Dialectical Behavior Therapy for Adolescents With Fetal Alcohol Spectrum Disorders Feasibility Trial

Completed · Not applicable

Conditions studied: Fetal Alcohol Spectrum Disorder

In brief

The purpose of this study is to test the feasibility of dialectical behavior therapy for adolescents (DBT-A) with fetal alcohol spectrum disorders (FASD). In partnership with a community mental health practice, Genesee Valley Psychology (GVP), two cohorts of five adolescents with FASD and their caregivers will participate in an already existing comprehensive DBT-A program (including individual therapy, group skills training, and 24/7 phone coaching). This program has been adapted for neurodivergent teens, including the development of trainings for mental health clinicians on FASD. The aim of the current study is to assess the acceptability of DBT-A from the perspective of teens, caregivers, and clinicians. Additionally, barriers and facilitators of implementing DBT-A with teens with FASD, as well as the feasibility of the research protocol will be assessed to inform later larger-scale trials.

Key facts

Study ID

NCT06747650

Run by

University of Rochester

People needed

9

Starts

2024-12-24

Expected to finish

2025-10-29

Last updated by the study team

2026-02-05

Who can join

Age: 14 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• A diagnosis of disruptive mood dysregulation disorder, borderline personality disorder, or multiple other serious mental health diagnoses
• A history of multiple psychiatric hospitalizations and/or recurring presentation at psychiatric emergency rooms
• 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:
• Emotional dysregulation
• Impulsivity (including avoidance)
• Interpersonal challenges
• Teenager and family challenges
• 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

You may not qualify if…

• • 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)

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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