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

NCT ID: NCT00302575

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance-Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Collaborative Behavioral Management

Intervention Type BEHAVIORAL

Integrated parole and outpatient addiction treatment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter D Friedmann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Connecticut Deptartment of Mental Health & Addiction Services

Hartford, Connecticut, United States

Site Status RECRUITING

University of Delaware

Newark, Delaware, United States

Site Status RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status NOT_YET_RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter D Friedmann, MD, MPH

Role: CONTACT

401-444-3347

Kristina Richards, MA

Role: CONTACT

401-444-5838

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

William Burdon, PhD

Role: primary

310-445-0874 ext. 333

Carter Bartee, BA

Role: backup

503-241-7145

Eleni Rodis

Role: primary

860-418-6663

Daniel J O'Connell, PhD

Role: primary

302-831-4649

Conrad J Wong, PhD

Role: primary

859-323-6774

Anne G Rhodes, MA

Role: primary

804-827-1160

Melinda Gales

Role: backup

(804) 628-0646

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 22175445 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1U01DA016191

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methadone Maintenance for Prisoners
NCT00378079 COMPLETED PHASE3
Galantamine and CBT4CBT Pilot to Prevent Relapse.
NCT03547622 COMPLETED EARLY_PHASE1