NCT04773340

Brief 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. District Court of the Southern District of New York (the RISE Court program).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

February 23, 2021

Last Update Submit

February 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Completion of the treatment program

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

    4 months after initiation of treatment

Secondary Outcomes (5)

  • Impulsivitity,

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

  • Distress tolerance

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

  • Emotion regulation

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

  • Mindfulness

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

  • Renewed criminal charges following completion of treatment

    1 year

Study Arms (1)

DBT intervention

Adaptation of Dialectical Behavior Therapy designed for repeat criminal offenders at high risk of reoffense.

Behavioral: Dialectical Behavior Therapy

Interventions

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

DBT intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fordham University Community Mental Health Clinic

The Bronx, New York, 104580000, United States

Location

MeSH Terms

Conditions

Antisocial Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Barry Rosenfeld, PhD

    Fordham University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barry Rosenfeld, PhD

CONTACT

Michele Galietta, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/Principle Investigator

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

October 1, 2021

Primary Completion

May 31, 2023

Study Completion

September 30, 2023

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations