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Antisocial Personality DisorderDBT-ASPDNCT04773340

Adapting Dialectical Behavior Therapy for the Treatment of Criminal Offenders With Antisocial Personality Disorder

An observational study of Antisocial Personality Disorder, run by Fordham University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This pilot study is intended to adapt and refine an intervention grounded in the principles of Dialectical Behavior Therapy, for the treatment of repeat criminal offenders with antisocial personality disorder. This study will be open to individuals participating in an intensive supervision program operated by the U.S. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Antisocial Personality Disorder
What is being tested?
Dialectical Behavior Therapy
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 30 Sep 2023
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Criminal offenders on probation in the Southern District of New York's intensive supervision program.

Who may be able to join

  • Over 18, English speaking, Participating in RISE Court program

Who cannot join

  • Evidence of psychotic symptoms that would preclude meaningful participation in treatment.

Trial locations and contacts

1 site in 1 country.

Barry Rosenfeld, PhD contact

718-817-3794

rosenfeld@fordham.edu

Michele Galietta, PhD contact

mgalietta@gmail.com

United States1 site
  • Fordham University Community Mental Health Clinic

    The Bronx, New York, 104580000

    BARRY ROSENFELD, PhD, 718-817-3794, ROSENFELD@FORDHAM.EDU

    Christopher Conway, PhD, 718-817-0106, cconway26@fordham.edu

Other trials in United States

About this study

This pilot study is intended to adapt and refine an intervention grounded in the principles of Dialectical Behavior Therapy, for the treatment of repeat criminal offenders with antisocial personality disorder. This study will be open to individuals participating in an intensive supervision program operated by the U.S. District Court of the Southern District of New York (the RISE Court program).

Read the detailed description

Antisocial personality disorder (ASPD) is among the most damaging and costly mental disorders, yet little research has sought to address the root causes of this disorder. Indeed, many clinicians consider ASPD to be "untreatable", and have largely relegated the management of this challenging disorder to the criminal justice system, effectively relinquishing responsibility for understanding and treating ASPD. Although a number of interventions are utilized by the criminal justice system, these interventions have typically focused on specific problem behaviors, such as anger management and substance abuse. These interventions, along with the more broad-based approaches occasionally studied (e.g., criminal cognitions) focus primarily on cognitive processing, effectively ignoring core elements of ASPD such as impulsivity and emotion dysregulation. Recently, however, growing interest has centered on Dialectical Behavior Therapy as a potential intervention approach, particularly given the emphasis on tangible behaviors and the acquisition of skills to address the core elements of APSD. The proposed study builds upon an innovative rehabilitative program developed by the U.S. District Court in New York. Beginning in 2020, the Fordham Community Mental Health Clinic has provided a DBT-based intervention to participants in this rehabilitation program. This population is comprised of repeat criminal offenders who are deemed at high risk for reoffending by the Probation Department, the vast majority of whom meet diagnostic criteria for ASPD. This intervention, which builds on the researcher team's past work treating offenders with a history of stalking and intimate partner violence, has the potential to advance the utility of DBT for treatment of this challenging population. The present application proposes to advance this goal, by adapting DBT to target core symptoms of ASPD, including impulsivity, difficulties in emotional processing, and problem solving deficits. By adapting traditional DBT, this intervention hopes to demonstrate increased success in retaining and engaging this challenging population in treatment, decreasing the extent of problematic behaviors, and reducing the rates of violent and criminal reoffense. Most importantly, this application takes an experimental therapeutics approach, by identifying potential mediators of successful change in ASPD and quantifying the extent to which DBT impacts these traits and behaviors. Although DBT is not expected to "cure" ASPD, even modest improvements in the treatability of this challenging population would translate into substantial benefits given the high social, economic and health care costs associated with this disorder. Given these goals, the present application seeks to a) demonstrating the feasibility and acceptability of this intervention, b) reduce problematic character traits and behaviors (e.g., decreased impulsivity, increased emotion recognition), and c) reduce the rates of re-offending.

Being tested
Dialectical Behavior Therapy
Medical subject headings
Antisocial Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior TherapyBehavioural

    Behaviorally-focused intervention for individuals with personality disorder and a history of significant behavioral problems.

Study groups in NCT04773340
Study groupRoleWhat they receive
DBT interventionAdaptation of Dialectical Behavior Therapy designed for repeat criminal offenders at high risk of reoffense.
Receives: Behavioral: Dialectical Behavior Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion of the treatment program

    Individuals will be classified as "completers" if they have finished the entire 16 week treatment program

    Measured: 4 months after initiation of treatment

Secondary outcomes (5)
  1. Impulsivitity,

    Impulsivity will be measured with a self-report measure, the UPPS-P Impulsivity Scale, which will be administered prior to, and following completion of treatment

    Measured: Post-treatment (approximately 4 months after initiation of treatment)

  2. Distress tolerance

    Distress tolerance will be measured with a self-report measure, the Distress Tolerance Scale, which will be administered prior to, and following completion of treatment

    Measured: Post-treatment (approximately 4 months after initiation of treatment)

  3. Emotion regulation

    Distress tolerance will be measured with a self-report measure, the Difficulties in Emotion Regulation Scale, which will be administered prior to, and following completion of treatment

    Measured: Post-treatment (approximately 4 months after initiation of treatment)

  4. Mindfulness

    Mindfulness will be measured with a self-report measure, the Mindful Attention Awareness Scale, which will be administered prior to, and following completion of treatment

    Measured: Post-treatment (approximately 4 months after initiation of treatment)

  5. Renewed criminal charges following completion of treatment

    Participants will be monitored for at least one year following treatment in order to determine whether they have been charged with any additional criminal offenses

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion31 May 2023 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773340
Sponsor's protocol ID
957186
Acronym
DBT-ASPD
Status last verified
Feb 2021
First submitted
23 Feb 2021
Last updated
26 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Because this is a pilot study it is unclear whether data will be made available to other researchers

Questions about this trial

What is this clinical trial studying?

An observational study of Antisocial Personality Disorder, run by Fordham University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barry Rosenfeld, PhD (718-817-3794, rosenfeld@fordham.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of the treatment program (time frame: 4 months after initiation of treatment). 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 26 Feb 2021.

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