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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
900
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
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, China
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
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.
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
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.
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
This is a parent-reported questionnaire widely used for screening communication disorders including ASD in infants and toddlers. The whole scale consists of 24 items divided into three subscales (social, speech, and symbolic composite) and an open question at the end. The changes in raw scores of each subscale and the whole scale partly reflect the change in social communication skills of children.This is a repeate measurement
Time frame: 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.
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TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
community intervention based on developmental approaches
School and family education
Change from baseline intelligence quotient (IQ) in the Wechsler Intelligence Scale at 1 year, 2 years for ADHD
Wechsler Intelligence Scale consists of 2 subscales, which are verbal scale and performance scale. The intelligence quotient (IQ) are referred from the norms. Higher IQ represent a better outcome.This is a repeate measurement
Time frame: from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years