Autism Spectrum DisorderNCT01247662
Psychometric Studies of the Chinese Versions of the SRS, CAST, and AQ
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 2,460 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2011
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive Developmental Disorder. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD or ASD in addition to the above exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Studies of the Chinese Versions of the Social Responsiveness Scale, the Childhood Asperger's Syndrome Test, and the Autism Spectrum Quotient
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.
Read the detailed description
Specific Aims:
- To identify the factor structures and norms of the SRS, CAST, and AQ;
- To assess the concurrent validity of the SRS, CAST, and AQ;
- To assess the discriminative validity of the three scales by testing the difference of total scores and subscales scores of the SRS, CAST, and AQ between the ASD, attention-deficit hyperactivity disorder (ADHD), and control groups;
- To correlate the autistic characteristics between parents and children and compare the magnitude of correlations of autistic traits across the 3 groups.
This is a cross-sectional questionnaire survey in school-based and clinic-based samples. 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. 100 students randomly selected from school-based sample will be reassessed at a 2-week interval for the test-retest reliability study. The teachers will complete the SRS and SNAP-IV (for ADHD symptoms); parents will report on their children on the SCQ, SRS, CAST, SNAP-IV, and CBCL, and report themselves on the SRS, AQ, and ASRI; children will report on themselves using the SRS, AQ, SNAP-IV, and YSR. Parents of clinical participants will be interviewed by the ADI-R or K-SADS-E to confirm their diagnosis of ASD and ADHD, respectively.
We expect that this study will reach the following objectives:
- To establish psychometric properties of the Chinese versions of SRS, CAST, and AQ for future use in clinical, school, and research settings;
- To obtain the preliminary information about the prevalence of ASD, and understand the correlation of autistic traits in family;
- To enhance the awareness of school teachers and counselors about ASD among students.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Social Responsiveness Scale, Childhood Asperger's Syndrome Test, Adult Autism Spectrum Quotient, psychometric
- 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 | Not described | |
| ADHD group | Not described | |
| Normally developing control group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJan 2011
- Study completionDec 2011
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
- Enrolment
- 2,460 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
- NCT01247662
- Sponsor's protocol ID
- 201005041R
- Status last verified
- Apr 2012
- First submitted
- 22 Nov 2010
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Studies of the Chinese Versions of the Social Responsiveness Scale, the Childhood Asperger's Syndrome Test, and the Autism Spectrum Quotient
- ClinicalTrials.gov ID
- NCT01247662
- Acronym / sponsor ID
- 201005041R
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Social Responsiveness Scale, Childhood Asperger's Syndrome Test, Adult Autism Spectrum Quotient, psychometric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,460 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Nov 2010 (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 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.
Detailed description
Specific Aims:
- To identify the factor structures and norms of the SRS, CAST, and AQ;
- To assess the concurrent validity of the SRS, CAST, and AQ;
- To assess the discriminative validity of the three scales by testing the difference of total scores and subscales scores of the SRS, CAST, and AQ between the ASD, attention-deficit hyperactivity disorder (ADHD), and control groups;
- To correlate the autistic characteristics between parents and children and compare the magnitude of correlations of autistic traits across the 3 groups.
This is a cross-sectional questionnaire survey in school-based and clinic-based samples. 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. 100 students randomly selected from school-based sample will be reassessed at a 2-week interval for the test-retest reliability study. The teachers will complete the SRS and SNAP-IV (for ADHD symptoms); parents will report on their children on the SCQ, SRS, CAST, SNAP-IV, and CBCL, and report themselves on the SRS, AQ, and ASRI; children will report on themselves using the SRS, AQ, SNAP-IV, and YSR. Parents of clinical participants will be interviewed by the ADI-R or K-SADS-E to confirm their diagnosis of ASD and ADHD, respectively.
We expect that this study will reach the following objectives:
- To establish psychometric properties of the Chinese versions of SRS, CAST, and AQ for future use in clinical, school, and research settings;
- To obtain the preliminary information about the prevalence of ASD, and understand the correlation of autistic traits in family;
- To enhance the awareness of school teachers and counselors about ASD among students.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | – |
| ADHD group | – | – |
| Normally developing control group | – | – |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive Developmental Disorder. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD or ASD in addition to the above exclusion criteria.
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
Not reported in the source record.
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 15 Nov 2012.
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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 2 inclusion and 1 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 15 Nov 2012. 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.
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 15 Nov 2012.