. Those who are considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 4 weeks of intervention for ADHD children, the response rate of 18 SNAP-IV- Parent Scale was higher than that of baseline treatment.;Children with TD or TD with ADHD were treated with digital therapy for 12 weeks, and compared with the baseline, the decrease rate of YGTSS- TTSS was evaluated.; | — |
Secondary
| Measure | Time frame |
|---|---|
| TOVA-ACS data of ADHD children improved from baseline after 4 weeks of intervention.;After 4 weeks of intervention for ADHD children, the evaluation values of 18 SNAP-IV- Parent Scale were improved compared with the baseline values.;Acceptance rate of digital therapy for ADHD children;Compliance rate of ADHD children with digital therapy;The clinical efficacy-overall improvement (CGI-GI) score at 4 weeks, 8 weeks and 12 weeks after digital therapy was compared with the baseline improvement value.;Clinical Efficacy-Severity (CGI-SI) scores at 4 weeks, 8 weeks and 12 weeks after digital therapy were improved compared with baseline values.;The clinical efficacy-efficacy index (CGI-EI) scores at 4 weeks, 8 weeks and 12 weeks after digital therapy were improved compared with the baseline values.;Spence children's anxiety scale improved compared with baseline after 4, 8 and 12 weeks of digital therapy.;The evaluation values of Child Health Utility 9D (CHU9D) scale after 4 weeks, 8 weeks and 12 weeks of digital therapy were improved compared with the baseline values.;The total twitch score of Yale Global Tic Severity Scale (YGTSS- TTSS) was improved from baseline after 4 weeks and 8 weeks of digital therapy.;The evaluation value of Hamilton anxiety rating scale (HAMA) of parents of the subjects after 12 weeks of digital therapy was improved compared with the baseline value.; | — |
Countries
China
Contacts
Public ContactSun Dan
Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology
Outcome results
None listed