Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT05531669
Eligibility Criteria:
Inclusion Criteria:
1. Age of 18 months to 6 years old at the time of enrollment, no gender requirement;
2. Children who were diagnosed with autism spectrum disorder in 5 research centers, meet the diagnostic criteria by Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), and the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2).
3. Complete pre-assessments in outpatient clinics, including: Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Social Communication Questionnaire (SCQ), Child Autism Rating Scale (CARS), Gesell Developmental Schedules (GDS) for children; Raven's Standard Progressive Matrices (SPM), Hamilton Depression Scale (HAMD) and Parenting Stress Index-Short Form (PSI-SF) for parents.
4. Parents agreed to participate in the study provided written informed consent at recruitment.
Exclusion Criteria:
1. High functioning ASD children with abnormal social communication but high language level. Language development quotient\>85 in GDS;
2. Suffering from:
1. hereditary diseases, such as Rett syndrome, Fragile X syndrome, trisomy 21 or tuberous sclerosis;
2. abnormal vision or hearing impairment;
3. movement disorders, such as cerebral palsy;
4. epilepsy;
3. Receive 7 hours or more per week of 1:1 intensive intervention, such as Applied Behavior Analysis (ABA), Parent-Implemented Language training, etc.
4. Parents scoring \<90 by SPM, or report being severely depressed by HAMD, will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
6 Years
Study:
NCT05531669
Study Brief:
Protocol Section:
NCT05531669