The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
Primary Purpose
Substance Use, Psychopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
motivational enhancement therapy
standard care
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use focused on measuring substance use, psychopathy, motivational enhancement, criminal recidivism
Eligibility Criteria
Inclusion Criteria:
- In local pretrial services program; English speaking
Exclusion Criteria:
- Psychosis, inability to provide informed consent
Sites / Locations
- Pretrial Services, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
brief therapy
Standard Care
Arm Description
motivational enhancement therapy for substance use
standard care
Outcomes
Primary Outcome Measures
Percent Days Abstinent Per Month From Drug Use
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)
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
New criminal charge vs. no new criminal charge at follow-up as indicated by county database.
Full Information
NCT ID
NCT01532934
First Posted
January 31, 2012
Last Updated
October 19, 2016
Sponsor
University of Rochester
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01532934
Brief Title
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
Official Title
The Impact of Psychopathic Traits on the Efficacy of a Brief Intervention for Substance Use
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Psychopathy
Keywords
substance use, psychopathy, motivational enhancement, criminal recidivism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brief therapy
Arm Type
Experimental
Arm Description
motivational enhancement therapy for substance use
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
standard care
Intervention Type
Behavioral
Intervention Name(s)
motivational enhancement therapy
Other Intervention Name(s)
SBIRT; brief motivational intervention
Intervention Description
Four 45-minute MET sessions
Intervention Type
Other
Intervention Name(s)
standard care
Primary Outcome Measure Information:
Title
Percent Days Abstinent Per Month From Drug Use
Description
Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.
Time Frame
three to six months post baseline
Secondary Outcome Measure Information:
Title
Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)
Description
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.
Time Frame
six months
Title
New Criminal Charge
Description
New criminal charge vs. no new criminal charge at follow-up as indicated by county database.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In local pretrial services program; English speaking
Exclusion Criteria:
Psychosis, inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc T. Swogger, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pretrial Services, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26727409
Citation
Swogger MT, Conner KR, Caine ED, Trabold N, Parkhurst MN, Prothero LM, Maisto SA. A test of core psychopathic traits as a moderator of the efficacy of a brief motivational intervention for substance-using offenders. J Consult Clin Psychol. 2016 Mar;84(3):248-58. doi: 10.1037/ccp0000065. Epub 2016 Jan 4. Erratum In: J Consult Clin Psychol. 2016 Mar;84(3):210.
Results Reference
result
Links:
URL
https://www.urmc.rochester.edu/people/26773384-marc-t-swogger/researchers
Description
PI web page
Learn more about this trial
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
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