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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GDD intervention; The early integrated intervention for GDD	Behavioral: The early integrated intervention for GDD; The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.
ACTIVE_COMPARATOR: GDD non-intervention; Community intervention for GDD	Behavioral: Community intervention for GDD; community intervention based on developmental approaches
EXPERIMENTAL: ASD intervention; The early integrated intervention for ASD	Behavioral: The early integrated intervention for ASD; The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.
ACTIVE_COMPARATOR: ASD non-intervention; Community intervention for ASD	Behavioral: community intervention for ASD; TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
EXPERIMENTAL: ADHD intervention; The early integrated intervention for ADHD	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
ACTIVE_COMPARATOR: ADHD non-intervention; Community intervention for ADHD	Behavioral: community intervention for ADHD; School and family education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: National Key Research and Development Program of China
• Investigators: Principal Investigator: Xiu Xu, MD, PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Developmental Disabilities
• Other Study ID Numbers: MBDZXGY2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No