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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00916851
First received: June 8, 2009
Last updated: July 8, 2012
Last verified: April 2012
  Purpose

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
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Clinical, Environmental, Neurocognitive, Brain Imaging, and Genetic Validity of Autism and Attention-deficit Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Groups/Cohorts
Control group
Normally developing children and adolescents
ADHD group
Children and adolescents with ADHD
ASD group
Children and adolescents with ASD

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916851

Contacts
Contact: Susan Shur-Fen Gau, MD, PhD 886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD    886-2-23123456 ext 66802    gaushufe@ntu.edu.tw   
Principal Investigator: Susan Shur-Fen Gau, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital & College of Medicine
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00916851     History of Changes
Other Study ID Numbers: 200903062R
Study First Received: June 8, 2009
Last Updated: July 8, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
attention-deficit hyperactivity disorder
autism spectrum disorders
normally developing children and adolescents
cognitive functions
emotion/behaviors
brain imaging
genotypes

Additional relevant MeSH terms:
Autistic Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014