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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT05790668
Eligibility Criteria:
Inclusion Criteria:
* boys and girls from ages 3 to 17
* destructive behavior that occurs at least 10 times a day, despite previous treatment
* destructive behavior reinforced by social consequences
* stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment
* on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free
* stable educational plan and placement with no anticipated changes during the child's treatment
Exclusion Criteria:
* patients who do not meet the inclusion criteria
* patients currently receiving 15 or more hours per week of treatment for their destructive behavior
* Diagnostic and Statistical Manual-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism)
* a comorbid health condition or major mental disorder that would interfere with study participation
* occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on routine clinical-risk assessment
* patients requiring changes to protective supports for self-injury or drug treatment, but investigators will invite these patients to participate when protective supports and drug regimen are stable
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT05790668
Study Brief:
Protocol Section:
NCT05790668