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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719067
• Other study ID #: 201602058RIN
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Autism spectrum disorder (ASD) is a common severe, clinically and genetically heterogeneous childhood-onset neurodevelopmental disorder. Due to its high prevalence, typical autistic symptoms, and severe lifelong impairment without effective prevention and treatment, the developmental change of brain functions in individuals with this study has been recognized as one of the key topics of ASD. The goal of this project is to prospectively investigate the stability and changes of brain functions assessed by neuropsychological tests and neuroimages in a cohort of children and adolescents with ASD who had the first assessment 3-5 years ago.

Specific Aims: To investigate the stability and changes of neuropsychological and structural and functional connectivity among children and adolescents with ASD as compared to age- and sex-matched typically developing (TD) controls; and to identify predictors for these neurocognitive changes across a 3-5 follow-up period.

The investigators will prospectively follow up 70 ASDs and 70 TDs for reassessments of clinical symptoms, neuropsychological functions, and structural and functional brain connectivity. The assessments include ASD symptoms (ASD only: Autism Diagnostic Interview-Revised, Autism Diagnostic Observation Scale; all: Social Responsiveness Scale (SRS), Social Communication Questionnaires (SCQ), Autism Spectrum Quotient (AQ)), other psychiatric disorders (The Chinese version of the Kiddie Schedule of Schizophrenia and Affective Disorder Scale-Epidemiologic version, K-SADS-E), neuropsychological functions (Conner's Continuous Performance Test) and MRI assessments (T1 and T2 templates, Diffusion Spectrum Imaging, resting-state fMRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
Taiwan	National Taiwan Univeristy Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural neuroimaging	Using diffusing spectrum imaging (DSI) to assess the structural connectivity in brain circuitries	2 hours
Secondary	Neuropsychological functions	Conner's Continuous Performance Test (CCPT) is used to assess the sustained attention, cognitive controls, and vigilance	0.5 hour