Fetal Alcohol Spectrum DisorderNCT06747650
Dialectical Behavior Therapy for Adolescents With Fetal Alcohol Spectrum Disorders Feasibility Trial
A study testing Dialectical Behavior Therapy for Adolescents in people with Fetal Alcohol Spectrum Disorder, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorder
- What is being tested?
- Dialectical Behavior Therapy for Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2024to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 24Show fewer
- A diagnosis of disruptive mood dysregulation disorder, borderline personality disorder, or multiple other serious mental health diagnoses
- A history of multiple psychiatric hospitalizations and/or recurring presentation at psychiatric emergency rooms
- 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:
- Emotional dysregulation
- Impulsivity (including avoidance)
- Interpersonal challenges
- Teenager and family challenges
- 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
Who cannot join
- • 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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
- Being tested
- Dialectical Behavior Therapy for Adolescents
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy for AdolescentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active DBT-A Intervention Arm | Experimental | A single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing. Receives: Behavioral: Dialectical Behavior Therapy for Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 35
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Base line to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start24 Dec 2024
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christie Petrenko, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747650
- Sponsor's protocol ID
- STUDY00009819
- Other IDs
- 1F31AA031596-01
- Status last verified
- Feb 2026
- First submitted
- 18 Dec 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Adolescents With Fetal Alcohol Spectrum Disorders Feasibility Trial
- ClinicalTrials.gov ID
- NCT06747650
- Acronym / sponsor ID
- STUDY00009819
- Conditions
- Fetal Alcohol Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing.
| Arm | Type | Receives |
|---|---|---|
| Active DBT-A Intervention Arm | Experimental | Behavioral: Dialectical Behavior Therapy for AdolescentsA single cohort of teens with FASD will be administered DBT-A for the purpose of feasibility testing. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- 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:
Key exclusion criteria (4 listed)
- • Adolescent, caregiver, or clinician has insufficient proficiency in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior Therapy for AdolescentsStandard 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. | Behavioural | Active DBT-A Intervention Arm |
Primary outcome
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.
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.
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.
3 secondary outcomes
Patient Health Questionnaire 9-item
Time frame: Base line to 9 months
General Anxiety Disorder 7-item
Time frame: Base line to 9 months
Clinician therapeutic note documentation
Time frame: Base line to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy for Adolescents in people with Fetal Alcohol Spectrum Disorder, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in emotion regulation scale caregiver and self-report (time frame: Baseline and Week 35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.