- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532934
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
October 19, 2016 updated by: MarcSwogger, University of Rochester
The Impact of Psychopathic Traits on the Efficacy of a Brief Intervention for Substance Use
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- Pretrial Services, Inc.
-
-
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
Description
Inclusion Criteria:
- In local pretrial services program; English speaking
Exclusion Criteria:
- Psychosis, inability to provide informed consent
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Standard Care
standard care
|
|
|
Experimental: brief therapy
motivational enhancement therapy for substance use
|
Four 45-minute MET sessions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
three to six months post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
six months
|
|
New Criminal Charge
Time Frame: one year
|
New criminal charge vs. no new criminal charge at follow-up as indicated by county database.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc T. Swogger, Ph.D., University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
August 1, 2009
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
January 31, 2012
First Submitted That Met QC Criteria
February 10, 2012
First Posted (Estimate)
February 15, 2012
Study Record Updates
Last Update Posted (Estimate)
December 12, 2016
Last Update Submitted That Met QC Criteria
October 19, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28780
- K23DA027720 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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