ASDNCT06339359
A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders
An observational study of ASD, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis. Read more about this study
- Who is it for?
- Ages Up to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- ASD
- What is being tested?
- Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2024to 31 Mar 2025
- 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 Up to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adolescents volunteers
Who may be able to join
- Children and adolescents under the age of 19 at the time of registration
- A person whose legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after receiving a detailed explanation of this study and fully understanding it
Who cannot join
- Those with abnormalities in hearing and vision
- Those who are likely to have difficulty participating in the study according to the judgment of the clinical investigator
- If the visits set out in this research plan are not followed or the patient's guardian does not cooperate due to low understanding of the patient.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
Minyoung Kim, M.D., Ph.D., 82-31-780-1872, kmin@cha.ac.kr
About this study
This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.
Read the detailed description
This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.
- Conditions
- ASD
- Being tested
- Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessmentsOther
Collection of clinical data including K-Bayley Scales of Infant and Toddler Development Third Edition (K-BSID-Ⅲ), , Beery-Buktenica Visual-Motor Integration, Sixth Edition (VMI-6) and clinical measurement. motor analysis and eye tracking
What is being measured
The primary outcome is the main question the study is designed to answer.
K-BSID-Ⅲ
Measurement of K-BSID-Ⅲ is a developmental test administered to infants from 16 days old to 42 months old, and consists of 16 subtests measuring a total of 5 development areas (cognitive, language, motor, social-emotional, and adaptive behavior).
Measured: Between March 2024 and March 2025
ADI-R
Measurement of ADI-R is a test conducted to screen autism spectrum disorder from other developmental disabilities in children with a mental age of 2 years or older, and is conducted through a structured interview with the primary caregiver.
Measured: Between March 2024 and March 2025
M-CHAT
Measurement of M-CHAT is a tool to screen the risk level of autism spectrum disorder in children aged 16 to 30 months and is evaluated based on the primary caregiver's report.
Measured: Between March 2024 and March 2025
ADOS-2
Measurement of ADOS-2 is a standardized assessment tool that evaluates social interaction and stereotyped and repetitive behavior in people suspected of having autism spectrum disorder.
Measured: Between March 2024 and March 2025
K-WPPSI-Ⅳ
Measurement of K-WPPSI-Ⅳ is an intelligence test to evaluate cognitive function in children aged 2 years and 6 months to 7 years and 7 months.
Measured: Between March 2024 and March 2025
K-CARS-2
Measurement of K-CARS-2 is an one of the most widely used tools for the purpose of distinguishing autism from other developmental disabilities and the degree of autism.
Measured: Between March 2024 and March 2025
CBCL
Measurement of CBCL is a useful clinical tool used in many countries around the world to evaluate social adaptation and emotional behavior problems in children and adolescents.
Measured: Between March 2024 and March 2025
SCQ
Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report.
Measured: Between March 2024 and March 2025
GMFM
Measurement of GMFM is a standardized observational evaluation tool with validity that measures changes in gross motor function over time in children with cerebral palsy.
Measured: Between March 2024 and March 2025
HFT
Measurement of HFT is a tool to evaluate the degree of development of hand function according to age, forward arm reaching, various grasping abilities, coordination ability between both hands, and object handling ability.
Measured: Between March 2024 and March 2025
BOT-2
Measurement of BOT-2 is a testing tool used for movement training evaluation and development.
Measured: Between March 2024 and March 2025
VMI-6
Measurement of VMI-6 is a test that validly measures the visual-motor integration ability, visual perception ability, and motor coordination ability of various age groups from infants to adults.
Measured: Between March 2024 and March 2025
SP
Measurement of SP is a standardized tool for assessing children's sensory processing patterns in the context of everyday life, providing unique information about how sensory processing supports or hinders participation.
Measured: Between March 2024 and March 2025
Eye Tracking
While the subject watches the video material being played, gaze and behavioral data are recorded.
Measured: Between March 2024 and March 2025
Motion Analysis
Measurement of Motion analysis is an evaluation process of the research subject is filmed while administering ADOS and RBS-EC.
Measured: Between March 2024 and March 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339359
- Sponsor's protocol ID
- 2024-02-014
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06339359
- Acronym / sponsor ID
- 2024-02-014
- Conditions
- ASD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- 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.
This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.
Detailed description
This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents volunteers
Key inclusion criteria (2 listed)
- Children and adolescents under the age of 19 at the time of registration
- A person whose legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after receiving a detailed explanation of this study and fully understanding it
Key exclusion criteria (3 listed)
- Those with abnormalities in hearing and vision
- Those who are likely to have difficulty participating in the study according to the judgment of the clinical investigator
- If the visits set out in this research plan are not followed or the patient's guardian does not cooperate due to low understanding of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessmentsCollection of clinical data including K-Bayley Scales of Infant and Toddler Development Third Edition (K-BSID-Ⅲ), , Beery-Buktenica Visual-Motor Integration, Sixth Edition (VMI-6) and clinical measurement. motor analysis and eye tracking | Other | – |
Primary outcome
K-BSID-Ⅲ
Time frame: Between March 2024 and March 2025
Measurement of K-BSID-Ⅲ is a developmental test administered to infants from 16 days old to 42 months old, and consists of 16 subtests measuring a total of 5 development areas (cognitive, language, motor, social-emotional, and adaptive behavior).
ADI-R
Time frame: Between March 2024 and March 2025
Measurement of ADI-R is a test conducted to screen autism spectrum disorder from other developmental disabilities in children with a mental age of 2 years or older, and is conducted through a structured interview with the primary caregiver.
M-CHAT
Time frame: Between March 2024 and March 2025
Measurement of M-CHAT is a tool to screen the risk level of autism spectrum disorder in children aged 16 to 30 months and is evaluated based on the primary caregiver's report.
ADOS-2
Time frame: Between March 2024 and March 2025
Measurement of ADOS-2 is a standardized assessment tool that evaluates social interaction and stereotyped and repetitive behavior in people suspected of having autism spectrum disorder.
K-WPPSI-Ⅳ
Time frame: Between March 2024 and March 2025
Measurement of K-WPPSI-Ⅳ is an intelligence test to evaluate cognitive function in children aged 2 years and 6 months to 7 years and 7 months.
K-CARS-2
Time frame: Between March 2024 and March 2025
Measurement of K-CARS-2 is an one of the most widely used tools for the purpose of distinguishing autism from other developmental disabilities and the degree of autism.
CBCL
Time frame: Between March 2024 and March 2025
Measurement of CBCL is a useful clinical tool used in many countries around the world to evaluate social adaptation and emotional behavior problems in children and adolescents.
SCQ
Time frame: Between March 2024 and March 2025
Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report.
GMFM
Time frame: Between March 2024 and March 2025
Measurement of GMFM is a standardized observational evaluation tool with validity that measures changes in gross motor function over time in children with cerebral palsy.
HFT
Time frame: Between March 2024 and March 2025
Measurement of HFT is a tool to evaluate the degree of development of hand function according to age, forward arm reaching, various grasping abilities, coordination ability between both hands, and object handling ability.
BOT-2
Time frame: Between March 2024 and March 2025
Measurement of BOT-2 is a testing tool used for movement training evaluation and development.
VMI-6
Time frame: Between March 2024 and March 2025
Measurement of VMI-6 is a test that validly measures the visual-motor integration ability, visual perception ability, and motor coordination ability of various age groups from infants to adults.
SP
Time frame: Between March 2024 and March 2025
Measurement of SP is a standardized tool for assessing children's sensory processing patterns in the context of everyday life, providing unique information about how sensory processing supports or hinders participation.
Eye Tracking
Time frame: Between March 2024 and March 2025
While the subject watches the video material being played, gaze and behavioral data are recorded.
Motion Analysis
Time frame: Between March 2024 and March 2025
Measurement of Motion analysis is an evaluation process of the research subject is filmed while administering ADOS and RBS-EC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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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.
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 ASD, run by Bundang CHA Hospital at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim MinYoung (82-31-780-6281, kmin@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-BSID-Ⅲ (time frame: Between March 2024 and March 2025). The study lists 15 primary outcomes in all. 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 1 Apr 2024.