Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder

NCT02233348 | Completed DMC

• 1 other identifier: 201403109RINC
• Study Type: observational
• Target: 523
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Diagnosis of autism

  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.

  one day

Secondary Outcomes (1)

• Diagnosis of autism

  one day

Study Arms (2)

ASD group

Subjects with DSM-IV ASD diagnosis

Control group

Controls without lifetime ASD or a family history of ASD

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• ASD participants
• 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;
• their ages range from 10 to 25 (i.e., 3-18 years old at the first assessment);
• both parents are Han Chinese;
• who have complete clinical and behavioral data at the 1st assessment;
• participants and their parents consented to participate in this longitudinal study 7 years ago for complete assessments (3 visits of assessments) at follow-up.

You may not qualify if:

• For TD controls:
• 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;
• comorbidity with neurological or systemic disorders; and
• having a first degree relative who may have ASD based on family history method assessment.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

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

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Susan Shur-Fen Gau, MD, PhD

  National Taiwan University Hospital & College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 8, 2014
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

TW (1)