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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PEERS
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ASD group

Control group

Arm Description

autistic adolescents with their caregiver

healthy control without their caregiver

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
October 17, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05884853
Brief Title
The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
Official Title
The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
"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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASD group
Arm Type
Experimental
Arm Description
autistic adolescents with their caregiver
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
healthy control without their caregiver
Intervention Type
Behavioral
Intervention Name(s)
PEERS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Autism Diagnostic Interview Revised, ADIR
Description
Interview of the caregivers that covers most developmental and behavioral aspects of ASD. Range from 0 to 8, higher the score, worse the symptom.
Time Frame
16 weeks
Title
The Autism Diagnostic Observation Schedule, ADOS
Description
Diagnosing and assess autism. Range from 0 to 8, higher the score, worse the symptom.
Time Frame
16 weeks
Title
Autism Spectrum Quotient
Description
50 items, total score range from 0 to 50. Higher the score, worse the symptom
Time Frame
16 weeks
Title
Social Responsiveness Scale, Second Edition (SRS-2)
Description
65 items, total score range from 65 to 260. Higher the score, worse the symptom
Time Frame
16 weeks
Title
Quality of Socialization Questionnaire (QSQ)
Description
12 items, total score range from 0 to 12.Higher the score, better the frequency and quality of socialization
Time Frame
16 weeks
Title
The Empathy Quotient (EQ)
Description
40 items, total score range from 0 to 80. Higher the score, worse the empathy
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ling Chien, MD, PhD
Phone
+886223123456
Ext
66013
Email
chienyiling@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng Dist.
ZIP/Postal Code
100229
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Ling Chien, MD, PhD
Phone
+886223123456
Ext
66013
Email
chienyiling@gmail.com

12. IPD Sharing Statement

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

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