Brain Plasticity of Autism in Response to Early Behavioral Intervention: A Multimodal MRI Study
1 other identifier
interventional
150
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 16, 2024
January 1, 2024
8.6 years
June 13, 2016
January 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
through study completion, an average of 1 year
Secondary Outcomes (1)
Prediction model of intervention effect based on multimodal multivariate pattern analysis methods
through study completion, an average of 1 year
Study Arms (5)
Sensory Integration Training
EXPERIMENTALBehavior modification and Sensory Integration Training
applied behavioral analysis
EXPERIMENTALBehavior modification and applied behavioral analysis.
TEACCH
EXPERIMENTALBehavior modification and TEACCH.
Behavior modification
OTHERBehavior modification.
healthy control group
NO INTERVENTIONNo intervention.
Interventions
Each group has 30 subjects and experiences six months' training.
Each group has 30 subjects and experiences six months' training.
Each group has 30 subjects and experiences six months' training.
Each group has 30 subjects and experiences six months' training.
Eligibility Criteria
You may qualify if:
- Age range from 2 to 8 years old.
- Clinical DSM-IV diagnosis of autism.
You may not qualify if:
- Subjects with other neurodevelopmental diseases.
- Subjects with contraindications to MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Children's and Adolescent Health, Public Health College of Harbin Medical University
Harbin, Heilongjiang, 150086, China
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, China
Related Publications (2)
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.
PMID: 37899464DERIVEDGuo 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.
PMID: 33123725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huafu Chen
School of Life Science and Technology, University of Electronic Science and Technology of China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 21, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 16, 2024
Record last verified: 2024-01