Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT02233348|
Recruitment Status : Recruiting
First Posted : September 8, 2014
Last Update Posted : March 15, 2016
|Condition or disease|
|Autism Spectrum Disorder|
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.
- 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.
- 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.
- 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.
- To correlate the data from structural and functional connectivity, neuropsychology and ASD core symptoms stratifying by proband-unaffected sibling dyads, and different developmental stages.
- To collect blood sample, and to analyze neurodevelopmental and immune genes, cytokine level, and environmental exposure.
|Study Type :||Observational|
|Estimated Enrollment :||523 participants|
|Observational Model:||Case Control|
|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|
Subjects with DSM-IV ASD diagnosis
Controls without lifetime ASD or a family history of ASD
- 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.
- 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
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
|Contact: Susan Shur-Fen Gau, MD, PhD||886-2-23123456 ext email@example.com|
|National Taiwan Univeristy Hospital||Recruiting|
|Contact: Susan Shur-Fen Gau, MD, PhD 886-2-23123456 ext 66802 firstname.lastname@example.org|
|Principal Investigator: Susan Shur-Fen Gau Gau, MD, PhD|
|Principal Investigator:||Susan Shur-Fen Gau, MD, PhD||National Taiwan University Hospital & College of Medicine|