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

February 3, 2026 updated by: Christie Petrenko, University of Rochester
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active DBT-A Intervention Arm
A single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difficulties in emotion regulation scale caregiver and self-report
Time Frame: Baseline and Week 35
The Difficulties in Emotion Regulation Scale (DERS) is a validated self-report measure designed to assess challenges in regulating emotions. It evaluates six dimensions of emotion regulation difficulties: non-acceptance of emotional responses, difficulties engaging in goal-directed behavior when distressed, impulse control challenges during emotional distress, lack of emotional awareness, limited access to effective emotion regulation strategies, and lack of clarity about emotional experiences. This study will utilize the brief form consisting of 18 items rated on a Likert scale, with higher scores indicating greater difficulties in emotion regulation. Each scale has a score range of 3 to 15.
Baseline and Week 35
Child behavior checklist caregiver and youth report
Time Frame: Baseline and week 35
The Child Behavior Checklist (CBCL) is a standardized, parent-reported questionnaire designed to assess a wide range of emotional and behavioral problems in children and adolescents. It is part of the Achenbach System of Empirically Based Assessment (ASEBA) and evaluates competencies and problems in various domains. The CBCL yields scores across internalizing behaviors (e.g., anxiety, depression), externalizing behaviors (e.g., aggression, rule-breaking), and total problems. It also provides syndrome scales (e.g., anxious/depressed, somatic complaints, social problems) and DSM-oriented scales aligned with diagnostic criteria. The scales are reported as t-scores with a mean of 50 and a standard deviation of 10. The higher the t-score, the more significant the behavioral issues.
Baseline and week 35
The theoretical framework of acceptability questionnaire
Time Frame: Week 35
The Theoretical Framework of Acceptability (TFA) defines acceptability as a multi-dimensional construct. The TFA identifies several dimensions that shape individuals' experiences with an intervention, including their affective attitude toward the intervention, the perceived burden or effort required to engage with it, the alignment of the intervention with their personal values and beliefs, and the extent to which they understand its purpose and mechanisms. It also considers the perceived opportunity costs of participation, participants' beliefs about the intervention's effectiveness, and their confidence in their ability to successfully engage with it. Each question is a 5-point Likert scale, with higher scores indicating highter acceptability of treatment.
Week 35

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9-item
Time Frame: Base line to 9 months
The Patient Health Questionnaire-9 (PHQ-9) is a widely used self-report tool designed to screen for, diagnose, and monitor the severity of depressive symptoms. It is based on the diagnostic criteria for major depressive disorder outlined in the DSM, making it a clinically relevant and psychometrically robust measure. The PHQ-9 consists of nine items that assess the frequency of core depressive symptoms, such as low mood, loss of interest or pleasure in activities, fatigue, changes in sleep or appetite, feelings of worthlessness, difficulty concentrating, and thoughts of self-harm or death. Respondents rate the severity of these symptoms over the past two weeks on a four-point scale, ranging from "not at all" to "nearly every day," yielding a total score that indicates depression severity. Higher scores suggest more severe depressive symptoms.
Base line to 9 months
General Anxiety Disorder 7-item
Time Frame: Base line to 9 months
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a brief, self-report measure designed to screen for, assess, and monitor the severity of generalized anxiety symptoms. It evaluates core symptoms of anxiety based on criteria outlined in the DSM, including excessive worry, restlessness, difficulty concentrating, irritability, muscle tension, and sleep disturbance. Respondents rate the frequency of these symptoms over the past two weeks on a four-point Likert scale, ranging from "not at all" to "nearly every day." The total score provides an indication of anxiety severity, with higher scores reflecting greater symptom burden.
Base line to 9 months
Clinician therapeutic note documentation
Time Frame: Base line to 9 months
Clinician documentation of client participation, homework completion, attention during session, camera use during virtual sessions, and therapy-interfering behaviors.
Base line to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00009819
  • 1F31AA031596-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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