Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02233348
Recruitment Status : Recruiting
First Posted : September 8, 2014
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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
Autism Spectrum Disorder

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.

Layout table for study information
Study Type : Observational
Estimated 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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
ASD group
Subjects with DSM-IV ASD diagnosis
Control group
Controls without lifetime ASD or a family history of ASD



Primary Outcome Measures :
  1. Diagnosis of autism [ Time Frame: 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 [ Time Frame: one day ]
    Using Autism Diagnostic Observation Scale (ADOS) to assess social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors.


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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
373 ASD, aged 10-25, from the cohort of ASD established by NRPGM, who consented to this follow-up study at their first assessments in 2007-2011 and 150 age-, and sex-matched TD, at the ratio of 2:1.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233348


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

Locations
Layout table for location information
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 Gau, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital & College of Medicine

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02233348     History of Changes
Other Study ID Numbers: 201403109RINC
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders