Clinical trial NCT06747650: Dialectical Behavior Therapy for Adolescents with Fetal Alcohol Spectrum Disorders Feasibility Trial
Official title: Dialectical Behavior Therapy for Adolescents with Fetal Alcohol Spectrum Disorders Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorder
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-12-24
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing.
Primary purpose: TREATMENT

Brief summary: 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.


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)

Primary outcomes:
measure: Difficulties in emotion regulation scale caregiver and self-report
timeFrame: Baseline and Week 35
measure: Child behavior checklist caregiver and youth report
timeFrame: Baseline and week 35
measure: The theoretical framework of acceptability questionnaire
timeFrame: Week 35
Secondary outcomes:
measure: Patient Health Questionnaire 9-item
timeFrame: Base line to 9 months
measure: General Anxiety Disorder 7-item
timeFrame: Base line to 9 months
measure: Clinician therapeutic note documentation
timeFrame: Base line to 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: