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

NCT ID: NCT06747650

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-24
• Study Completion Date: 2025-10-29

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.

Conditions

Fetal Alcohol Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active DBT-A Intervention Arm

A single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing.

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy for Adolescents

Intervention Type: BEHAVIORAL

Standard of care (SOC) DBT-A includes approximately six weeks of pretreatment, and approximately six months of DBT-A skills group, individual therapy, and 24/7 phone coaching. During pre-treatment, clients are oriented to the DBT-A model and client commitment to treatment is established. After approximately six weeks, the client enters DBT-A skills group along with their caregiver. This skills group meets weekly for 1.5 hours and clinicians explain the five main DBT-A skills (mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness, and walking the middle path) via PowerPoints and discussion. Clients and their caregivers are assigned weekly homework. At the same time, teens are completing weekly 1-hour individual therapy sessions where they are utilizing the skills learned in group. Both teens and caregivers have access to what DBT-A calls 24/7 phone coaching. This phone coaching is 24/7 access to a therapist when a crisis is arising.

Interventions

Dialectical Behavior Therapy for Adolescents

Standard of care (SOC) DBT-A includes approximately six weeks of pretreatment, and approximately six months of DBT-A skills group, individual therapy, and 24/7 phone coaching. During pre-treatment, clients are oriented to the DBT-A model and client commitment to treatment is established. After approximately six weeks, the client enters DBT-A skills group along with their caregiver. This skills group meets weekly for 1.5 hours and clinicians explain the five main DBT-A skills (mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness, and walking the middle path) via PowerPoints and discussion. Clients and their caregivers are assigned weekly homework. At the same time, teens are completing weekly 1-hour individual therapy sessions where they are utilizing the skills learned in group. Both teens and caregivers have access to what DBT-A calls 24/7 phone coaching. This phone coaching is 24/7 access to a therapist when a crisis is arising.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Christie Petrenko

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

1F31AA031596-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009819

Identifier Type: -

Identifier Source: org_study_id