Substance-Related DisordersNCT00302575
Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
A study testing Collaborative Behavioral Management and Integrated parole and outpatient addiction treatment in people with Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Collaborative Behavioral Management and Integrated parole and outpatient addiction treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 420 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2005to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 18 years old and speak English;
- have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II;
- 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;
- must have substance use treatment as a mandated or recommended condition of parole.
Who cannot join
- psychotic features;
- parole or probation conditions that prohibit them from participating in the protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Connecticut Deptartment of Mental Health & Addiction Services
Hartford, Connecticut, 06134
Eleni Rodis, 860-418-6663, Eleni.Rodis@po.state.ct.us
Linda K Frisman, PhD
- Not yet recruiting
University of Kentucky
Lexington, Kentucky, 40536
Conrad J Wong, PhD, 859-323-6774, conrad.wong@uky.edu
Carl G Leukefeld, DSW
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90025
William Burdon, PhD, 310-445-0874 ext. 333, wburdon@ucla.edu
Carter Bartee, BA, 503-241-7145, cbartee@ucla.edu
- Recruiting
University of Delaware
Newark, Delaware, 19716
Daniel J O'Connell, PhD, 302-831-4649, oconnell@UDel.Edu
Steven S. Martin, PhD
- Not yet recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
Anne G Rhodes, MA, 804-827-1160, agrhodes@vcu.ed
Melinda Gales, (804) 628-0646, mgales@mail1.vcu.edu
About this study
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Collaborative Behavioral Management, Integrated parole and outpatient addiction treatment
- Keywords
- Substance-Related Disorders, Prisoners
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Behavioral ManagementBehavioural
Integrated parole and outpatient addiction treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rearrest
Secondary outcomes (1)
Drug use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startFeb 2005
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Investigators
- Peter D Friedmann, MD, MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302575
- Sponsor's protocol ID
- 1U01DA016191
- Status last verified
- Aug 2006
- First submitted
- 13 Mar 2006
- Last updated
- 11 Jan 2017
- Results posted
- No
Publications
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.
PubMed 22175445
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
- ClinicalTrials.gov ID
- NCT00302575
- Acronym / sponsor ID
- 1U01DA016191
- Conditions
- Substance-Related Disorders
- Keywords
- Substance-Related Disorders, Prisoners
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- Feb 2005
- Study completion
- Aug 2007 (estimated)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be at least 18 years old and speak English;
- have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the TCU Drug Screen II;
- 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;
- must have substance use treatment as a mandated or recommended condition of parole.
Key exclusion criteria (2 listed)
- psychotic features;
- parole or probation conditions that prohibit them from participating in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Behavioral Management | Behavioural | – |
| Integrated parole and outpatient addiction treatment | Procedure or surgery | – |
Primary outcome
Rearrest
1 secondary outcome
Drug use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 22175445Friedmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter D Friedmann, MD, MPH principal investigator
Rhode Island Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Behavioral Management and Integrated parole and outpatient addiction treatment in people with Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter D Friedmann, MD, MPH (401-444-3347, pfriedmann@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rearrest. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.