Mindreading in Adults With Autism Spectrum Disorder | NCT04010409

Studies
Mindreading in Adults With Autism Spectrum Disorder

NCT04010409

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

no intervention

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jul 4, 2019

First Submission Date that Met QC Criteria

Jul 4, 2019

First Posted Date

Jul 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.

Detailed Description

Autism spectrum disorder (ASD) is a clinical syndrome characterized by mindreading deficits, or Theory of Mind deficits. The Reading the Mind in the Eyes task (abbreviated as the Eyes task) was developed to assess the mindreading deficits as a hallmark of social deficits of ASD. This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. All the participants will complete clinical measures and the Eyes task. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASD Group		Autism spectrum disorder participants, no intervention	Other: no intervention
TD Group		Typically developmental controls,no intervention	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	ASD Group TD Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
eye tracking indicators	eye tracking indicators	30 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult aged between 20 and 50 years who had a diagnosis of ASD based on DSM-5.
Had a full-scale IQ > 70 on WAIS-IV.

Exclusion Criteria:

A history of major mental illness (e.g., bipolar affective disorder, schizophrenia) or neurological diseases.
Visual impairment and that would preclude participation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

The 30 adults with ASD will be recruited from Adult ASD clinics in Department of Psychiatry, National Taiwan University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Ling Chien, M.D., Ph.D.	Contact	886-2-2312-3456	66013	ylchien@hotmail.com

Overall Officials

Name	Affiliation	Role
Yi Ling Chien, M.D., Ph.D.	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38635133	Derived	Chien YL, Tseng YL, Tsai WC, Chiu YN. Assessing Frontal Lobe Function on Verbal Fluency and Emotion Recall in Autism Spectrum Disorder by fNIRS. J Autism Dev Disord. 2025 May;55(5):1648-1659. doi: 10.1007/s10803-024-06306-5. Epub 2024 Apr 18.

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders