Autism Spectrum DisorderNCT02719067
A Longitudinal Follow-up Imaging Study on Children and Adolescents With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The significance of this project is the first longitudinal study to investigate the changes of neurocognitive functions of children and adolescents with ASD and to identify the potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging technique (Tract-based automatic analysis, TBAA… Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Autism Spectrum Disorder
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 70 ASDs, aged 12-20, from the cohort of ASD established by previous imaging studies supported by National Science Council(NSC),Taiwan (now Ministry of Science and Technology, MOST), who consented to this follow-up study at their first assessments in 2010-2014 and 70 age-, and sex-matched TD.
Who may be able to join
- ASD group:
- 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 3-5 years ago
- ages range from 12 to 20 (i.e., 7-17 years old at the first assessment)
- both parents are Han Chinese
- have complete clinical and behavioral data at the 1st assessment
- participants and their parents consented to participate in this longitudinal study 3-5 years ago for complete assessments at follow-up.
Show all 9Show fewer
- TD group:
- ages range from 12 to 20
- both parents are Han Chinese
Who cannot join
- 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
- 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
The significance of this project is the first longitudinal study to investigate the changes of neurocognitive functions of children and adolescents with ASD and to identify the potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition to single-echo resting-state fMRI). The success of this project will fill the gap of our understanding of longitudinal changes of brain function by neuropsychological and imaging approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of translational research in ASD.
Read the detailed description
Autism spectrum disorder (ASD) is a common severe, clinically and genetically heterogeneous childhood-onset neurodevelopmental disorder. Due to its high prevalence, typical autistic symptoms, and severe lifelong impairment without effective prevention and treatment, the developmental change of brain functions in individuals with this study has been recognized as one of the key topics of ASD. The goal of this project is to prospectively investigate the stability and changes of brain functions assessed by neuropsychological tests and neuroimages in a cohort of children and adolescents with ASD who had the first assessment 3-5 years ago.
Specific Aims: To investigate the stability and changes of neuropsychological and structural and functional connectivity among children and adolescents with ASD as compared to age- and sex-matched typically developing (TD) controls; and to identify predictors for these neurocognitive changes across a 3-5 follow-up period.
The investigators will prospectively follow up 70 ASDs and 70 TDs for reassessments of clinical symptoms, neuropsychological functions, and structural and functional brain connectivity. The assessments include ASD symptoms (ASD only: Autism Diagnostic Interview-Revised, Autism Diagnostic Observation Scale; all: Social Responsiveness Scale (SRS), Social Communication Questionnaires (SCQ), Autism Spectrum Quotient (AQ)), other psychiatric disorders (The Chinese version of the Kiddie Schedule of Schizophrenia and Affective Disorder Scale-Epidemiologic version, K-SADS-E), neuropsychological functions (Conner's Continuous Performance Test) and MRI assessments (T1 and T2 templates, Diffusion Spectrum Imaging, resting-state fMRI).
- Conditions
- Autism Spectrum Disorder
- Keywords
- neuropsychological function, neuroimage, developmental changes
- 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 have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV and ICD-10 criteria | |
| TD group | Typically developing 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.
Structural neuroimaging
Using diffusing spectrum imaging (DSI) to assess the structural connectivity in brain circuitries
Measured: 2 hours
Secondary outcomes (1)
Neuropsychological functions
Conner's Continuous Performance Test (CCPT) is used to assess the sustained attention, cognitive controls, and vigilance
Measured: 0.5 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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
- 140 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
- NCT02719067
- Sponsor's protocol ID
- 201602058RIN
- Status last verified
- Sep 2021
- First submitted
- 10 Mar 2016
- 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
- A Longitudinal Follow-up Imaging Study on Children and Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02719067
- Acronym / sponsor ID
- 201602058RIN
- Conditions
- Autism Spectrum Disorder
- Keywords
- neuropsychological function, neuroimage, developmental changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 25 Mar 2016 (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.
The significance of this project is the first longitudinal study to investigate the changes of neurocognitive functions of children and adolescents with ASD and to identify the potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition to single-echo resting-state fMRI). The success of this project will fill the gap of our understanding of longitudinal changes of brain function by neuropsychological and imaging approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of translational research in ASD.
Detailed description
Autism spectrum disorder (ASD) is a common severe, clinically and genetically heterogeneous childhood-onset neurodevelopmental disorder. Due to its high prevalence, typical autistic symptoms, and severe lifelong impairment without effective prevention and treatment, the developmental change of brain functions in individuals with this study has been recognized as one of the key topics of ASD. The goal of this project is to prospectively investigate the stability and changes of brain functions assessed by neuropsychological tests and neuroimages in a cohort of children and adolescents with ASD who had the first assessment 3-5 years ago.
Specific Aims: To investigate the stability and changes of neuropsychological and structural and functional connectivity among children and adolescents with ASD as compared to age- and sex-matched typically developing (TD) controls; and to identify predictors for these neurocognitive changes across a 3-5 follow-up period.
The investigators will prospectively follow up 70 ASDs and 70 TDs for reassessments of clinical symptoms, neuropsychological functions, and structural and functional brain connectivity. The assessments include ASD symptoms (ASD only: Autism Diagnostic Interview-Revised, Autism Diagnostic Observation Scale; all: Social Responsiveness Scale (SRS), Social Communication Questionnaires (SCQ), Autism Spectrum Quotient (AQ)), other psychiatric disorders (The Chinese version of the Kiddie Schedule of Schizophrenia and Affective Disorder Scale-Epidemiologic version, K-SADS-E), neuropsychological functions (Conner's Continuous Performance Test) and MRI assessments (T1 and T2 templates, Diffusion Spectrum Imaging, resting-state fMRI).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | –Subjects have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV and ICD-10 criteria |
| TD group | – | –Typically developing controls without lifetime ASD or a family history of ASD |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 70 ASDs, aged 12-20, from the cohort of ASD established by previous imaging studies supported by National Science Council(NSC),Taiwan (now Ministry of Science and Technology, MOST), who consented to this follow-up study at their first assessments in 2010-2014 and 70 age-, and sex-matched TD.
Key inclusion criteria (9 listed)
- 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 3-5 years ago
- ages range from 12 to 20 (i.e., 7-17 years old at the first assessment)
- both parents are Han Chinese
- have complete clinical and behavioral data at the 1st assessment
- participants and their parents consented to participate in this longitudinal study 3-5 years ago for complete assessments at follow-up.
Key exclusion criteria (3 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
- 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
Structural neuroimaging
Time frame: 2 hours
Using diffusing spectrum imaging (DSI) to assess the structural connectivity in brain circuitries
1 secondary outcome
Neuropsychological functions
Time frame: 0.5 hour
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.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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 9 inclusion and 3 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?
Structural neuroimaging (time frame: 2 hours). 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.