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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01416805
Eligibility Criteria:
Inclusion Criteria:
* Outpatient boys and girls with an anxiety disorder (see below) aged 7-13 years.
* Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), or social phobia.
* Minimum score of 14 on the PARS Severity Scale.
* The child has a Full Scale IQ greater than 80 as assessed on the Wechsler Abbreviated Scale of Intelligence.
* Have home access to a computer with internet connection.
Exclusion Criteria:
* Receiving concurrent psychotherapy or other counseling services.
* New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment. However, pharmacological interventions may be initiated or added if the child is randomized to the Treatment as Usual arm in Phase II.
* Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the child is on must remain stable during treatment unless s/he is randomized to the Treatment as Usual arm in Phase II.
* (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months.
* Lifetime DSM-IV bipolar disorder, schizophrenia, or schizoaffective disorder.
* Unwillingness of parents to make the commitment to accompany their children for study visits/assessments.
* Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
13 Years
Study:
NCT01416805
Study Brief:
Protocol Section:
NCT01416805