NCT05884853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 18, 2023

Status Verified

May 1, 2023

Enrollment Period

3.6 years

First QC Date

May 4, 2023

Last Update Submit

October 17, 2023

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (6)

  • 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.

    16 weeks

  • The Autism Diagnostic Observation Schedule, ADOS

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

    16 weeks

  • Autism Spectrum Quotient

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

    16 weeks

  • Social Responsiveness Scale, Second Edition (SRS-2)

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

    16 weeks

  • Quality of Socialization Questionnaire (QSQ)

    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)

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

    16 weeks

Study Arms (2)

ASD group

EXPERIMENTAL

autistic adolescents with their caregiver

Behavioral: PEERS

Control group

SHAM COMPARATOR

healthy control without their caregiver

Behavioral: PEERS

Interventions

PEERSBEHAVIORAL

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.

ASD groupControl group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 100229, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Yi-Ling Chien, MD, PhD

CONTACT

+886223123456chienyiling@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

June 1, 2023

Study Start

January 1, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

October 18, 2023

Record last verified: 2023-05

Locations

TW(1)