The Early Integrated Intervention for Child Brain-developmental Disorders in China

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China

Conditions
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Brain Developmental Diseases, Autism Spectrum Disorder, Global Developmental Delay, Attention Deficit-Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: The early integrated intervention for GDD
* Behavioral: The early integrated intervention for ASD
* Behavioral: The early integrated intervention for ADHD
* Behavioral: community intervention for ASD
* Behavioral: Community intervention for GDD
* Behavioral: community intervention for ADHD


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDD intervention<br>The early integrated intervention for GDD | Behavioral: The early integrated intervention for GDD<br>* The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.<br>|
| Active Comparator: GDD non-intervention<br>Community intervention for GDD | Behavioral: Community intervention for GDD<br>* community intervention based on developmental approaches<br>|
| Experimental: ASD intervention<br>The early integrated intervention for ASD | Behavioral: The early integrated intervention for ASD<br>* The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.<br>|
| Active Comparator: ASD non-intervention<br>Community intervention for ASD | Behavioral: community intervention for ASD<br>* TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention<br>|
| Experimental: ADHD intervention<br>The early integrated intervention for ADHD | Behavioral: The early integrated intervention for ADHD<br>* The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling<br>|
| Active Comparator: ADHD non-intervention<br>Community intervention for ADHD | Behavioral: community intervention for ADHD<br>* School and family education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years |