Neurodevelopmental Disorders
Conditions
Interventions
Experimental Group:Zhihuisu Supplementation Protocol:Duration: 12 weeks
Age 1-3 years: One sachet of *Zhihuisu-1* administered orally each morning
Age 4-10 years: Two sachets of *Zhihuisu-2* administe
Control Group:Cognitive Behavioral Therapy (CBT) Intervention :Duration: 12 weeks
Frequency: Once-weekly 45-minute sessions"
Sponsors
Guangzhou Women and Children's Medical Center
Eligibility
Sex/Gender
All
Age
1 Years to 10 Years
Inclusion criteria
Inclusion criteria: (1) Aged 1-10 years old, meeting the diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for neurodevelopmental disorders; (2) Sleep-related problems (CSHQ >=42, sleep onset latency: >30 minutes or number of nocturnal awakenings >=3 times/night); (3) Legal guardians or legal representatives signed written informed consents and promised to complete the 3-month follow-up and the whole course of the intervention. Written informed consent was obtained from children 8 years of age or older.
Exclusion criteria
Exclusion criteria: (1) Complicated with severe organic diseases (such as congenital heart disease, hepatic and renal insufficiency); (2) Use of psychotropic drugs (such as atomoxetine, melatonin, treserin, etc.) that may affect sleep or mood function within the past 3 months, or participating in other similar clinical trials; (3) Known to be allergic to the core components of Zhibitrin (ferulic acid, PS, Angelica dahurica extract) or have a history of severe food allergy; (4) Children were unable to cooperate with intervention and evaluation due to behavioral problems (such as aggressive behavior and severe self-injury).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children’s Sleep Habits Questionnaire;Brief Infant Sleep Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant Behavior Questionnaire;(Conners' Parent Rating Scale - Revised,CPRS-R);PedsQL; | — |
Countries
China
Contacts
Public ContactKaishou Xu
Guangzhou Women and Children's Medical Center, Affiliated with Guangzhou Medical University
Outcome results
None listed