Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02233348
Collaborator
(none)
523
1
60
8.7

Study Details

Study Description

Brief Summary

Autism spectrum disorders (ASD) is a common childhood-onset, multi-factorial, highly heritable, clinically and genetically heterogeneous, neurodevelopmental disorder. Due to its high prevalence and severe lifelong impairment without effective prevention and treatment, there is a dearth of investigating its pathogenesis, longitudinal outcome, and biomarkers (endophenotypes). The ultimate goals of this 5-year project are to prospectively investigate the outcome and changes of psychosocial and neurocognitive functions of a cohort of probands with ASD at adolescence and young adulthood as the primary aim; and to test whether structural and functional brain connectivity can be effective endophenotypes of ASD using the unaffected sibling and follow-up designs as the secondary aims.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary Aim:

    To investigate the neuropsychological, neuroimaging, social cognitive, and psychosocial outcomes at adolescence and young adulthood among children with ASD as compared to typically developing (TD) controls.

    Secondary Aims:
    1. To examine the changes and stability of ASD core symptoms, neuropsychological function, structured and functional connectivity, psychosocial functions over a 4-7 year follow-up period.

    2. To identify early individual (clinical, behavioral, and neurocognitive variables), family, school, environmental factors to predict the neurocognitive and psychosocial outcomes at adolescence and young adulthood.

    3. To validate the neuropsychological functioning (e.g., set-shifting, executive function, and visuo-spatial memory etc.) and structural (morphometric,, cortical thickness, gyrification, white matter tract integrity) and functional connectivity (resting-state and social task fMRI) in fronto-temporal, cortico-striato-thalamic, default mode network, and other circuits as effective imaging endophenotypes (biomarkers) by demonstrating the stability of these imaging data and the intermediate position of unaffected siblings between ASD probands and age-, sex-, handedness-, and IQ-matched TD at Time 1 and follow-up.

    4. To correlate the data from structural and functional connectivity, neuropsychology and ASD core symptoms stratifying by proband-unaffected sibling dyads, and different developmental stages.

    5. To collect blood sample, and to analyze neurodevelopmental and immune genes, cytokine level, and environmental exposure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    523 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder: a Follow-up Study
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    ASD group

    Subjects with DSM-IV ASD diagnosis

    Control group

    Controls without lifetime ASD or a family history of ASD

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of autism [one day]

      Using Autism Diagnostic Interview-Revised (ADI-R) to assess the developmental and behavioral aspects of autism, including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns.

    Secondary Outcome Measures

    1. Diagnosis of autism [one day]

      Using Autism Diagnostic Observation Scale (ADOS) to assess social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    ASD participants

    1. that they 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 7 years ago;

    2. their ages range from 10 to 25 (i.e., 3-18 years old at the first assessment);

    3. both parents are Han Chinese;

    4. who have complete clinical and behavioral data at the 1st assessment;

    5. participants and their parents consented to participate in this longitudinal study 7 years ago for complete assessments (3 visits of assessments) at follow-up.

    Inclusion Criteria for TD controls, who will be recruited either by school teachers or from the community, are that they are Han Chinese, consent to the study (if age <18, parents, too) to complete all the assessments.

    Exclusion Criteria:
    For TD controls:
    1. 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;

    2. comorbidity with neurological or systemic disorders; and

    3. having a first degree relative who may have ASD based on family history method assessment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan Univeristy Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Susan Shur-Fen Gau, MD, PhD, National Taiwan University Hospital & College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02233348
    Other Study ID Numbers:
    • 201403109RINC
    First Posted:
    Sep 8, 2014
    Last Update Posted:
    Sep 2, 2021
    Last Verified:
    Sep 1, 2021

    Study Results

    No Results Posted as of Sep 2, 2021