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Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), August 2006
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00302575
  Purpose

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.


Condition Intervention
Substance-Related Disorders
Behavioral: Collaborative Behavioral Management
Procedure: Integrated parole and outpatient addiction treatment

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Rearrest

Secondary Outcome Measures:
  • Drug use

Estimated Enrollment: 420
Study Start Date: February 2005
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. be at least 18 years old and speak English;
  2. have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II;
  3. 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;
  4. must have substance use treatment as a mandated or recommended condition of parole.

Exclusion Criteria:

  1. psychotic features;
  2. parole or probation conditions that prohibit them from participating in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302575

Contacts
Contact: Peter D Friedmann, MD, MPH 401-444-3347 pfriedmann@lifespan.org
Contact: Kristina Richards, MA 401-444-5838 krichards@lifespan.org

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: William Burdon, PhD     310-445-0874 ext 333     wburdon@ucla.edu    
Contact: Carter Bartee, BA     503-241-7145     cbartee@ucla.edu    
Principal Investigator: Michael Prendergast, PhD            
United States, Connecticut
Connecticut Deptartment of Mental Health & Addiction Services Recruiting
Hartford, Connecticut, United States, 06134
Contact: Eleni Rodis     860-418-6663     Eleni.Rodis@po.state.ct.us    
Principal Investigator: Linda K Frisman, PhD            
United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Contact: Daniel J O'Connell, PhD     302-831-4649     oconnell@UDel.Edu    
Principal Investigator: Steven S. Martin, PhD            
United States, Kentucky
University of Kentucky Not yet recruiting
Lexington, Kentucky, United States, 40536
Contact: Conrad J Wong, PhD     859-323-6774     conrad.wong@uky.edu    
Principal Investigator: Carl G Leukefeld, DSW            
United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23284
Contact: Anne G Rhodes, MA     804-827-1160     agrhodes@vcu.ed    
Contact: Melinda Gales     (804) 628-0646     mgales@mail1.vcu.edu    
Principal Investigator: Faye S Taxman, PhD            
Sponsors and Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
Principal Investigator: Peter D Friedmann, MD, MPH Rhode Island Hospital
  More Information

The National Institute on Drug Abuse (NIDA) established CJ-DATS as a cooperative research program to explore the issues related to the complex system of offender treatment services.  This link exits the ClinicalTrials.gov site

Study ID Numbers: 1U01DA016191
Study First Received: March 13, 2006
Last Updated: August 21, 2006
ClinicalTrials.gov Identifier: NCT00302575  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Substance-Related Disorders
Prisoners

Study placed in the following topic categories:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009