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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT05738967
Eligibility Criteria:
Inclusion Criteria:
* Child is between the ages of 12-17 at consent/assent.
* The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition).
* The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\>11) and/or the Children's Depression Rating Scale-Revised (\>39).
* Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview
* One parent/guardian is able and willing to participate.
* The parent/guardian is 18 years or older.
* Both parent and child can read and/or understand English.
* Both parent and child reside in Texas.
Exclusion Criteria:
* The child has a diagnosis of psychotic disorder and/or conduct disorder.
* The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care.
* The child has limited verbal communication abilities.
* The child is receiving concurrent psychotherapy for anxiety/depression.
* The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05738967
Study Brief:
Protocol Section:
NCT05738967