Clinical trial NCT00302575: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Substance-Related Disorders
Prisoners
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2006-03-14
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Rearrest
Secondary outcomes:
measure: Drug use
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Hartford
country: United States
facility: Connecticut Deptartment of Mental Health & Addiction Services
state: Connecticut
city: Newark
country: United States
facility: University of Delaware
state: Delaware
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Rhode Island Hospital
name: Peter D Friedmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.