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

Not Applicable

Completed

• Conditions: Brain Developmental Diseases; Autism Spectrum Disorder; Global Developmental Delay; Attention Deficit-Hyperactivity Disorder
• Interventions: Behavioral: The early integrated intervention for ASD; Behavioral: The early integrated intervention for GDD; Behavioral: community intervention for ASD; Behavioral: The early integrated intervention for ADHD; Behavioral: community intervention for ADHD; Behavioral: Community intervention for GDD

• Registration Number: NCT03847402
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Status Verified: 2021-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASD intervention	The early integrated intervention for ASD	The early integrated intervention for ASD
GDD intervention	The early integrated intervention for GDD	The early integrated intervention for GDD
ASD non-intervention	community intervention for ASD	Community intervention for ASD
ADHD intervention	The early integrated intervention for ADHD	The early integrated intervention for ADHD
ADHD non-intervention	community intervention for ADHD	Community intervention for ADHD
GDD non-intervention	Community intervention for GDD	Community intervention for GDD

Primary Outcome Measures

Name	Time	Method
Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD	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.	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
Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD	from enrollment to end of intervention (2 years). The DQ will be measured at the following time point: enrollment, 1 year, 2 years.	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

Secondary Outcome Measures

Name	Time	Method
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.	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	from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years	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

Trial Locations

Locations (1)

Children's hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China