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

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Prendergast, PhD
    • Connecticut
      • Hartford, Connecticut, United States, 06134
        • Recruiting
        • Connecticut Deptartment of Mental Health & Addiction Services
        • Contact:
        • Principal Investigator:
          • Linda K Frisman, PhD
    • Delaware
      • Newark, Delaware, United States, 19716
        • Recruiting
        • University of Delaware
        • Contact:
        • Principal Investigator:
          • Steven S. Martin, PhD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Not yet recruiting
        • University Of Kentucky
        • Contact:
        • Principal Investigator:
          • Carl G Leukefeld, DSW
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Not yet recruiting
        • Virginia Commonwealth University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faye S Taxman, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rearrest

Secondary Outcome Measures

Outcome Measure
Drug use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Substance Abuse and Mental Health Services Administration (SAMHSA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Anticipated)

August 1, 2007

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 14, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01DA016191 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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