Clinical, Environmental, Neurocognitive, Brain Imaging, and Genetic Validity of Autism and ADHD

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00916851
Collaborator
(none)
300
1
36
8.3

Study Details

Study Description

Brief Summary

The behavioral patterns, neurocognitive and social impairments, and high heritability are the common characteristics of autism spectrum disorders (ASD) and attention-deficit hyperactivity disorder (ADHD), the two most common early-onset neuropsychiatric disorders. Little is known about the discriminative validity between these two disorders. As brain imaging studies have been recognized as an important biological tool to validate disease involving the brain, no studies have employed this approach to distinguish the brain functioning between ASD and ADHD. Moreover, there is lack of comprehensive data of environmental, behavioral, neurocognitive, neuroimaging, and genetic data for healthy children. Hence, we propose this program project involving expertise researchers in the fields of child psychiatry and psychology, psychiatric genetics, and brain imaging studies to elucidate the neuropathophysiology and genes & environment interactions of ASD and ADHD as comparing to healthy controls by integrating data from environments, behavioral phenotypes, endophenotypes, and genotypes in one study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Specific Aims:
    1. To compare the individual phenotypes (emotion/behaviors, attention, impulsivity, etc.), endophenotypes (neurocognitive and social cognitive function, brain imaging), and genotypes, and growing environments (prenatal and developmental history, family, school, and social functions) among ASD, ADHD, and normal children to search for etiologies and developmental psychopathologies for ASD and ADHD and to test the discriminative validity of /between ASD and ADHD; and

    2. To examine whether the correlations and interactions among/within behavioral phenotypes, endophenotypes, genotypes, and environments vary across the three groups.

    This 3-year program project consists of three projects investigating a sample, aged 8-17 years, of 100ASD, 100ADHD, and 100 normally developing children and adolescents.

    1. Using diagnostic interviews, observation, self-administered questionnaires, social cognitive tests (emotion recognition test, mentalizing test) and neurocognitive tests (CANTAB, CPT, WCST, WISC-III-R, Émbedded Figure Test, Global-local Perception Test), we will collect data from 300 subjects (100 for each group) regarding individual (phenotype & endophenotype) and growing environments.

    2. Using Diffusion Spectrum Imaging, resting-state functional MRI (fMRI), cognitive fMRI (fMRI- semantic association test, fMRI-stroop test), and template, we will collect brain imaging data from 90 subjects regarding individual endophenotype.

    3. We will collect the blood samples to establish the cell lines and to conduct SNP genotyping, haplotype, and copy number variation analysis.

    With accomplishment of this project, we will not only establish the genotypes for phenotype and endophenotype of general characteristics and assist identifying pathogenesis of ASD and ADHD, but also contribute the etiological studies on several adult psychiatric disorders in future prospective follow-up of this cohort.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Clinical, Environmental, Neurocognitive, Brain Imaging, and Genetic Validity of Autism and Attention-deficit Hyperactivity Disorder
    Actual Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Jul 31, 2013
    Actual Study Completion Date :
    Jul 31, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Control group

    Normally developing children and adolescents

    ADHD group

    Children and adolescents with ADHD

    ASD group

    Children and adolescents with ASD

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      8 Years to 17 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Control group: Subjects without ADHD or ASD; ADHD group & ASD group: subjects have a clinical diagnosis of ADHD, or ASD defined by the DSM-IV, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits.

      • Ages range from 7 to 18 when we conduct the study.

      • Subjects have at least one biological parent.

      • Both parents are Han Chinese.

      • subjects and their biological parents (and siblings if any) consent to participate in this study for complete phenotype assessments and blood withdraw for genetic study

      Exclusion Criteria:
      • The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive Developmental Disorder. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD or ASD in addition to the above exclusion criteria.

      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:
      NCT00916851
      Other Study ID Numbers:
      • 200903062R
      First Posted:
      Jun 10, 2009
      Last Update Posted:
      Sep 2, 2021
      Last Verified:
      Sep 1, 2021

      Study Results

      No Results Posted as of Sep 2, 2021