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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT07024758
Eligibility Criteria:
Inclusion Criteria:
* The child is between the ages of 7 to 17 years inclusive 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 or OCD is the primary or co-primary problem as diagnosed using the DIAMOND-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 can read and understand English.
* The participant has an IQ above 69, based on the KBIT-2, another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team).
* Participants must be in the state of Texas for treatment sessions/assessments.
Exclusion Criteria:
* The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
* The child has significant, current and active suicidality/homicidality and/or self-injury requiring medical intervention.
* The child has limited verbal communication abilities (e.g., no independent verbal communication).
* The child is receiving concurrent psychotherapy with anxiety and/or OCD as the primary focus. They can pause ongoing therapy to enroll.
* The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
* The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
* The child requires a higher level of care than can be provided through the study (e.g., significant, current suicidal ideation).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT07024758
Study Brief:
Protocol Section:
NCT07024758