An interventional study of Dialectical Behavior Therapy for Adolescents in Fetal Alcohol Spectrum Disorder, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 14 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's enrollment of 9 is below the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Inclusion Criteria:
For adolescents:
Have one of the following:
Have functional deficits in three of five problem areas:
For caregivers:
For clinicians:
Exclusion Criteria:
Adolescent, caregiver, or clinician has insufficient proficiency in English
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.
Difficulties in emotion regulation scale caregiver and self-report
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.
Time frame: Baseline and Week 35
Child behavior checklist caregiver and youth report
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.
Time frame: Baseline and week 35
The theoretical framework of acceptability questionnaire
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.
Time frame: Week 35
Patient Health Questionnaire 9-item
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.
Time frame: Base line to 9 months
General Anxiety Disorder 7-item
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.
Time frame: Base line to 9 months
Clinician therapeutic note documentation
Clinician documentation of client participation, homework completion, attention during session, camera use during virtual sessions, and therapy-interfering behaviors.
Time frame: Base line to 9 months
Plan to share: No
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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