A Longitudinal Follow-up Imaging Study on Children and Adolescents With Autism Spectrum Disorder

NCT02719067 | Completed DMC

• 1 other identifier: 201602058RIN
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The significance of this project is the first longitudinal study to investigate the changes of neurocognitive functions of children and adolescents with ASD and to identify the potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition to single-echo resting-state fMRI). The success of this project will fill the gap of our understanding of longitudinal changes of brain function by neuropsychological and imaging approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of translational research in ASD.

Conditions

Autism Spectrum Disorder

Keywords

neuropsychological function; neuroimage; developmental changes

Outcome Measures

Primary Outcomes (1)

• Structural neuroimaging

  Using diffusing spectrum imaging (DSI) to assess the structural connectivity in brain circuitries

  2 hours

Secondary Outcomes (1)

• Neuropsychological functions

  0.5 hour

Study Arms (2)

ASD group

Subjects have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV and ICD-10 criteria

TD group

Typically developing controls without lifetime ASD or a family history of ASD

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

70 ASDs, aged 12-20, from the cohort of ASD established by previous imaging studies supported by National Science Council(NSC),Taiwan (now Ministry of Science and Technology, MOST), who consented to this follow-up study at their first assessments in 2010-2014 and 70 age-, and sex-matched TD.

You may qualify if:

• ASD group:
• have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV and ICD-10 criteria, made by board-certificated child psychiatrists and who were clinically diagnosed with ASD confirmed by the ADI-R 3-5 years ago
• ages range from 12 to 20 (i.e., 7-17 years old at the first assessment)
• both parents are Han Chinese
• have complete clinical and behavioral data at the 1st assessment
• participants and their parents consented to participate in this longitudinal study 3-5 years ago for complete assessments at follow-up.
• TD group:
• ages range from 12 to 20
• both parents are Han Chinese

You may not qualify if:

• comorbidity with DSM-IV-TR or DSM-5 diagnoses of ASD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use
• comorbidity with neurological or systemic disorders
• having a first degree relative who may have ASD based on family history method assessment.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Susan Shur-Fen Gau, MD, PhD

  National Taiwan University Hospital & College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 25, 2016
• Study Start: January 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

TW (1)