The Early Integrated Intervention for Child Brain-developmental Disorders in China
The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China
1 other identifier
interventional
900
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2018
CompletedFirst Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedJanuary 11, 2022
January 1, 2021
3 years
February 11, 2019
January 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD
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
from enrollment to end of intervention (2 years). The DQ will be measured at the following time point: enrollment, 1 year, 2 years.
Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
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
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 (2)
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
Study Arms (6)
GDD intervention
EXPERIMENTALThe early integrated intervention for GDD
GDD non-intervention
ACTIVE COMPARATORCommunity intervention for GDD
ASD intervention
EXPERIMENTALThe early integrated intervention for ASD
ASD non-intervention
ACTIVE COMPARATORCommunity intervention for ASD
ADHD intervention
EXPERIMENTALThe early integrated intervention for ADHD
ADHD non-intervention
ACTIVE COMPARATORCommunity intervention for ADHD
Interventions
The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.
The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.
The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling
TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
community intervention based on developmental approaches
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Physical disability, visual or hearing loss;
- Combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiu Xu, MD, PhD
Children's Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 20, 2019
Study Start
June 15, 2018
Primary Completion
June 30, 2021
Study Completion
July 30, 2021
Last Updated
January 11, 2022
Record last verified: 2021-01