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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00620958
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder, including generalized anxiety disorder (GAD), social phobia (SOP), and social anxiety disorder (SAD), as confirmed by ADIS C/P
* Receives a mean score of 4 or greater on the Clinician's Rating Scale of Severity (CSR)
* Willing to stop all other child psychosocial treatment upon study entry
* Comorbid attention deficit hyperactivity disorder (ADHD) and depressive disorders with CSR scores less than 4 are acceptable if treated and stable
* Tics or aggression/impulse control problems with minimal or no impairment are acceptable if treated and stable
* If taking medication, on stable medication treatment for comorbid ADHD, major depressive disorder, tics, or aggression/impulse control
* Agreement of parents or guardians to participate in the child participant's treatment
* Child living with a primary caregiver who has known the child well for at least 6 months and who is legally able to give consent for the child's participation
Exclusion Criteria:
* Meets as a primary diagnosis any Axis I DSM-IV disorder other than GAD, SOP, and SAD
* Child and/or parent meets diagnoses (e.g., primary, secondary, tertiary) for any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, schizophrenia, and other psychotic disorders
* Child and/or parent shows high likelihood and/or serious intent of hurting self or others
* Full-scale IQ score less than 80
* Victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
11 Years
Study:
NCT00620958
Study Brief:
Protocol Section:
NCT00620958