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

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT03847402
Collaborator
National Key Research and Development Program of China (Other)
900
Enrollment
1
Location
6
Arms
37.5
Actual Duration (Months)
24
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: The early integrated intervention for GDD
  • Behavioral: The early integrated intervention for ASD
  • Behavioral: The early integrated intervention for ADHD
  • Behavioral: community intervention for ASD
  • Behavioral: Community intervention for GDD
  • Behavioral: community intervention for ADHD
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China
Actual Study Start Date :
Jun 15, 2018
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Secondary Outcome Measures

  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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Children's hospital of Fudan UniversityShanghaiShanghaiChina201102

Sponsors and Collaborators

  • Children's Hospital of Fudan University
  • National Key Research and Development Program of China

Investigators

  • Principal Investigator: Xiu Xu, MD, PhD, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT03847402
Other Study ID Numbers:
  • MBDZXGY2018
First Posted:
Feb 20, 2019
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022