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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT07245160
Eligibility Criteria:
Inclusion Criteria:
1. Children between the ages of 12-18 years
2. Confirmed diagnosis of ASD that meets DSM-V criteria
3. ADOS scores consistent with an ASD diagnosis
4. WASI scores equivalent to 50-70
5. CBCL with T score \>/= 70 for the anxiety subscale
6. MASC-2/SCARED score with T-scores reflecting clinically significant anxiety
7. Not part of another interventional study or clinical trial
8. Stable non-pharmacological therapies for at least 12 weeks
9. Stable pharmacological therapies for at least 8 weeks
10. Will not start new treatment for anxiety, medication or intervention, within the study 12 week study period
11. Consistent parent partner per child throughout the duration of the study
Exclusion Criteria:
1. Individuals with history of significant suicidal ideations or attempts
2. Individuals involved in a concurrent interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07245160
Study Brief:
Protocol Section:
NCT07245160