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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT07219992
Eligibility Criteria:
Inclusion Criteria:
* Meet criteria for a primary DSM-5 AD, including separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, specific phobia, panic disorder, and agoraphobia (determined by the ADIS-C/P).
* Cease all other psychosocial treatment, upon consultation with the project staff and service provider.
* Not currently use any psychotropic medication, other than a stable dose (i.e., same dose for a minimum of 6 months prior to enrollment; no changes during course of the study) of a stimulant medication or selective serotonin reuptake inhibitor (SSRI).
* Have an eligible and willing participating parent (see parent exclusions below).
Exclusion Criteria:
Adolescent:
* Meet criteria for any DSM-5 disorder more impairing than the most impairing AD (determined by the ADIS-C/P).
* Have any of the following disorders: autism spectrum disorder; intellectual disability; neurocognitive disorders; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders (determined by the Health History Form and ADIS-C/P).
* Report a suicide attempt in the last 3 months, or current suicide intent and plans (determined by the ASQ).
* Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services.
* Not have sufficient proficiency with the English language to complete assessments.
Parents:
* Have any of the following: intellectual disability; neurocognitive disorders; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders (determined by the Health History Form).
* Not be living with the adolescent at least 50% of the time for at least one year prior to enrollment.
* Not have sufficient proficiency with the English language to complete assessments and treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT07219992
Study Brief:
Protocol Section:
NCT07219992