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

NCT ID: NCT03847402

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2021-07-30

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GDD intervention

The early integrated intervention for GDD

Group Type EXPERIMENTAL

The early integrated intervention for GDD

Intervention Type BEHAVIORAL

The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.

GDD non-intervention

Community intervention for GDD

Group Type ACTIVE_COMPARATOR

Community intervention for GDD

Intervention Type BEHAVIORAL

community intervention based on developmental approaches

ASD intervention

The early integrated intervention for ASD

Group Type EXPERIMENTAL

The early integrated intervention for ASD

Intervention Type BEHAVIORAL

The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.

ASD non-intervention

Community intervention for ASD

Group Type ACTIVE_COMPARATOR

community intervention for ASD

Intervention Type BEHAVIORAL

TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention

ADHD intervention

The early integrated intervention for ADHD

Group Type EXPERIMENTAL

The early integrated intervention for ADHD

Intervention Type BEHAVIORAL

The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling

ADHD non-intervention

Community intervention for ADHD

Group Type ACTIVE_COMPARATOR

community intervention for ADHD

Intervention Type BEHAVIORAL

School and family education

Interventions

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The early integrated intervention for GDD

The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.

Intervention Type BEHAVIORAL

The early integrated intervention for ASD

The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.

Intervention Type BEHAVIORAL

The early integrated intervention for ADHD

The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling

Intervention Type BEHAVIORAL

community intervention for ASD

TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention

Intervention Type BEHAVIORAL

Community intervention for GDD

community intervention based on developmental approaches

Intervention Type BEHAVIORAL

community intervention for ADHD

School and family education

Intervention Type BEHAVIORAL

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;
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Key Research and Development Program of China

UNKNOWN

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiu Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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MBDZXGY2018

Identifier Type: -

Identifier Source: org_study_id

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