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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Dialectical Behavior Therapy for Adolescents (DBT-A) can assist teens with fetal alcohol spectrum disorders (FASD). It examines the perspectives of teens, caregivers, and therapists on the therapy, as well as its challenges and benefits. Suitable participants have FASD, reside in New York, and experience emotional or behavioral challenges, such as mood swings or relationship difficulties. The trial includes virtual therapy sessions for both teens and their caregivers. As an unphased trial, it provides a unique opportunity for participants to contribute to the understanding and enhancement of therapeutic approaches for FASD.

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 prior data suggests that this therapy is safe for adolescents with FASD?

Research has shown that Dialectical Behavior Therapy for Adolescents (DBT-A) is generally safe and well-received. This therapy has been adapted for various groups with different mental health conditions. No major safety concerns exist for using DBT-A with teens who have Fetal Alcohol Spectrum Disorders (FASD). DBT-A teaches skills like managing emotions and coping, which are non-invasive and don't require medication, resulting in a very low risk of negative effects. Although specific data on using this therapy for FASD is limited, the overall safety record of DBT-A remains reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dialectical Behavior Therapy for Adolescents (DBT-A) is unique because it offers a tailored therapeutic approach specifically designed for teens with Fetal Alcohol Spectrum Disorders (FASD). Unlike standard treatments that often focus on medication or general behavioral strategies, DBT-A incorporates mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness skills, which are crucial for managing the complex emotional and behavioral challenges associated with FASD. Researchers are excited because DBT-A has the potential to directly address the underlying emotional dysregulation and improve overall functioning, offering a more holistic and personalized intervention compared to conventional approaches.

What evidence suggests that dialectical behavior therapy might be an effective treatment for fetal alcohol spectrum disorders?

Research has shown that Dialectical Behavior Therapy for Adolescents (DBT-A) can help young people with Fetal Alcohol Spectrum Disorders (FASD). Studies have found significant improvements in participants' suicidal thoughts, self-harm, emotional control, and depression. In this trial, researchers will administer DBT-A to a single cohort of teens with FASD to test its feasibility. This therapy aims to help teens with FASD manage their emotions better and reduce harmful behaviors. Evidence suggests that DBT-A could be a promising way to improve mental health in teens with FASD. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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 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: Willing and able to attend group sessions virtually

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/dialectical-behavior-therapy-for-fetal-alcohol-spectrum-disorders-36013

Dialectical Behavior Therapy for Fetal Alcohol Spectrum ... Participants demonstrated significant improvements in key areas such as suicidality, self-injurious behavior, emotional dysregulation, and depressive symptoms, ...

2. reporter.nih.gov reporter.nih.gov/search/yHskkMyWNkGlHvVlxYgwUw/project-details/8303309

petrenko, christie lynn mcgee Improving Mental Health Outcomes for Fetal Alcohol Spectrum Disorder: Tailoring Dialectical Behavior Therapy for Adolescents in a Community Mental Health Clinic.

3. psych.rochester.edu psych.rochester.edu/MHFC/research/current-studies/fetal-alcohol-spectrum-disorders-research-studies/

Fetal Alcohol Spectrum Disorders Research Studies Project Summary. This study aims to test the feasibility of dialectical behavior therapy for adolescents (DBT-A) with fetal alcohol spectrum disorders (FASD).

4. app.trialscreen.org app.trialscreen.org/trials/dialectical-behavior-therapy-adolescents-fetal-alcohol-spectrum-disorders-trial-nct06747650

Dialectical Behavior Therapy for Adolescents with FASD The study aims to assess the acceptability of Dialectical Behavior Therapy for Adolescents (DBT-A) from the perspectives of teens with Fetal Alcohol Spectrum ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7839542/

A Systematic Review of Interventions to Improve Mental ... Individuals with fetal alcohol spectrum disorder (FASD) experience remarkably high rates of mental health and substance use challenges, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4569135/

Positive Behavioral Interventions and Family Support for ... Other evidence-based interventions, such as dialectical behavioral therapy (DBT; [72,73]), might work well for people with FASD if appropriately adapted to ...

7. paloaltou.edu paloaltou.edu/resources/translating-research-into-practice-blog/young-offenders-with-fetal-alcohol-spectrum-disorder-demonstrate-more-impairment-on-psycholegal-abilities/

Young Offenders with Fetal Alcohol Spectrum Disorder ... “In total, 76% of young offenders in the FASD group demonstrated impaired performance on the Understanding scale, 24% had impaired scores on the Appreciation ...