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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT05918393
Eligibility Criteria:
Inclusion Criteria:
* between 5 and 13 years of age
* documented diagnosis of autism spectrum disorder (ASD) or a diagnosis confirmed based on the relevant cutoff score of the Autism Diagnostic Observation Scale (ADOS-2)
* referred for clinical assessment and treatment of severe destructive behavior (SDB; e.g., SIB, aggression) that (a) poses a serious danger to self, others, or the environment, and (b) interferes with the child receiving an appropriate education
* children whose functional analysis results indicate that SDB is maintained by social-negative or social-positive reinforcement will be admitted to this investigation.
Exclusion Criteria:
* severity of their SDB prohibits exposure to baseline conditions
* undergoing changes in their medication regimen
* results of the functional analyses indicate that their SDB is maintained by automatic reinforcement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
13 Years
Study:
NCT05918393
Study Brief:
Protocol Section:
NCT05918393