NCT01247662

Brief Summary

Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder with prominent reciprocal social and communication impairment and restricted repetitive behavior or interest. ASD is a highly heritable disease with tremendous impact on individuals, families, and society. In addition to the interview instruments, self-administered rating scales are commonly used in screening, assessment of symptoms' change, and evaluation of intervention effects. The Social Responsiveness Scale, the Childhood Asperger's Syndrome Test, and the Autism Spectrum Quotient are internationally widely used rating scales measuring autistic traits in both clinical and community samples in western counties. Establishment of internationally-recognized reliable and valid instruments is not only useful for clinical screening, but also helpful in future functional outcomes, neurocognitive, genetic and brain imaging studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 15, 2012

Status Verified

April 1, 2012

First QC Date

November 22, 2010

Last Update Submit

November 14, 2012

Conditions

Keywords

Autism spectrum disorderSocial Responsiveness ScaleChildhood Asperger's Syndrome TestAdult Autism Spectrum Quotientpsychometric

Study Arms (3)

ASD group

ADHD group

Normally developing control group

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The participants include (1) ASD group: 200 cases with DSM-IV ASD; (2) ADHD group: 200 cases with DSM-IV ADHD; (3) Normally developing control group: a school-based sample of around 1200 grade 1 to grade 8 students.

You may qualify if:

  • Control group: Subjects without ADHD or ASD;
  • ADHD group \& ASD group: subjects have a clinical diagnosis of ADHD, or ASD defined by the Diagnostic and Statistical Manual, Fourth Edition (DSM-IV), which was made by a full-time board-certificated child psychiatrist at the first visit and following visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 24, 2010

Study Start

January 1, 2011

Study Completion

December 1, 2011

Last Updated

November 15, 2012

Record last verified: 2012-04

Locations