AutismNCT02807766
Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
A study testing Behavior modification, Behavior modification and sensory integration training and Behavior modification and applied behavioral analysis in people with Autism, run by University of Electronic Science and Technology of China at 2 sites in China.
Trial summary
Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Behavior modification, Behavior modification and sensory integration training and Behavior modification and applied behavioral analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- May 2016to Dec 2024
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range from 2 to 8 years old.
- Clinical DSM-IV diagnosis of autism.
Who cannot join
- Subjects with other neurodevelopmental diseases.
- Subjects with contraindications to MRI.
Trial locations and contacts
2 sites in 1 country.
Huafu Chen contact
China2 sites, 2 recruiting
- Recruiting
Center for Information in BioMedicine, Key laboratory for NeuroInformation of Ministry of Education, School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
Huafu Chen, chenhf@uestc.edu.cn
Huafu Chen
- Recruiting
Department of Children's and Adolescent Health, Public Health College of Harbin Medical University
Harbin, Heilongjiang, 150086
Lijie Wu, wangjiahyd@163.com
About this study
Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.
Read the detailed description
Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators collect participants' brain imaging data, eye movement data, stool samples and clinical scale score before and after intervention. Investigators first investigate longitudinal effect of behavioral intervention on brain structure and function in children with autism. In addition, investigators provide new biological indexes upon multimodal large-scale brain connectomes to evaluate the curative effect of intervention. Finally, investigators propose a prediction model of intervention effect based on multimodal multivariate pattern analysis methods. Furthermore, investigators expect to map the state-of-the-art biomarkers on multi-modal networks to provide a new interpretation of pathophysiological mechanisms of autism.
- Conditions
- Autism
- Being tested
- Behavior modification, Behavior modification and sensory integration training, Behavior modification and applied behavioral analysis, Behavior modification and TEACCH
- Keywords
- autism, Brain Plasticity, Behavioral Intervention, Magnetic Resonance Imaging
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior modificationBehavioural
Each group has 30 subjects and experiences six months' training.
Behavior modification and sensory integration trainingBehavioural
Each group has 30 subjects and experiences six months' training.
Behavior modification and applied behavioral analysisBehavioural
Each group has 30 subjects and experiences six months' training.
Behavior modification and TEACCHBehavioural
Each group has 30 subjects and experiences six months' training.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Integration Training | Experimental | Behavior modification and Sensory Integration Training Receives: Behavioral: Behavior modification and sensory integration training |
| applied behavioral analysis | Experimental | Behavior modification and applied behavioral analysis. Receives: Behavioral: Behavior modification and applied behavioral analysis |
| TEACCH | Experimental | Behavior modification and TEACCH. Receives: Behavioral: Behavior modification and TEACCH |
| Behavior modification | Other | Behavior modification. Receives: Behavioral: Behavior modification |
| healthy control group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structural and functional change under behavioral intervention at 6 months in children with autism
Longitudinal effect of behavioral intervention on brain structure and function in children with autism will be assessed by Voxel-based morphometry analysis for structural changes, as well as Regional homogeneity, Amplitude of low-frequency fluctuation, etc, for functional changes.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Prediction model of intervention effect based on multimodal multivariate pattern analysis methods
First, classify autism individuals into effective treatment group and ineffective treatment group according to the intervention effect at 6 months. Second, conduct feature selection with Sparse optimization algorithms and cluster analysis on MRI data. Third, design optimized classifiers integrated support vector machines and Gaussian Naive Bayes classifiers.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huafu Chen, University of Electronic Science and Technology of China
- Investigators
- Huafu Chen, Principal investigator, School of Life Science and Technology, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807766
- Sponsor's protocol ID
- UESTC-chenhuafulab-001
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2016
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Huang X, Ming Y, Zhao W, Feng R, Zhou Y, Wu L, Wang J, Xiao J, Li L, Shan X, Cao J, Kang X, Chen H, Duan X. Developmental prediction modeling based on diffusion tensor imaging uncovering age-dependent heterogeneity in early childhood autistic brain. Mol Autism. 2023 Oct 30;14(1):41. doi: 10.1186/s13229-023-00573-2.
PubMed 37899464Guo X, Duan X, Suckling J, Wang J, Kang X, Chen H, Biswal BB, Cao J, He C, Xiao J, Huang X, Wang R, Han S, Fan YS, Guo J, Zhao J, Wu L, Chen H. Mapping Progressive Gray Matter Alterations in Early Childhood Autistic Brain. Cereb Cortex. 2021 Feb 5;31(3):1500-1510. doi: 10.1093/cercor/bhaa304.
PubMed 33123725
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
- ClinicalTrials.gov ID
- NCT02807766
- Acronym / sponsor ID
- UESTC-chenhuafulab-001
- Conditions
- Autism
- Keywords
- autism, Brain Plasticity, Behavioral Intervention, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- 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.
Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.
Detailed description
Autism is a well-recognized neurodevelopmental disorder severely affecting the health of children. While the unclear neurobiological basis of autism and the lack of effective medication, the most commonly used approach for treatment is behavioral intervention. However, the pathophysiological mechanisms underlying the intervention therapy remains incompletely understood. The current project aims to explore the impacts of different early behavioral intervention methods on brain plasticity of autism using multimodal MRI technique and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators collect participants' brain imaging data, eye movement data, stool samples and clinical scale score before and after intervention. Investigators first investigate longitudinal effect of behavioral intervention on brain structure and function in children with autism. In addition, investigators provide new biological indexes upon multimodal large-scale brain connectomes to evaluate the curative effect of intervention. Finally, investigators propose a prediction model of intervention effect based on multimodal multivariate pattern analysis methods. Furthermore, investigators expect to map the state-of-the-art biomarkers on multi-modal networks to provide a new interpretation of pathophysiological mechanisms of autism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sensory Integration Training | Experimental | Behavioral: Behavior modification and sensory integration trainingBehavior modification and Sensory Integration Training |
| applied behavioral analysis | Experimental | Behavioral: Behavior modification and applied behavioral analysisBehavior modification and applied behavioral analysis. |
| TEACCH | Experimental | Behavioral: Behavior modification and TEACCHBehavior modification and TEACCH. |
| Behavior modification | Other | Behavioral: Behavior modificationBehavior modification. |
| healthy control group | No intervention | –No intervention. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age range from 2 to 8 years old.
- Clinical DSM-IV diagnosis of autism.
Key exclusion criteria (2 listed)
- Subjects with other neurodevelopmental diseases.
- Subjects with contraindications to MRI.
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 |
|---|---|---|
| Behavior modificationEach group has 30 subjects and experiences six months' training. | Behavioural | Behavior modification |
| Behavior modification and sensory integration trainingEach group has 30 subjects and experiences six months' training. | Behavioural | Sensory Integration Training |
| Behavior modification and applied behavioral analysisEach group has 30 subjects and experiences six months' training. | Behavioural | applied behavioral analysis |
| Behavior modification and TEACCHEach group has 30 subjects and experiences six months' training. | Behavioural | TEACCH |
Primary outcome
Brain structural and functional change under behavioral intervention at 6 months in children with autism
Time frame: through study completion, an average of 1 year
Longitudinal effect of behavioral intervention on brain structure and function in children with autism will be assessed by Voxel-based morphometry analysis for structural changes, as well as Regional homogeneity, Amplitude of low-frequency fluctuation, etc, for functional changes.
1 secondary outcome
Prediction model of intervention effect based on multimodal multivariate pattern analysis methods
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 37899464Huang X, Ming Y, Zhao W, Feng R, Zhou Y, Wu L, Wang J, Xiao J, Li L, Shan X, Cao J, Kang X, Chen H, Duan X. Developmental prediction modeling based on diffusion tensor imaging uncovering age-dependent heterogeneity in early childhood autistic brain. Mol Autism. 2023 Oct 30;14(1):41. doi: 10.1186/s13229-023-00573-2.
- Derived from this study: PubMed 33123725Guo X, Duan X, Suckling J, Wang J, Kang X, Chen H, Biswal BB, Cao J, He C, Xiao J, Huang X, Wang R, Han S, Fan YS, Guo J, Zhao J, Wu L, Chen H. Mapping Progressive Gray Matter Alterations in Early Childhood Autistic Brain. Cereb Cortex. 2021 Feb 5;31(3):1500-1510. doi: 10.1093/cercor/bhaa304.
- Individual participant dataSharing planned: Undecided
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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.
Huafu Chen contact
Huafu Chen principal investigator
School of Life Science and Technology, University of Electronic Science and Technology of China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior modification, Behavior modification and sensory integration training and Behavior modification and applied behavioral analysis in people with Autism, run by University of Electronic Science and Technology of China at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafu Chen (chenhf@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structural and functional change under behavioral intervention at 6 months in children with autism (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807766, which also lists 2 linked publications.
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 16 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.