Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), Language Disorder, Intellectual Developmental Disorder (IDD), and Developmental Learning Disorder are all neurodevelopmental disorders.
Conditions
Interventions
Zhihuisu group:Use Zhihuisu
Sponsors
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Age 1-10 years, meeting the diagnostic criteria for neurodevelopmental disorders in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 2. The child has sleep-related issues (CSHQ >=42 points [31], sleep latency: >30 minutes or nocturnal awakenings >=3 times/night); 3. Guardians or legal representatives must sign a written informed consent form, committing to completing the 3-month follow-up and participating throughout the intervention process; 4. Written informed consent is required for children aged >=8 years.
Exclusion criteria
Exclusion criteria: 1.The child has a serious organic disease (such as congenital heart disease, liver or kidney dysfunction); 2. Has used psychiatric drugs that may affect sleep or emotional function within the past 3 months (such as atomoxetine, melatonin, escitalopram, etc.), or is participating in other similar clinical trials; 3. Has known allergies to the core components of Zhihui Su (ferulic acid, PS, Angelica extract), or has a history of severe food allergies; 4.The child cannot cooperate with intervention and assessment due to behavioral problems (such as aggressive behavior, severe self-harm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Infant Sleep Questionnaire;Children’s Sleep Habits Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant Behavior Questionnaire-Revised;Pediatric Quality of Life Inventory;Emotion Regulation Checklist, ERC;Adverse Event Record ; | — |
Countries
China
Contacts
Public ContactXu Kaishou
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Outcome results
None listed