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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT04909658
Eligibility Criteria:
The families were recruited as part of an ongoing research program and tested at our clinical facilities.
Inclusion criteria were based on children characteristics as follows:
* between 3 and 13 years of age;
* clinical diagnosis of ASD based on the DSM-5 criteria from a licensed clinical child neuropsychiatrist;
* DSM-5 severity scores from mild (level 1) to moderate (level 2) in both social communication and restricted interests and repetitive behaviors domains;
* a verbal and performance Developmental Quotient: Griffiths Mental Development Scales, Extended Revised: 2 to 8 years (GMDS-ER 2-8 Luiz et al. 2006) and Wechsler Intelligence Scale for Children (WISC-IV Wechsler D. 2003) above 70;
* no hearing, visual, or physical disabilities that would prevent participation in the intervention;
* not being on psychiatric medication. All children have a previous diagnosis that was further confirmed through the assessment and the consensus of experienced professionals on the research team (i.e., a child neuropsychiatrist and a clinical psychologist).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
13 Years
Study:
NCT04909658
Study Brief:
Protocol Section:
NCT04909658