- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773340
Adapting Dialectical Behavior Therapy for the Treatment of Criminal Offenders With Antisocial Personality Disorder (DBT-ASPD)
February 24, 2021 updated by: Barry Rosenfeld, Fordham University
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BARRY ROSENFELD, PhD
- Phone Number: 718-817-3794
- Email: ROSENFELD@FORDHAM.EDU
Study Contact Backup
- Name: Michele Galietta, PhD
- Email: mgalietta@gmail.com
Study Locations
-
-
New York
-
Bronx, New York, United States, 104580000
- Fordham University Community Mental Health Clinic
-
Contact:
- BARRY ROSENFELD, PhD
- Phone Number: 718-817-3794
- Email: ROSENFELD@FORDHAM.EDU
-
Contact:
- Christopher Conway, PhD
- Phone Number: 718-817-0106
- Email: cconway26@fordham.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Criminal offenders on probation in the Southern District of New York's intensive supervision program.
Description
Inclusion Criteria:
- Over 18, English speaking, Participating in RISE Court program
Exclusion Criteria:
- Evidence of psychotic symptoms that would preclude meaningful participation in treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DBT intervention
Adaptation of Dialectical Behavior Therapy designed for repeat criminal offenders at high risk of reoffense.
|
Behaviorally-focused intervention for individuals with personality disorder and a history of significant behavioral problems.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of the treatment program
Time Frame: 4 months after initiation of treatment
|
Individuals will be classified as "completers" if they have finished the entire 16 week treatment program
|
4 months after initiation of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impulsivitity,
Time Frame: Post-treatment (approximately 4 months after initiation of treatment)
|
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
|
Post-treatment (approximately 4 months after initiation of treatment)
|
Distress tolerance
Time Frame: Post-treatment (approximately 4 months after initiation of treatment)
|
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
|
Post-treatment (approximately 4 months after initiation of treatment)
|
Emotion regulation
Time Frame: Post-treatment (approximately 4 months after initiation of treatment)
|
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
|
Post-treatment (approximately 4 months after initiation of treatment)
|
Mindfulness
Time Frame: Post-treatment (approximately 4 months after initiation of treatment)
|
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
|
Post-treatment (approximately 4 months after initiation of treatment)
|
Renewed criminal charges following completion of treatment
Time Frame: 1 year
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barry Rosenfeld, PhD, Fordham University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2021
Primary Completion (Anticipated)
May 31, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
February 23, 2021
First Submitted That Met QC Criteria
February 24, 2021
First Posted (Actual)
February 26, 2021
Study Record Updates
Last Update Posted (Actual)
February 26, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 957186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Because this is a pilot study it is unclear whether data will be made available to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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