Precise Objective Automated Assessment System of Autism Spectrum Disorder From an Existing Big Cohort

NCT04875481 | Completed DMC

• 1 other identifier: 201801038RINB
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The project's significance includes a big cohort of Autism spectrum disorder (ASD), originality/novelty (new approaches and technologies including next-generation sequencing, multi-echo functional MRI, metabolomics, microbiomics, and machine learning), and the integration of multi-dimentional measures. With the accomplishment of this project, we will establish the most comprehensive ASD bio-bank in Asia, develop ASD NGS panel, identify several ASD biomarkers, publish at least 15 SCI papers in total, and in the end, have patents registration and technology transfer of our precise objective, automated assessment system for ASD. Our findings will further advance our understanding of ASD, ultimately contribute to the early detection, diagnosis, and treatment of ASD, and be the first step of precise medicine for ASD.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• Autism diagnostic interview (ADI-R)

  Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood

  4 hours

• Neuropsychological functions: Continuous Performance Test(CPT)

  The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance

  15 minutes

• Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)

  The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making

  1.5 hours

Study Arms (2)

ASD group

450 ASD from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007.

Other: Psychiatric diagnosis; Other: ASD diagnosis

TD group

100 healthy typical developing control (TDC) from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007.

Other: Psychiatric diagnosis

Interventions

Psychiatric diagnosis OTHER

Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5

ASD group; TD group

ASD diagnosis OTHER

Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)

ASD group

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The cohort was established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007. No less than 450 ASD and 100 healthy typical developing control (TDC) would be selected from the original cohort.

You may qualify if:

• Clinical diagnosis of ASD defined by the DSM-IV confirmed by ADI-R or ADOS
• At least one biological parent
• Parents are both Han Chinese in Taiwan

You may not qualify if:

• Schizophrenia
• Schizoaffective disorder
• Organic psychosis.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

20 mL of peripheral blood and 5 g of stool sample

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: August 1, 2018
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

TW (1)