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NCT Number: NCT03847402

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.

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Key information

Conditions

Brain Developmental Diseases Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Attention Deficit-Hyperactivity Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Communication Disorders Global Developmental Delay Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

The early integrated intervention for GDD

Behavioral

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

The early integrated intervention for ASD

Behavioral

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

The early integrated intervention for ADHD

Behavioral

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

community intervention for ASD

Behavioral

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

Community intervention for GDD

Behavioral

community intervention based on developmental approaches

community intervention for ADHD

Behavioral

School and family education

Primary outcomes

  1. Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD

    Time frame: 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

  2. Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD

    Time frame: 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

Secondary outcomes

  1. 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

    Time frame: 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

  2. Change from baseline intelligence quotient (IQ) in the Wechsler Intelligence Scale at 1 year, 2 years for ADHD

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • National Key Research and Development Program of China

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2019
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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