The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
ADHD intervention
The early integrated intervention for ADHD
Intervention: The early integrated intervention for ADHD (Behavioral)
GDD intervention
The early integrated intervention for GDD
Intervention: The early integrated intervention for GDD (Behavioral)
GDD non-intervention
Community intervention for GDD
Intervention: Community intervention for GDD (Behavioral)
ASD intervention
The early integrated intervention for ASD
Intervention: The early integrated intervention for ASD (Behavioral)
ASD non-intervention
Community intervention for ASD
Intervention: community intervention for ASD (Behavioral)
ADHD non-intervention
Community intervention for ADHD
Intervention: community intervention for ADHD (Behavioral)
Outcomes
Primary Outcomes
Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
Time Frame: 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.
The Conners Early Childhood (Conners EC) aids in the early identification of behavioral, social, and emotional problems. It consists of 110 items. According to the 110 items of Conners EC, parents score children's behavioral frequency based on daily observations. The higher the score is, the more serious behavioral problems the children have. This is a repeate measurement
Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD
Time Frame: from enrollment to end of intervention (2 years). The DQ will be measured at the following time point: enrollment, 1 year, 2 years.
Griffiths Development Scales-Chinese version consists of 5 subscales, which are locomotor scale, personal-social scale, eye\& hand coordination scale, hearing\& language scale. Each subscale has a development quotient. The developmental ages (DA) are referred from the norms and developmental quotients (DQ) are calculated by DA/CA (chronological age)\*100. DQ for subscales have a mean of 100 (SD: 15). Higher DQ represent a better outcome. This is a repeate measurement
Secondary Outcomes
- 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(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.)
- Change from baseline intelligence quotient (IQ) in the Wechsler Intelligence Scale at 1 year, 2 years for ADHD(from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years)