A Deep Learning Algorithm Platform to Predict Autism Diagnosis and Subtypes

NCT04873674 | Unknown DMC

• 1 other identifier: 202002086RIND
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first human study on ASD microbiome with robust methodologies: prospective and sibling designs, metagenomics profiles, establishing an ASD multi-dimensional databank (clinic, behavior, neurocognition, brain imaging, metabolomics, and microbiome) collected using the same methodology and genetic biology simultaneously, and developing a deep learning platform for ASD diagnosis and prevention. With the accomplishment of this project, we anticipate establishing a web application for clinical and academic use. Our findings will further advance the knowledge in the pathogenetic mechanisms of ASD to enhance early detection, diagnosis, and treatment, subsequently contributing to precision medicine.

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 (3)

ASD group

240 ASD patients (aged 4-25 years)

Other: ASD diagnosis; Other: Psychiatric diagnosis

Unaffected siblings of ASD

60-100 unaffected siblings of ASD probands

Other: Psychiatric diagnosis

TD group

120 age-, and sex matched TDC from the same geographic areas of the ASD group via referral by teachers, or advertisement at college or community.

Other: Psychiatric diagnosis

Interventions

ASD diagnosis OTHER

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

ASD group

Psychiatric diagnosis OTHER

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

ASD group; TD group; Unaffected siblings of ASD

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 sample includes 240 ASD (aged 4 to 25 years), 60\~100 (estimated average 80) unaffected siblings (US), and 120 TDC. 240 ASD and 80 US, aged 4-25 will be recruited from the ASD follow-up cohort established by PI Gau's NHRI project or the Department of Psychiatry of all the branches of NTUH.

You may qualify if:

• ASD participants are (1) they have a clinical diagnosis of ASD defined by the DSM-5 criteria,1 made by board-certificated child psychiatrists and confirmed by the ADI-R/ADOS; (2) their ages range from 4 to 25; (3) both parents are Han Chinese; (4) they and their parents cooperate with all the assessments and stool and blood collection.

You may not qualify if:

• (1) comorbidity with DSM-5 diagnoses of schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorders, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) comorbidity with neurological or systemic disorders; and (3) having a first degree relative who may have ASD based on family history method assessment (the TDC group).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

metabolite (blood) and intestinal microbial (stool)

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 5, 2021
• Study Start: May 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

TW (1)