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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT04666493
Eligibility Criteria:
Inclusion Criteria:
1. Chronological age between 8 and 13 years (13 yr, 11 mos, 29 days)
2. Have a clinical diagnosis of Autism Spectrum Disorder (ASD)
3. Ability to read at a grade 2 level or above (based on parent report)
4. Verbally fluent at a grade 2 level or above (can speak or respond to questions that are appropriate for a child in grade 2; based on parent report)
5. Child with significant anxiety symptoms as determined by the clinical team
6. To enhance generalizability of our findings, children will be eligible if they present with some other co-morbid psychiatric conditions (see exclusion criteria)
7. If already receiving pharmacological interventions, must meet the following criteria: If receiving concomitant medications for anxiety, must be on a stable dose during the month prior to screening (6 weeks for fluoxetine).
Exclusion Criteria:
1. Being currently enrolled in another active behavioral/ educational/ psychological treatment for anxiety
2. Diagnosis of acute psychosis or conduct disorder, or a primary diagnosis of Obsessive Compulsive Disorder without another anxiety diagnosis or clinically significant level of anxiety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
13 Years
Study:
NCT04666493
Study Brief:
Protocol Section:
NCT04666493