Clinical trial NCT03847402: The Early Integrated Intervention for Child Brain-developmental Disorders in China
Official title: The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Developmental Diseases
Autism Spectrum Disorder
Global Developmental Delay
Attention Deficit-Hyperactivity Disorder
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: National Key Research and Development Program of China
First posted: 2019-02-20
Enrollment: 900
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is focused on developing the early integrated intervention for child brain-developmental disorders, including globe developmental delay (GDD), autism spectrum disorder (ASD), and attention deficit-hyperactivity disorder (ADHD), in China.

Detailed description: The early integrated intervention of GDD and ASD is developed by Children's Hospital of Fudan University.

The early integrated intervention of ADHD is developed by Nanjing Brain Hospital.

Eligibility criteria: Inclusion Criteria:

* GDD: IQ\<70, in more than 2 areas of development;
* ASD: Diagnose must meet the criteria of DSM-V;
* ADHD: Diagnose must meet the criteria of DSM-V, and IQ\>70 tested by Wechsler Intelligence Scale；
* At least one of the parents could take part in the whole courses, and do the training at home.

Exclusion Criteria:

* Physical disability, visual or hearing loss;
* Combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;

Primary outcomes:
measure: Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD
timeFrame: from enrollment to end of intervention (2 years). The DQ will be measured at the following time point: enrollment, 1 year, 2 years.
measure: Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
timeFrame: from enrollment to end of intervention (2 years). The score of Conners EC will be measured at the following time point: enrollment, 1 year, 2 years.
Secondary outcomes:
measure: Change from baseline score of the Communication and Symbolic Behavior Scales Developmental Profile-Infant Toddler Checklist（CSBS-DP-ITC）at 1 year, 2 years for ASD
timeFrame: from enrollment to end of intervention (2 years). The score of CSBS-DP-ITC will be measured at the following time point: enrollment, 1 year, 2 years.
measure: Change from baseline intelligence quotient (IQ) in the Wechsler Intelligence Scale at 1 year, 2 years for ADHD
timeFrame: from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiu Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: