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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01532934
Other study ID # 28780
Secondary ID
Status Recruiting
Phase Phase 2
First received January 31, 2012
Last updated February 10, 2012
Start date August 2009
Est. completion date July 2014

Study information

Verified date February 2012
Source University of Rochester
Contact Marc T. Swogger, Ph.D.
Phone 585-275-7418
Email marc_swogger@urmc.rochester.edu
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

Substance use among criminal offenders constitutes a major public health problem and is tied to negative consequences for offenders, their families, and their communities. One of the direst of these consequences is repeated incarceration; thus, interventions that reduce criminal recidivism are needed. Forensic populations are often viewed with considerable therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and the assessment of individual differences among offenders may provide valuable information that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has emerged as an important personality construct for the understanding of violence and criminal recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and lack of remorse may have negative implications for the efficacy of psychosocial interventions. A foundational premise of the present work is that understanding the moderating role of psychopathic traits on substance use treatment outcomes among offenders is essential to determining what works, and for whom. The current proposal is a Phase II randomized clinical trial that aims to examine the impact of psychopathic traits on the efficacy of a brief substance use intervention for offenders in a jail diversion program. Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based treatment will reduce substance use and related consequences relative to a Standard Care only condition, 2) that the reduction in substance use in the intervention group will mediate a reduction in later criminal recidivism relative to the Standard Care condition, and 3) that core psychopathic traits will moderate the efficacy of the intervention such that individuals with lower levels of these traits will derive greater benefits with regard to decreased substance use, decreased drug use consequences, and decreased criminal recidivism at a one-year follow-up.


Description:

Substance use among criminal offenders constitutes a major public health problem and is tied to negative consequences for offenders, their families, and their communities. One of the direst of these consequences is repeated incarceration; thus, interventions that reduce criminal recidivism are needed. Forensic populations are often viewed with considerable therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and the assessment of individual differences among offenders may provide valuable information that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has emerged as an important personality construct for the understanding of violence and criminal recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and lack of remorse may have negative implications for the efficacy of psychosocial interventions. A foundational premise of the present work is that understanding the moderating role of psychopathic traits on substance use treatment outcomes among offenders is essential to determining what works, and for whom. The current proposal is a Phase II randomized clinical trial that aims to examine the impact of psychopathic traits on the efficacy of a brief substance use intervention for offenders in a jail diversion program. Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based treatment will reduce substance use and related consequences relative to a Standard Care only condition, 2) that the reduction in substance use in the intervention group will mediate a reduction in later criminal recidivism relative to the Standard Care condition, and 3) that core psychopathic traits will moderate the efficacy of the intervention such that individuals with lower levels of these traits will derive greater benefits with regard to decreased substance use, decreased drug use consequences, and decreased criminal recidivism at a one-year follow-up. This work has the potential to provide important data regarding which individuals can benefit from a brief intervention for substance use. Such data will inform the effective and efficient allocation of treatment resources for substance using offenders.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- In local pretrial services program; English speaking

Exclusion Criteria:

- Psychosis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Behavioral:
motivational enhancement therapy
Four 45-minute MET sessions
Other:
standard care
standard care

Locations

Country Name City State
United States Pretrial Services, Inc. Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary criminal recidivism criminal charges within one year one year No
Secondary substance use using timeline followback data, use of substances will be assessed six months No
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