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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT05967468
Eligibility Criteria:
Inclusion Criteria:
* The child is between the ages of 7 to 13 years inclusion at enrollment
* The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
* The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary or co-primary problem as diagnosed using the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
* One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
* The participating parent/guardian lives with their child at least 50% of the time per self-report.
* Both parent and child are able to read and understand English.
* The child has the intellectual and communication skills to engage in CBT, as judged by an experienced supervising clinician.
* Participants must be in the state of Texas for treatment sessions/assessments.
Exclusion Criteria:
* the child has a diagnosis of child lifetime bipolar disorder, drug or alcohol dependence, psychotic disorder, or conduct disorder.
* the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
* the child is receiving concurrent therapy for anxiety.
* New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment OR 6 weeks for an antipsychotic, benzodiazepine, or attention deficit hyperactivity disorder (ADHD) medication before study enrollment. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, antipsychotic) within 4 weeks before study enrollment. Any medications must remain stable during treatment; downward adjustments due to side effects may be acceptable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
13 Years
Study:
NCT05967468
Study Brief:
Protocol Section:
NCT05967468