Research on developmental regression in children with autism and global developmental delay
To Establish Developmental Regression-related Disease Cohort and Animal Model and Achievement Transformation Innovation Team
This study is testing how developmental regression affects children with autism and global developmental delay to help improve early diagnosis and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing) |
| Trial ID | NCT06155214 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms behind developmental regression in children diagnosed with autism spectrum disorder (ASD) and global developmental delay (GDD). It will involve a cohort of 100 children with ASD, 100 with GDD, and 100 normally developing children, who will undergo developmental assessments and follow-up evaluations every three months. The study will collect behavioral assessments and blood samples to explore biomarkers, genomics, and imaging related to these conditions. The goal is to enhance early screening, diagnosis, and intervention strategies for affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-7 years diagnosed with autism spectrum disorder or global developmental delay.
Not a fit: Patients with other mental illnesses, neurological diseases, severe physical diseases, or those with a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved early recognition and support for children experiencing developmental regression, ultimately enhancing their cognitive and developmental outcomes.
How similar studies have performed: While the mechanisms of developmental regression are still unclear, previous studies have explored related areas, indicating potential for success in understanding and addressing these conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * （1）ASD patients： 1. 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. 2. Aged 1-7years * （2）DDpatients： 1. 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. 2. Aged 1-7 years Exclusion Criteria: * 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.
Where this trial is running
Chongqing, Chongqing
- Growth,Development and Mental Health of Children and Adolescents Center — Chongqing, Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Li Chen, doctor
- Email: chenli2012@126.com
- Phone: 13677620103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.