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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847402
• Other study ID #: MBDZXGY2018
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 3 Years

Eligibility

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;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit-Hyperactivity Disorder
• Autism Spectrum Disorder
• Brain Developmental Diseases
• Developmental Disabilities
• Disease
• Global Developmental Delay

Intervention

Behavioral:
• The early integrated intervention for GDD
The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.
• The early integrated intervention for ASD
The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.
• The early integrated intervention for ADHD
The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling
• community intervention for ASD
TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
• Community intervention for GDD
community intervention based on developmental approaches
• community intervention for ADHD
School and family education

Locations

Country	Name	City	State
China	Children's hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	National Key Research and Development Program of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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