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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302575
Recruitment Status : Unknown
Verified August 2006 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Recruiting
First Posted : March 14, 2006
Last Update Posted : January 11, 2017
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Collaborative Behavioral Management Procedure: Integrated parole and outpatient addiction treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
Study Start Date : February 2005
Estimated Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Rearrest

Secondary Outcome Measures :
  1. Drug use

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302575

Contact: Peter D Friedmann, MD, MPH 401-444-3347
Contact: Kristina Richards, MA 401-444-5838

United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: William Burdon, PhD    310-445-0874 ext 333   
Contact: Carter Bartee, BA    503-241-7145   
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   
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   
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   
Principal Investigator: Faye S Taxman, PhD         
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Principal Investigator: Peter D Friedmann, MD, MPH Rhode Island Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00302575     History of Changes
Other Study ID Numbers: 1U01DA016191 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: August 2006

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders