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

October 17, 2023 updated by: National Taiwan University Hospital
"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Zhongzheng Dist.
      • Taipei, Zhongzheng Dist., Taiwan, 100229
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASD group
autistic adolescents with their caregiver
Behavioral: PEERS
The Program for the Education and Enrichment of Relational Skills (PEERS®) studies is an evidence-based 16-week group-based social skill training program developed for adolescents and young adults with ASD.
Sham Comparator: Control group
healthy control without their caregiver
Behavioral: PEERS
The Program for the Education and Enrichment of Relational Skills (PEERS®) studies is an evidence-based 16-week group-based social skill training program developed for adolescents and young adults with ASD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autism Diagnostic Interview Revised, ADIR
Time Frame: 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.
16 weeks
The Autism Diagnostic Observation Schedule, ADOS
Time Frame: 16 weeks
Diagnosing and assess autism. Range from 0 to 8, higher the score, worse the symptom.
16 weeks
Autism Spectrum Quotient
Time Frame: 16 weeks
50 items, total score range from 0 to 50. Higher the score, worse the symptom
16 weeks
Social Responsiveness Scale, Second Edition (SRS-2)
Time Frame: 16 weeks
65 items, total score range from 65 to 260. Higher the score, worse the symptom
16 weeks
Quality of Socialization Questionnaire (QSQ)
Time Frame: 16 weeks
12 items, total score range from 0 to 12.Higher the score, better the frequency and quality of socialization
16 weeks
The Empathy Quotient (EQ)
Time Frame: 16 weeks
40 items, total score range from 0 to 80. Higher the score, worse the empathy
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202012163RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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