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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT07024303
Eligibility Criteria:
The adult subjects will be the caregiver/guardian of the minor subjects. The only inclusion criterion for the adult subjects is that they must be the caregiver/legal guardian of the minor subject and their home is primarily English speaking.
The minor subjects will be individuals who were referred to Child and Adolescent Psychiatry at University of Iowa Healthcare for management of challenging behavior (e.g., physical aggression, self-injury, destruction, elopement, generalized refusal) and meet the following criteria:
1. Between the ages of 2 years, 0 months and 12 years, 0 months
2. Diagnosed with autism spectrum disorder
3. Diagnosed with intellectual disability at the moderate, severe, or profound range (called "profound autism").
4. Display challenging behavior, including one or more of the following: physical aggression, self-injury, destruction, elopement, generalized refusal
5. Live in a home where English is the primary language spoken.
6. The caregiver is considering medication, behavioral therapy, or both to treat the child's challenging behavior.
Subjects would be excluded if:
1. Not diagnosed with autism spectrum disorder
2. Do not have a moderate or severe/profound intellectual disability
3. Do not display challenging behavior
4. Live in a home where English is not the primary language spoken
5. Caregivers are not considering medication, behavior therapy, or both to treat challenging behavior
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT07024303
Study Brief:
Protocol Section:
NCT07024303