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The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532934
First Posted: February 15, 2012
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
MarcSwogger, University of Rochester
  Purpose
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.

Condition Intervention Phase
Substance Use Psychopathy Behavioral: motivational enhancement therapy Other: standard care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Psychopathic Traits on the Efficacy of a Brief Intervention for Substance Use

Further study details as provided by MarcSwogger, University of Rochester:

Primary Outcome Measures:
  • Percent Days Abstinent Per Month From Drug Use [ Time Frame: three to six months post baseline ]
    Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.


Secondary Outcome Measures:
  • Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD) [ Time Frame: six months ]
    A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.

  • New Criminal Charge [ Time Frame: one year ]
    New criminal charge vs. no new criminal charge at follow-up as indicated by county database.


Enrollment: 105
Study Start Date: August 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: brief therapy
motivational enhancement therapy for substance use
Behavioral: motivational enhancement therapy
Four 45-minute MET sessions
Other Name: SBIRT; brief motivational intervention
Placebo Comparator: Standard Care
standard care
Other: standard care

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In local pretrial services program; English speaking

Exclusion Criteria:

  • Psychosis, inability to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532934


Locations
United States, New York
Pretrial Services, Inc.
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Marc T. Swogger, Ph.D. University of Rochester
  More Information

Additional Information:
Publications:
Responsible Party: MarcSwogger, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01532934     History of Changes
Other Study ID Numbers: 28780
K23DA027720 ( U.S. NIH Grant/Contract )
First Submitted: January 31, 2012
First Posted: February 15, 2012
Results First Submitted: October 6, 2015
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MarcSwogger, University of Rochester:
substance use
psychopathy
motivational enhancement
criminal recidivism

Additional relevant MeSH terms:
Antisocial Personality Disorder
Personality Disorders
Mental Disorders