跳至主要内容
临床试验/NCT05884853
NCT05884853招募中不适用

The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Autism Diagnostic Interview Revised, ADIR

研究概览

简要总结

"Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age between 18 and 50
  • •diagnosed with ASD from licensed mental health or medical professional based on DSM5
  • •have social problems
  • •motivated to participate in the treatment
  • •fluent in chinese
  • •caregiver also fluent in chinese and motivated to participate
  • •had a full-scale IQ > 70 on WAIS-IV
  • •scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

排除标准

  • •history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases
  • •visual impairment and/or hearing impairment
  • •any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.

研究组 & 干预措施

ASD group

Experimental

autistic adolescents with their caregiver

干预措施: PEERS (Behavioral)

Control group

Sham Comparator

healthy control without their caregiver

干预措施: PEERS (Behavioral)

结局指标

主要结局

Autism Diagnostic Interview Revised, ADIR

时间窗: 16 weeks

Interview of the caregivers that covers most developmental and behavioral aspects of ASD. Range from 0 to 8, higher the score, worse the symptom.

The Empathy Quotient (EQ)

时间窗: 16 weeks

40 items, total score range from 0 to 80. Higher the score, worse the empathy

The Autism Diagnostic Observation Schedule, ADOS

时间窗: 16 weeks

Diagnosing and assess autism. Range from 0 to 8, higher the score, worse the symptom.

Autism Spectrum Quotient

时间窗: 16 weeks

50 items, total score range from 0 to 50. Higher the score, worse the symptom

Social Responsiveness Scale, Second Edition (SRS-2)

时间窗: 16 weeks

65 items, total score range from 65 to 260. Higher the score, worse the symptom

Quality of Socialization Questionnaire (QSQ)

时间窗: 16 weeks

12 items, total score range from 0 to 12.Higher the score, better the frequency and quality of socialization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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