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Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees

Primary Purpose

Substance-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Behavioral Management
Integrated parole and outpatient addiction treatment
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Substance-Related Disorders, Prisoners

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: be at least 18 years old and speak English; have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II; be at moderate-to-high-risk of drug relapse and/or recidivism as determined by a Lifestyle Criminality Screening Form (LCSF) score of 7 or greater, or a history of 2 or greater prior treatments for drug-related problems or drug-related convictions; must have substance use treatment as a mandated or recommended condition of parole. Exclusion Criteria: psychotic features; parole or probation conditions that prohibit them from participating in the protocol.

Sites / Locations

  • University of California, Los AngelesRecruiting
  • Connecticut Deptartment of Mental Health & Addiction ServicesRecruiting
  • University of DelawareRecruiting
  • University of Kentucky
  • Virginia Commonwealth University

Outcomes

Primary Outcome Measures

Rearrest

Secondary Outcome Measures

Drug use

Full Information

First Posted
March 13, 2006
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
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1. Study Identification

Unique Protocol Identification Number
NCT00302575
Brief Title
Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
Official Title
Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)

4. Oversight

5. Study Description

Brief Summary
The main purpose of this study is to examine whether improved integration between the community supervision system and outpatient addiction treatment system can improve treatment adherence, drug use and public safety outcomes among drug-involved inmates re-entering the community.
Detailed Description
The target population consists of male and female parolees with a history of substance abuse treatment who are at moderate-to-high-risk of recidivism. They will recruited from in the criminal justice system and/or transitional residential drug treatment within one or two months of release or at the time they first report for parole supervision. Participants from six states (KY, OR, RI, CT, VA, DE) will be randomized into the Step'n Out condition (integration of community supervision and addiction treatment with behavioral management) or a comparison condition including traditional community supervision and addiction treatment. Research interviews at baseline, and 3 and 9 months after release from confinement will assess study participants' outcomes. The Step'n Out intervention will produce significantly better outcomes than the standard referral condition with respect to: recidivism rates (revocation, rearrest on a new charge, reconviction, reincarceration), as assessed 3 and 9 months after the end of the intervention; treatment participation (i.e., proportion of planned sessions attended, proportion of planned days retained in treatment, type of discharge [successful completion, transfer to another program, elopement, administrative discharge, return to custody], as assessed after the end of the intervention; self-reported drug use, criminal activity, and psychosocial functioning, as assessed 3 and 12 months after the end of the intervention; cost-effectiveness; collaboration between the supervision officer and treatment counselor ; and therapeutic alliance with the clients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Substance-Related Disorders, Prisoners

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Collaborative Behavioral Management
Intervention Type
Procedure
Intervention Name(s)
Integrated parole and outpatient addiction treatment
Primary Outcome Measure Information:
Title
Rearrest
Secondary Outcome Measure Information:
Title
Drug use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: be at least 18 years old and speak English; have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II; be at moderate-to-high-risk of drug relapse and/or recidivism as determined by a Lifestyle Criminality Screening Form (LCSF) score of 7 or greater, or a history of 2 or greater prior treatments for drug-related problems or drug-related convictions; must have substance use treatment as a mandated or recommended condition of parole. Exclusion Criteria: psychotic features; parole or probation conditions that prohibit them from participating in the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter D Friedmann, MD, MPH
Phone
401-444-3347
Email
pfriedmann@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Richards, MA
Phone
401-444-5838
Email
krichards@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter D Friedmann, MD, MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Burdon, PhD
Phone
310-445-0874
Ext
333
Email
wburdon@ucla.edu
First Name & Middle Initial & Last Name & Degree
Carter Bartee, BA
Phone
503-241-7145
Email
cbartee@ucla.edu
First Name & Middle Initial & Last Name & Degree
Michael Prendergast, PhD
Facility Name
Connecticut Deptartment of Mental Health & Addiction Services
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Rodis
Phone
860-418-6663
Email
Eleni.Rodis@po.state.ct.us
First Name & Middle Initial & Last Name & Degree
Linda K Frisman, PhD
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel J O'Connell, PhD
Phone
302-831-4649
Email
oconnell@UDel.Edu
First Name & Middle Initial & Last Name & Degree
Steven S. Martin, PhD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conrad J Wong, PhD
Phone
859-323-6774
Email
conrad.wong@uky.edu
First Name & Middle Initial & Last Name & Degree
Carl G Leukefeld, DSW
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne G Rhodes, MA
Phone
804-827-1160
Email
agrhodes@vcu.ed
First Name & Middle Initial & Last Name & Degree
Melinda Gales
Phone
(804) 628-0646
Email
mgales@mail1.vcu.edu
First Name & Middle Initial & Last Name & Degree
Faye S Taxman, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22175445
Citation
Friedmann PD, Green TC, Taxman FS, Harrington M, Rhodes AG, Katz E, O'Connell D, Martin SS, Frisman LK, Litt M, Burdon W, Clarke JG, Fletcher BW; Step'n Out Research Group of CJ-DATS. Collaborative behavioral management among parolees: drug use, crime and re-arrest in the Step'n Out randomized trial. Addiction. 2012 Jun;107(6):1099-108. doi: 10.1111/j.1360-0443.2011.03769.x. Epub 2012 Feb 28.
Results Reference
derived

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Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees

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