Dialectical Behavior Therapy for Fetal Alcohol Spectrum Disorders

Overseen By Maddy Rockhold, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Primary psychotic disorder, substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 35 weeks

10 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Dialectical Behavior Therapy for Adolescents for Fetal Alcohol Spectrum Disorders?

Dialectical Behavior Therapy for Adolescents (DBT-A) has shown promise in treating emotional and behavioral issues in adolescents, such as reducing aggressive behavior and improving emotion regulation. While specific data for Fetal Alcohol Spectrum Disorders is not available, the therapy's success in similar conditions suggests it may be beneficial. ^{1 2 3 4 5}

Is Dialectical Behavior Therapy safe for adolescents and young adults?

Dialectical Behavior Therapy (DBT) has been used safely with adolescents and young adults for various conditions, including emotional and behavioral issues, bipolar disorder, and self-harming behavior. Studies show that DBT is generally well-tolerated and can lead to improvements in emotional regulation and behavior. ^{2 5 6 7 8}

How is Dialectical Behavior Therapy for Adolescents different from other treatments for Fetal Alcohol Spectrum Disorders?

Dialectical Behavior Therapy for Adolescents (DBT-A) is unique because it focuses on improving emotion regulation and reducing aggressive behaviors, which can be beneficial for individuals with Fetal Alcohol Spectrum Disorders who often struggle with emotional and behavioral challenges. Unlike standard treatments, DBT-A incorporates skills training to help manage emotions and behaviors effectively. ^{2 3 5 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adolescents with Fetal Alcohol Spectrum Disorders (FASD) and their caregivers. Participants will join an adapted Dialectical Behavior Therapy program designed for neurodivergent teens. The study aims to include two groups of five adolescents each.

Inclusion Criteria

For caregivers: Willing and able to attend group sessions virtually

For adolescents: Have functional deficits in three of five problem areas: Emotional dysregulation, Impulsivity (including avoidance), Interpersonal challenges, Teenager and family challenges, Reduced awareness and focus

For caregivers: Access to the internet and device with Zoom capabilities

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dialectical behavior therapy for adolescents (DBT-A) adapted for neurodivergent teens, including individual therapy, group skills training, and 24/7 phone coaching

35 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dialectical Behavior Therapy for Adolescents

Trial Overview The trial is testing the feasibility of a comprehensive Dialectical Behavior Therapy program for adolescents with FASD, which includes individual therapy, group skills training, and round-the-clock phone coaching.

Participant Groups

Group I: Active DBT-A Intervention Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Dialectical behavior therapy for adolescents (DBT-A) is effective in reducing suicidal behaviors and can also be adapted for young adults aged 18-26, although the observed effect size in this study was smaller than in previous efficacy trials.

Young adults in the study had different service utilization patterns compared to adolescents, participating in fewer family sessions and graduating from the program more quickly, indicating potential differences in treatment needs and outcomes between these age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the family-based model of dialectical behavior therapy for both suicidal adolescents and young adults in an academic medical center. Darrow, SM., Maliken, AC., Piatigorsky, A., et al.[2022]

Dialectical Behavior Therapy for adolescents (DBT-A) has shown promising improvements in treating borderline personality disorder, but there is a need for more research to establish its effectiveness, especially regarding family involvement in treatment.

Innovative approaches, such as integrating smartphone-based assessments and interventions into DBT-A, could enhance therapy by providing timely skills and improving therapist-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting report of the 2nd German dialectical behavior therapy for adolescents network meeting. Hammerle, F., Bürger, A., Kaess, M., et al.[2020]

Dialectical behaviour therapy for adolescents (DBT-A) was effectively implemented in publicly funded mental health services in Ireland, involving 54 clinicians and 84 adolescents over a 16-week program.

Participants in the DBT-A program showed significant reductions in self-harm, suicidal thoughts, and depression, along with decreased hospital admissions and emergency visits, indicating its efficacy in treating emotional and behavioral dysregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Dialectical behaviour therapy for adolescents: multisite implementation and evaluation of a 16-week programme in a public community mental health setting. Flynn, D., Kells, M., Joyce, M., et al.[2020]

In a pilot study involving 20 adolescents with bipolar disorder, those receiving dialectical behavior therapy (DBT) showed significantly less severe depressive symptoms and were nearly three times more likely to improve in suicidal ideation compared to those receiving standard psychosocial treatment.

DBT participants attended more therapy sessions, indicating higher engagement, and demonstrated improvements in manic symptoms and emotional dysregulation from pre- to post-treatment, suggesting that DBT may be a beneficial adjunct to medication for managing early-onset bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. Goldstein, TR., Fersch-Podrat, RK., Rivera, M., et al.[2022]

An adapted version of dialectical behavior therapy (DBT) for adolescents with bipolar disorder showed high feasibility and acceptability, with 90% of scheduled sessions attended and 9 out of 10 patients completing the treatment over one year.

Participants demonstrated significant improvements in key areas such as suicidality, self-injurious behavior, emotional dysregulation, and depressive symptoms, suggesting that DBT could be an effective psychosocial treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. Goldstein, TR., Axelson, DA., Birmaher, B., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of dialectical behavior therapy for suicidal adolescent inpatients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the family-based model of dialectical behavior therapy for both suicidal adolescents and young adults in an academic medical center. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Dialectical Behavioral Therapy for Male Adolescents with Borderline Symptomatology]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Meeting report of the 2nd German dialectical behavior therapy for adolescents network meeting. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Dialectical behaviour therapy for adolescents: multisite implementation and evaluation of a 16-week programme in a public community mental health setting. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Dialectical-behavioral outpatient therapy for adolescents with impulsive and self-harming behavior]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Transdiagnostic Applications of DBT for Adolescents and Adults. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy skills training for the treatment of addictive behaviours among individuals with alcohol use disorder: the effect of emotion regulation and experiential avoidance. [2021]