Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study

NCT ID: NCT02807766

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sensory Integration Training

Behavior modification and Sensory Integration Training

Group Type EXPERIMENTAL

Behavior modification and sensory integration training

Intervention Type BEHAVIORAL

Each group has 30 subjects and experiences six months' training.

applied behavioral analysis

Behavior modification and applied behavioral analysis.

Group Type EXPERIMENTAL

Behavior modification and applied behavioral analysis

Intervention Type BEHAVIORAL

Each group has 30 subjects and experiences six months' training.

TEACCH

Behavior modification and TEACCH.

Group Type EXPERIMENTAL

Behavior modification and TEACCH

Intervention Type BEHAVIORAL

Each group has 30 subjects and experiences six months' training.

Behavior modification

Behavior modification.

Group Type OTHER

Behavior modification

Intervention Type BEHAVIORAL

Each group has 30 subjects and experiences six months' training.

healthy control group

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavior modification

Each group has 30 subjects and experiences six months' training.

Intervention Type BEHAVIORAL

Behavior modification and sensory integration training

Each group has 30 subjects and experiences six months' training.

Intervention Type BEHAVIORAL

Behavior modification and applied behavioral analysis

Each group has 30 subjects and experiences six months' training.

Intervention Type BEHAVIORAL

Behavior modification and TEACCH

Each group has 30 subjects and experiences six months' training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age range from 2 to 8 years old.
* Clinical DSM-IV diagnosis of autism.

Exclusion Criteria

* Subjects with other neurodevelopmental diseases.
* Subjects with contraindications to MRI.
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Huafu Chen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huafu Chen

Role: PRINCIPAL_INVESTIGATOR

School of Life Science and Technology, University of Electronic Science and Technology of China

Locations

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Department of Children's and Adolescent Health, Public Health College of Harbin Medical University

Harbin, Heilongjiang, China

Site Status 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, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huafu Chen

Role: CONTACT

Facility Contacts

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Lijie Wu

Role: primary

Huafu Chen

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37899464 (View on PubMed)

Guo 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.

Reference Type DERIVED
PMID: 33123725 (View on PubMed)

Other Identifiers

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UESTC-chenhuafulab-001

Identifier Type: -

Identifier Source: org_study_id

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