NCT02720588

Brief Summary

Specific Aims: This study aims to examine the hypothesis that individuals with Autism spectrum disorder (ASD) and their unaffected siblings shared alterations in gray and white matter volume and their associated intrinsic functional connectivity, to build upon limited literature about neuroimaging endophenotypes of ASD. The investigators also aim to test whether these shared differences are associated with behavioral autistic traits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

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

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

March 22, 2016

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychiatric Interview

    Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)

    1 hour

Study Arms (3)

ASD group

Subjects have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV criteria

Sibling group

Sex-matched unaffected siblings of ASD probands

TD group

Typically developing controls without lifetime ASD or a family history of ASD

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample consists of 30 adults with ASD, and 30 sex-matched unaffected siblings, and 30 healthy volunteers.

You may qualify if:

  • \. Subjects who have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV criteria

You may not qualify if:

  • Systemic medical illness
  • Current symptoms or lifetime history of DSM-5 diagnosis of mood disorder, any psychotic disorder, substance use disorder, learning disorder, anxiety disorder, claustrophobia, obsessive compulsive disorder, or mental retardation.
  • With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy;
  • Full-scale IQ \< 70.

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

  • Hsiang-Yuan Lin, MD

    Dept of Psychiatry, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR
  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 28, 2016

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations