ASDNCT06155214
Developmental Regression-related Disease Research and Achievement Transformation Innovation Team
An observational study of ASD and GDD, run by Chen Li at 1 site in China.
Trial summary
The incidence rate of developmental regression is gradually increasing. In the early stages of children's development, both ASD and DD patients can experience developmental regression, which in turn aggravates cognitive function impairment and seriously affects the effectiveness of intervention and treatment. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 31 Dec 2024
- 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 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients aged 1-7 who have been diagnosed with autism spectrum disorder and global developmental delay according to DSM-5 by 2 child care physicians and/or psychiatrists with associate senior professional titles or above.
Who may be able to join
- （1）ASD patients：
- Patients diagnosed with autism spectrum disorder based on DSM-5 by 2 child care physicians and/or psychiatrists with associate senior professional titles or above.
- Aged 1-7years
- （2）DDpatients：
- Patients diagnosed with global developmental delay based on DSM-5 by 2 child care physicians and/or psychiatrists with associate senior professional titles or above.
- Aged 1-7 years
Who cannot join
- Exclude other histories of mental illness, neurological diseases and severe physical diseases, exclude patients with a history of substance and drug abuse, and patients who have not taken risperidone and other related antipsychotic drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Growth,Development and Mental Health of Children and Adolescents Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, (+86)13677620103 ext. +86, chenli2012@126.com
About this study
Official title: To Establish Developmental Regression-related Disease Cohort and Animal Model and Achievement Transformation Innovation Team
The incidence rate of developmental regression is gradually increasing. In the early stages of children's development, both ASD and DD patients can experience developmental regression, which in turn aggravates cognitive function impairment and seriously affects the effectiveness of intervention and treatment. However, the mechanism is unclear, and early screening and diagnosis are difficult. At present, the etiological mechanism of regressive autism and retardation patients at home and abroad is still unclear.This study will advance knowledge about the biological neurocognitive processes, clinical course and outcomes with the potential to improve child and family outcomes through earlier recognition and support. Based on the previous research foundation and advantages of team members, this young innovation team intends to further improve early disease screening, diagnosis strategies, and scientific typing plans by conducting basic and clinical collaborative research on the pathogenesis, precise typing biomarkers, and intervention treatment targets of children with major developmental regression related diseases, and to search for possible gene and drug intervention targets.
Read the detailed description
- Procedures. Children who visited the Children's Health Department between 2021.12 and 2024.12., met the inclusion criteria, and had informed consent signed by their parents. Developmental assessment (Gesell assessment, ABC scale) was routinely performed upon enrollment. After enrollment, routine follow-up visits will be conducted every three months for 1-2 hours each time. Clinicians and researchers will carefully sort out the subject's development process, record and evaluate it. If regression occurs, retest developmental assessment (Gesell assessment, ABC questionnaire). Behavioral assessments and blood samples will be collected once for those found to be regressed upon enrollment. The team will conduct biomarker, genomics, and imaging research based on a prospective patient study cohort.
- Sample size.This study is a observational trial. 100 children with autism spectrum disorder who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with regressive autism spectrum disorder. 100 children with global developmental delay who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with global developmental delay.And 100 normally developing children. Tools used in the research process: (Gesell assessment, ABC questionnaire).
- Statistical analysis.All the data are analyzed using SPSS 25.0 or R language,which enters by a dedicated person,and checks by three people to ensure accurate data entry.Statistical analysis is completed under the guidance of professional statistical analysts from the Epidemiology Research Office of the project leader's unit.
- Ethical matters and data protection. Before epidemiological survey,children and guardians participating in the study signed a consent form and schools signed a disclaimer.During the study,medical ethics laws and regulations were strictly observed,and psychiatrists,psychologists and pediatricians participated in the entire process to provide health protection for children.And they protect the privacy of subjects and do not disclose subjects' information.
- Keywords
- ASD, global developmental delay, regression developmental disorder, Third-level talent echelon
- Medical subject headings
- Learning Disabilities
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 |
|---|---|---|
| autism spectrum disorder children | 100 children with autism spectrum disorder who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with regressive autism spectrum disorder. | |
| global developmental delay children | 100 children with global developmental delay who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with regressive global developmental delay. | |
| normally developing children | Included 100 children with normal development. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Gesell Developmental Scale(GDS).
Children are followed up every 6 months, and at each follow-up point, the GDS is used to assess children and obtain their comprehensive scores in various developmental domains. These domains may include motor development, gross and fine motor coordination, language and communication, cognitive and thinking abilities. The score range for language development is 0-100, where a higher score indicates a more excellent level of development in the field, in line with age expectations, while a lower score may indicate a lag or issues in the development of that field.
Measured: 2 years
Changes in Infants-Junior High School Students'Social Development Screening Test.
The scores obtained from the Infant to Middle School Student Social Life Skills Scale (S-M) at each 3-month follow-up reflect the social interaction, communication skills, and adaptation to social environments of the participants at different follow-up stages. The score range for the Infants-Junior High School Students' Social Development Screening Test varies depending on the specific assessment tool used. Generally, the scores may range from 0 to 100 or may be presented in percentile ranks. In general, a higher score indicates that the individual's social development is more advanced and aligned with age expectations. On the other hand, a lower score might suggest developmental lags or challenges in social skills.
Measured: 2 years
Changes in Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
Conducting follow-up assessments every 6 months using the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WISC-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.
Measured: 2 years
Changes in Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) .
Conducting follow-up assessments every 6 months using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WPPSI-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.
Measured: 2 years
Changes in Child Behavior Checklist (CBCL).
Conducting follow-up assessments every 3 months using the Child Behavior Checklist (CBCL) scores reflects the emotional and behavioral issues of children at different follow-up points.The scores on the CBCL typically range from 0 to 100, and higher scores may indicate that children are experiencing difficulties in behavior and emotional problems.
Measured: 2 years
Changes in Questionnaire-Children with Difficulties.
Follow-up assessments every 3 months, using the Questionnaire-Children with Difficulties (QCD) scores, reflect children's psychological issues and behavioral difficulties. The scoring range of the QCD questionnaire may vary depending on the specific version or rating system. For example, certain rating systems may categorize scores into levels of severity such as mild, moderate, or severe difficulties. Higher scores may indicate higher levels of psychological difficulties or disorders. Conversely, lower scores may suggest fewer problems or mild manifestations.
Measured: 2 years
Changes in Dream-Infant-Toddler Language Communication Screening(DREAM-IT-S).
The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) administered at each 3-month follow-up reflect the language abilities of children.The total score range of DREAM-IT-S is between 0 and 10, where a lower score indicates better language communication ability, while a higher score suggests potential delays or obstacles in language development.
Measured: 2 years
Changes in Dreaming Children's Language Standardized Assessment (DREAM-C).
The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) and Dreaming Children's Language Standardized Assessment (DREAM-C) administered at each 3-month follow-up reflect the language abilities of children. The total score range of DREAM-C can vary depending on the specific assessment criteria, but it typically falls within a predetermined range. The exact range depends on the design of the assessment tool and scoring system, but generally, it may be scored on a scale from 0 to 100 or other values. Lower scores indicate stronger language abilities and effective communication skills, while higher scores may suggest potential language development delays or communication barriers.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start30 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Li, Children's Hospital of Chongqing Medical University
- Investigators
- Li Chen, doctor, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155214
- Sponsor's protocol ID
- DRDTIT
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Establish Developmental Regression-related Disease Cohort and Animal Model and Achievement Transformation Innovation Team
- ClinicalTrials.gov ID
- NCT06155214
- Acronym / sponsor ID
- DRDTIT
- Keywords
- ASD, global developmental delay, regression developmental disorder, Third-level talent echelon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chen LiUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Dec 2023 (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.
The incidence rate of developmental regression is gradually increasing. In the early stages of children's development, both ASD and DD patients can experience developmental regression, which in turn aggravates cognitive function impairment and seriously affects the effectiveness of intervention and treatment. However, the mechanism is unclear, and early screening and diagnosis are difficult. At present, the etiological mechanism of regressive autism and retardation patients at home and abroad is still unclear.This study will advance knowledge about the biological neurocognitive processes, clinical course and outcomes with the potential to improve child and family outcomes through earlier recognition and support. Based on the previous research foundation and advantages of team members, this young innovation team intends to further improve early disease screening, diagnosis strategies, and scientific typing plans by conducting basic and clinical collaborative research on the pathogenesis, precise typing biomarkers, and intervention treatment targets of children with major developmental regression related diseases, and to search for possible gene and drug intervention targets.
Detailed description
- Procedures. Children who visited the Children's Health Department between 2021.12 and 2024.12., met the inclusion criteria, and had informed consent signed by their parents. Developmental assessment (Gesell assessment, ABC scale) was routinely performed upon enrollment. After enrollment, routine follow-up visits will be conducted every three months for 1-2 hours each time. Clinicians and researchers will carefully sort out the subject's development process, record and evaluate it. If regression occurs, retest developmental assessment (Gesell assessment, ABC questionnaire). Behavioral assessments and blood samples will be collected once for those found to be regressed upon enrollment. The team will conduct biomarker, genomics, and imaging research based on a prospective patient study cohort.
- Sample size.This study is a observational trial. 100 children with autism spectrum disorder who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with regressive autism spectrum disorder. 100 children with global developmental delay who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with global developmental delay.And 100 normally developing children. Tools used in the research process: (Gesell assessment, ABC questionnaire).
- Statistical analysis.All the data are analyzed using SPSS 25.0 or R language,which enters by a dedicated person,and checks by three people to ensure accurate data entry.Statistical analysis is completed under the guidance of professional statistical analysts from the Epidemiology Research Office of the project leader's unit.
- Ethical matters and data protection. Before epidemiological survey,children and guardians participating in the study signed a consent form and schools signed a disclaimer.During the study,medical ethics laws and regulations were strictly observed,and psychiatrists,psychologists and pediatricians participated in the entire process to provide health protection for children.And they protect the privacy of subjects and do not disclose subjects' information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| autism spectrum disorder children | – | –100 children with autism spectrum disorder who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with regressive autism spectrum disorder. |
| global developmental delay children | – | –100 children with global developmental delay who met the inclusion criteria and signed informed consent forms were included. Among them, there are 30 cases of children with regressive global developmental delay. |
| normally developing children | – | –Included 100 children with normal development. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients aged 1-7 who have been diagnosed with autism spectrum disorder and global developmental delay according to DSM-5 by 2 child care physicians and/or psychiatrists with associate senior professional titles or above.
Key inclusion criteria (6 listed)
- （1）ASD patients：
- （2）DDpatients：
Key exclusion criteria (1 listed)
- Exclude other histories of mental illness, neurological diseases and severe physical diseases, exclude patients with a history of substance and drug abuse, and patients who have not taken risperidone and other related antipsychotic drugs.
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
Changes in the Gesell Developmental Scale(GDS).
Time frame: 2 years
Children are followed up every 6 months, and at each follow-up point, the GDS is used to assess children and obtain their comprehensive scores in various developmental domains. These domains may include motor development, gross and fine motor coordination, language and communication, cognitive and thinking abilities. The score range for language development is 0-100, where a higher score indicates a more excellent level of development in the field, in line with age expectations, while a lower score may indicate a lag or issues in the development of that field.
Changes in Infants-Junior High School Students'Social Development Screening Test.
Time frame: 2 years
The scores obtained from the Infant to Middle School Student Social Life Skills Scale (S-M) at each 3-month follow-up reflect the social interaction, communication skills, and adaptation to social environments of the participants at different follow-up stages. The score range for the Infants-Junior High School Students' Social Development Screening Test varies depending on the specific assessment tool used. Generally, the scores may range from 0 to 100 or may be presented in percentile ranks. In general, a higher score indicates that the individual's social development is more advanced and aligned with age expectations. On the other hand, a lower score might suggest developmental lags or challenges in social skills.
Changes in Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
Time frame: 2 years
Conducting follow-up assessments every 6 months using the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WISC-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.
Changes in Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) .
Time frame: 2 years
Conducting follow-up assessments every 6 months using the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) scores reflect the cognitive and intellectual development of children at different follow-up points. The total score range of WPPSI-IV is in percentage (from 0 to 100), where higher scores indicate stronger abilities in the corresponding domains.
Changes in Child Behavior Checklist (CBCL).
Time frame: 2 years
Conducting follow-up assessments every 3 months using the Child Behavior Checklist (CBCL) scores reflects the emotional and behavioral issues of children at different follow-up points.The scores on the CBCL typically range from 0 to 100, and higher scores may indicate that children are experiencing difficulties in behavior and emotional problems.
Changes in Questionnaire-Children with Difficulties.
Time frame: 2 years
Follow-up assessments every 3 months, using the Questionnaire-Children with Difficulties (QCD) scores, reflect children's psychological issues and behavioral difficulties. The scoring range of the QCD questionnaire may vary depending on the specific version or rating system. For example, certain rating systems may categorize scores into levels of severity such as mild, moderate, or severe difficulties. Higher scores may indicate higher levels of psychological difficulties or disorders. Conversely, lower scores may suggest fewer problems or mild manifestations.
Changes in Dream-Infant-Toddler Language Communication Screening(DREAM-IT-S).
Time frame: 2 years
The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) administered at each 3-month follow-up reflect the language abilities of children.The total score range of DREAM-IT-S is between 0 and 10, where a lower score indicates better language communication ability, while a higher score suggests potential delays or obstacles in language development.
Changes in Dreaming Children's Language Standardized Assessment (DREAM-C).
Time frame: 2 years
The scores obtained from the Dream-Infant-Toddler Language Communication Screening (DREAM-IT-S) and Dreaming Children's Language Standardized Assessment (DREAM-C) administered at each 3-month follow-up reflect the language abilities of children. The total score range of DREAM-C can vary depending on the specific assessment criteria, but it typically falls within a predetermined range. The exact range depends on the design of the assessment tool and scoring system, but generally, it may be scored on a scale from 0 to 100 or other values. Lower scores indicate stronger language abilities and effective communication skills, while higher scores may suggest potential language development delays or communication barriers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No. Data is confidential during the study.
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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.
Li Chen, doctor study director
Children's Hospital of Chongqing Medical University
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 and GDD, run by Chen Li at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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 China. 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 Li Chen, doctor (13677620103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Gesell Developmental Scale(GDS). (time frame: 2 years). The study lists 8 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 4 Dec 2023.