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

NCT06747650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Rochester

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2025-10-29
Completion
2025-10-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06747650 on ClinicalTrials.gov