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

Fudan University

Status: Completed

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

Treatments: Behavioral: community intervention for ASD; Behavioral: The early integrated intervention for ASD; Behavioral: community intervention for ADHD; Behavioral: The early integrated intervention for GDD; Behavioral: Community intervention for GDD; Behavioral: The early integrated intervention for ADHD

Study type: Interventional

Funder types: Other

Identifiers

NCT03847402

MBDZXGY2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 patients

Sex: All

Ages: 3 months to 3 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 6 patient groups

GDD intervention

Experimental group

Description:

The early integrated intervention for GDD

Treatment:

Behavioral: The early integrated intervention for GDD

GDD non-intervention

Active Comparator group

Description:

Community intervention for GDD

Treatment:

Behavioral: Community intervention for GDD

ASD intervention

Experimental group

Description:

The early integrated intervention for ASD

Treatment:

Behavioral: The early integrated intervention for ASD

ASD non-intervention

Active Comparator group

Description:

Community intervention for ASD

Treatment:

Behavioral: community intervention for ASD

ADHD intervention

Experimental group

Description:

The early integrated intervention for ADHD

Treatment:

Behavioral: The early integrated intervention for ADHD

ADHD non-intervention

Active Comparator group

Description:

Community intervention for ADHD

Treatment:

Behavioral: community intervention for ADHD