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

Primary Purpose

Brain Developmental Diseases, Autism Spectrum Disorder, Global Developmental Delay

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The early integrated intervention for GDD
The early integrated intervention for ASD
The early integrated intervention for ADHD
community intervention for ASD
Community intervention for GDD
community intervention for ADHD
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Developmental Diseases

Eligibility Criteria

3 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Children's hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

GDD intervention

GDD non-intervention

ASD intervention

ASD non-intervention

ADHD intervention

ADHD non-intervention

Arm Description

The early integrated intervention for GDD

Community intervention for GDD

The early integrated intervention for ASD

Community intervention for ASD

The early integrated intervention for ADHD

Community intervention for ADHD

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 11, 2019
Last Updated
January 6, 2022
Sponsor
Children's Hospital of Fudan University
Collaborators
National Key Research and Development Program of China
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1. Study Identification

Unique Protocol Identification Number
NCT03847402
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
National Key Research and Development Program of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Developmental Diseases, Autism Spectrum Disorder, Global Developmental Delay, Attention Deficit-Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GDD intervention
Arm Type
Experimental
Arm Description
The early integrated intervention for GDD
Arm Title
GDD non-intervention
Arm Type
Active Comparator
Arm Description
Community intervention for GDD
Arm Title
ASD intervention
Arm Type
Experimental
Arm Description
The early integrated intervention for ASD
Arm Title
ASD non-intervention
Arm Type
Active Comparator
Arm Description
Community intervention for ASD
Arm Title
ADHD intervention
Arm Type
Experimental
Arm Description
The early integrated intervention for ADHD
Arm Title
ADHD non-intervention
Arm Type
Active Comparator
Arm Description
Community intervention for ADHD
Intervention Type
Behavioral
Intervention Name(s)
The early integrated intervention for GDD
Intervention Description
The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.
Intervention Type
Behavioral
Intervention Name(s)
The early integrated intervention for ASD
Intervention Description
The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.
Intervention Type
Behavioral
Intervention Name(s)
The early integrated intervention for ADHD
Intervention Description
The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling
Intervention Type
Behavioral
Intervention Name(s)
community intervention for ASD
Intervention Description
TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
Intervention Type
Behavioral
Intervention Name(s)
Community intervention for GDD
Intervention Description
community intervention based on developmental approaches
Intervention Type
Behavioral
Intervention Name(s)
community intervention for ADHD
Intervention Description
School and family education
Primary Outcome Measure Information:
Title
Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD
Description
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.
Title
Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
Description
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.
Secondary Outcome Measure Information:
Title
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
Description
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.
Title
Change from baseline intelligence quotient (IQ) in the Wechsler Intelligence Scale at 1 year, 2 years for ADHD
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiu Xu, MD, PhD
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

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

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