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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT06747650
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria:
For adolescents:
* Ages 14-17 years
* Have a diagnosis of FASD under any diagnostic criteria
* Residing in the state of New York
* Willing and able to attend group sessions virtually
* Have one of the following:
1. A diagnosis of disruptive mood dysregulation disorder, borderline personality disorder, or multiple other serious mental health diagnoses
2. A history of multiple psychiatric hospitalizations and/or recurring presentation at psychiatric emergency rooms
3. A score of 7+ on the McLean screening instrument (MSI; instrument attached and included in eligibility screen)
* Have functional deficits in three of five problem areas:
1. Emotional dysregulation
2. Impulsivity (including avoidance)
3. Interpersonal challenges
4. Teenager and family challenges
5. Reduced awareness and focus
* Access to the internet and device with Zoom capabilities
For caregivers:
* Parent or legal guardian of an adolescent (ages 14-17 years) with an FASD diagnosis
* Residing in the state of New York
* Willing and able to attend group sessions virtually
* Access to the internet and device with Zoom capabilities
For clinicians:
* Employee of GVP
* Administered DBT-A to teens with FASD as part of this study
Exclusion Criteria:
* • Adolescent, caregiver, or clinician has insufficient proficiency in English
* Primary psychotic disorder
* Ongoing substance/drug dependence or eating disorder at such a level that would impede engagement with DBT modalities (i.e. if an individual requires detoxification or hospitalization for stabilization)
* Adolescent or caregiver has a moderate to severe intellectual disability (IQ \< 51)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT06747650
Study Brief:
Protocol Section:
NCT06747650