NCT01532934

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 12, 2016

Completed
Last Updated

December 12, 2016

Status Verified

October 1, 2016

Enrollment Period

4.9 years

First QC Date

January 31, 2012

Results QC Date

October 6, 2015

Last Update Submit

October 19, 2016

Conditions

Keywords

substance usepsychopathymotivational enhancementcriminal recidivism

Outcome Measures

Primary Outcomes (1)

  • 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.

    three to six months post baseline

Secondary Outcomes (2)

  • Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)

    six months

  • New Criminal Charge

    one year

Study Arms (2)

brief therapy

EXPERIMENTAL

motivational enhancement therapy for substance use

Behavioral: motivational enhancement therapy

Standard Care

PLACEBO COMPARATOR

standard care

Other: standard care

Interventions

Four 45-minute MET sessions

Also known as: SBIRT; brief motivational intervention
brief therapy
Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In local pretrial services program; English speaking

You may not qualify if:

  • Psychosis, inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pretrial Services, Inc.

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Substance-Related DisordersAntisocial Personality DisorderRecidivism

Interventions

Motivational InterviewingStandard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonality DisordersCriminal BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Marc T. Swogger, Ph.D.
Organization
University of Rochester

Study Officials

  • Marc T. Swogger, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 15, 2012

Study Start

August 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 12, 2016

Results First Posted

December 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations