Autism Spectrum DisorderNCT02233348
Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- Type of treatment
- Injection or infusion
- How many people
- 523 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder: a Follow-up Study
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.
Read the 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:
- 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.
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | Subjects with DSM-IV ASD diagnosis | |
| Control group | Controls without lifetime ASD or a family history of ASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (1)
Diagnosis of autism
Using Autism Diagnostic Observation Scale (ADOS) to assess social communication, social relatedness, play, imaginative of materials, and restricted and/or repetitive behaviors.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233348
- Sponsor's protocol ID
- 201403109RINC
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2014
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Psychosocial Outcome of Youths With Autism Spectrum Disorder: a Follow-up Study
- ClinicalTrials.gov ID
- NCT02233348
- Acronym / sponsor ID
- 201403109RINC
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | –Subjects with DSM-IV ASD diagnosis |
| Control group | – | –Controls without lifetime ASD or a family history of ASD |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Diagnosis of autism
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shur-Fen Gau, MD, PhD principal investigator
National Taiwan University Hospital & College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of autism (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.