Brain Developmental DiseasesNCT03847402
The Early Integrated Intervention for Child Brain-developmental Disorders in China
A study testing The early integrated intervention for GDD, The early integrated intervention for ASD and The early integrated intervention for ADHD in people with Brain Developmental Diseases and Autism Spectrum Disorder, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Brain Developmental Diseases, Autism Spectrum Disorder, Global Developmental Delay
- What is being tested?
- The early integrated intervention for GDD, The early integrated intervention for ASD and The early integrated intervention for ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Physical disability, visual or hearing loss;
- Combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Developmental Diseases, Autism Spectrum Disorder, Global Developmental Delay, Attention Deficit-Hyperactivity Disorder
- Being tested
- The early integrated intervention for GDD, The early integrated intervention for ASD, The early integrated intervention for ADHD, community intervention for ASD, Community intervention for GDD
- Medical subject headings
- Autism Spectrum Disorder, Learning Disabilities, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The early integrated intervention for GDDBehavioural
The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.
The early integrated intervention for ASDBehavioural
The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.
The early integrated intervention for ADHDBehavioural
The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling
community intervention for ASDBehavioural
TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
Community intervention for GDDBehavioural
community intervention based on developmental approaches
community intervention for ADHDBehavioural
School and family education
| Study group | Role | What they receive |
|---|---|---|
| GDD intervention | Experimental | The early integrated intervention for GDD Receives: Behavioral: The early integrated intervention for GDD |
| GDD non-intervention | Active comparator | Community intervention for GDD Receives: Behavioral: Community intervention for GDD |
| ASD intervention | Experimental | The early integrated intervention for ASD Receives: Behavioral: The early integrated intervention for ASD |
| ASD non-intervention | Active comparator | Community intervention for ASD Receives: Behavioral: community intervention for ASD |
| ADHD intervention | Experimental | The early integrated intervention for ADHD Receives: Behavioral: The early integrated intervention for ADHD |
| ADHD non-intervention | Active comparator | Community intervention for ADHD Receives: Behavioral: community intervention for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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 outcomes (2)
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
Measured: 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
Measured: from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start15 Jun 2018
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Developmental DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, MD, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847402
- Sponsor's protocol ID
- MBDZXGY2018
- Status last verified
- Jan 2021
- First submitted
- 11 Feb 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China
- ClinicalTrials.gov ID
- NCT03847402
- Acronym / sponsor ID
- MBDZXGY2018
- Conditions
- Brain Developmental Diseases, Autism Spectrum Disorder, Global Developmental Delay, Attention Deficit-Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GDD intervention | Experimental | Behavioral: The early integrated intervention for GDDThe early integrated intervention for GDD |
| GDD non-intervention | Active comparator | Behavioral: Community intervention for GDDCommunity intervention for GDD |
| ASD intervention | Experimental | Behavioral: The early integrated intervention for ASDThe early integrated intervention for ASD |
| ASD non-intervention | Active comparator | Behavioral: community intervention for ASDCommunity intervention for ASD |
| ADHD intervention | Experimental | Behavioral: The early integrated intervention for ADHDThe early integrated intervention for ADHD |
| ADHD non-intervention | Active comparator | Behavioral: community intervention for ADHDCommunity intervention for ADHD |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Physical disability, visual or hearing loss;
- Combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The early integrated intervention for GDDThe early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis. | Behavioural | GDD intervention |
| The early integrated intervention for ASDThe theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model. | Behavioural | ASD intervention |
| The early integrated intervention for ADHDThe methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling | Behavioural | ADHD intervention |
| community intervention for ASDTEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention | Behavioural | ASD non-intervention |
| Community intervention for GDDcommunity intervention based on developmental approaches | Behavioural | GDD non-intervention |
| community intervention for ADHDSchool and family education | Behavioural | ADHD non-intervention |
Primary outcome
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
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
2 secondary outcomes
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiu Xu, MD, PhD principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The early integrated intervention for GDD, The early integrated intervention for ASD and The early integrated intervention for ADHD in people with Brain Developmental Diseases and Autism Spectrum Disorder, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.