Developmental Regression-related Disease Research and Achievement Transformation Innovation Team

NCT06155214 | Unknown

• 1 other identifier: DRDTIT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ASD; GDD

Keywords

ASD; global developmental delay; regression developmental disorder; Third-level talent echelon

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• （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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Li: lead

Study Sites (1)

Growth,Development and Mental Health of Children and Adolescents Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collect 2ml of venous blood to conduct biomarker, metabolomics, and genomics research.

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Li Chen, doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Li Chen, doctor

CONTACT

13677620103; chenli2012@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor,Director

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 4, 2023
• Study Start: November 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)