<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233348</url>
  </required_header>
  <id_info>
    <org_study_id>201403109RINC</org_study_id>
    <nct_id>NCT02233348</nct_id>
  </id_info>
  <brief_title>Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder</brief_title>
  <official_title>Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder: a Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autism spectrum disorders (ASD) is a common childhood-onset, multi-factorial, highly&#xD;
      heritable, clinically and genetically heterogeneous, neurodevelopmental disorder. Due to its&#xD;
      high prevalence and severe lifelong impairment without effective prevention and treatment,&#xD;
      there is a dearth of investigating its pathogenesis, longitudinal outcome, and biomarkers&#xD;
      (endophenotypes). The ultimate goals of this 5-year project are to prospectively investigate&#xD;
      the outcome and changes of psychosocial and neurocognitive functions of a cohort of probands&#xD;
      with ASD at adolescence and young adulthood as the primary aim; and to test whether&#xD;
      structural and functional brain connectivity can be effective endophenotypes of ASD using the&#xD;
      unaffected sibling and follow-up designs as the secondary aims.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Aim:&#xD;
&#xD;
      To investigate the neuropsychological, neuroimaging, social cognitive, and psychosocial&#xD;
      outcomes at adolescence and young adulthood among children with ASD as compared to typically&#xD;
      developing (TD) controls.&#xD;
&#xD;
      Secondary Aims:&#xD;
&#xD;
        1. To examine the changes and stability of ASD core symptoms, neuropsychological function,&#xD;
           structured and functional connectivity, psychosocial functions over a 4-7 year follow-up&#xD;
           period.&#xD;
&#xD;
        2. To identify early individual (clinical, behavioral, and neurocognitive variables),&#xD;
           family, school, environmental factors to predict the neurocognitive and psychosocial&#xD;
           outcomes at adolescence and young adulthood.&#xD;
&#xD;
        3. To validate the neuropsychological functioning (e.g., set-shifting, executive function,&#xD;
           and visuo-spatial memory etc.) and structural (morphometric,, cortical thickness,&#xD;
           gyrification, white matter tract integrity) and functional connectivity (resting-state&#xD;
           and social task fMRI) in fronto-temporal, cortico-striato-thalamic, default mode&#xD;
           network, and other circuits as effective imaging endophenotypes (biomarkers) by&#xD;
           demonstrating the stability of these imaging data and the intermediate position of&#xD;
           unaffected siblings between ASD probands and age-, sex-, handedness-, and IQ-matched TD&#xD;
           at Time 1 and follow-up.&#xD;
&#xD;
        4. To correlate the data from structural and functional connectivity, neuropsychology and&#xD;
           ASD core symptoms stratifying by proband-unaffected sibling dyads, and different&#xD;
           developmental stages.&#xD;
&#xD;
        5. To collect blood sample, and to analyze neurodevelopmental and immune genes, cytokine&#xD;
           level, and environmental exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of autism</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of autism</measure>
    <time_frame>one day</time_frame>
    <description>Using Autism Diagnostic Observation Scale (ADOS) to assess social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">523</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>ASD group</arm_group_label>
    <description>Subjects with DSM-IV ASD diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Controls without lifetime ASD or a family history of ASD</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The subjects will receive blood withdrawal. The blood sample will be used for establishing&#xD;
      lymphoblastoid cell lines, which will be used for molecular genetic experiments&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        373 ASD, aged 10-25, from the cohort of ASD established by NRPGM, who consented to this&#xD;
        follow-up study at their first assessments in 2007-2011 and 150 age-, and sex-matched TD,&#xD;
        at the ratio of 2:1.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ASD participants&#xD;
&#xD;
          1. that they have a clinical diagnosis of autistic disorder or Asperger disorder defined&#xD;
             by the DSM-IV and ICD-10 criteria, made by board-certificated child psychiatrists and&#xD;
             who were clinically diagnosed with ASD confirmed by the ADI-R 7 years ago;&#xD;
&#xD;
          2. their ages range from 10 to 25 (i.e., 3-18 years old at the first assessment);&#xD;
&#xD;
          3. both parents are Han Chinese;&#xD;
&#xD;
          4. who have complete clinical and behavioral data at the 1st assessment;&#xD;
&#xD;
          5. participants and their parents consented to participate in this longitudinal study 7&#xD;
             years ago for complete assessments (3 visits of assessments) at follow-up.&#xD;
&#xD;
        Inclusion Criteria for TD controls, who will be recruited either by school teachers or from&#xD;
        the community, are that they are Han Chinese, consent to the study (if age &lt;18, parents,&#xD;
        too) to complete all the assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For TD controls:&#xD;
&#xD;
          1. comorbidity with DSM-IV-TR or DSM-5 diagnoses of ASD, ADHD, schizophrenia,&#xD;
             schizoaffective disorder, delusional disorder, other psychotic disorder, organic&#xD;
             psychosis, schizotypal personality disorder, bipolar disorder, depression, severe&#xD;
             anxiety disorders or substance use;&#xD;
&#xD;
          2. comorbidity with neurological or systemic disorders; and&#xD;
&#xD;
          3. having a first degree relative who may have ASD based on family history method&#xD;
             assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shur-Fen Gau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital &amp; College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan Univeristy Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233348
org study id: 201403109RINC
nct id: NCT02233348
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Diagnosis of autism
time frame: one day
description: 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.
measure: Diagnosis of autism
time frame: one day
description: Using Autism Diagnostic Observation Scale (ADOS) to assess social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors.
arm group label: ASD group
description: Subjects with DSM-IV ASD diagnosis
arm group label: Control group
description: Controls without lifetime ASD or a family history of ASD
The subjects will receive blood withdrawal. The blood sample will be used for establishing
      lymphoblastoid cell lines, which will be used for molecular genetic experiments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Shur-Fen Gau, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital & College of Medicine
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive