Substance AbuseNCT03826420
Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole
A study testing SCF Supervision with Secure Confinement Sanctioning, SCF Supervision with Work Release Sanctioning and SCF Supervision with GPS Supervision Sanctioning in people with Substance Abuse and Criminal Behavior, run by Botec Analysis, LLC.
Trial summary
This research project will study the outcomes of medium- to high-risk parolees with a history of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair parole. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Criminal Behavior
- What is being tested?
- SCF Supervision with Secure Confinement Sanctioning, SCF Supervision with Work Release Sanctioning and SCF Supervision with GPS Supervision Sanctioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Dec 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Assigned to the Pittsburgh District
- Allegheny County resident
- Has at least 2 years left on supervision
- Had a prior drug or alcohol related sanction
Who cannot join
- Sex offender
- Reentrants assigned to the Special Needs Unit
Trial locations and contacts
No sites are listed yet.
About this study
This research project will study the outcomes of medium- to high-risk parolees with a history of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair parole.
The research goals are to:
- Determine the effectiveness of SCF parole in reducing recidivism among medium- to high-risk parolees with a history of substance abuse in Pennsylvania.
- Determine the minimum effective sanction in response to a violation that will bring parolees into compliance with the conditions of their parole.
- Conditions
- Substance Abuse, Criminal Behavior
- Being tested
- SCF Supervision with Secure Confinement Sanctioning, SCF Supervision with Work Release Sanctioning, SCF Supervision with GPS Supervision Sanctioning
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCF Supervision with Secure Confinement SanctioningBehavioural
Parolees assigned to this group will, in the face of a violation, be given a sanction that involves secure confinement.
SCF Supervision with Work Release SanctioningBehavioural
Parolees assigned to this group will, in the face of a violation, be given a sanction that involves work-release.
SCF Supervision with GPS Supervision SanctioningBehavioural
Parolees assigned to this group will, in the face of a violation, be given a sanction that involves GPS supervision.
| Study group | Role | What they receive |
|---|---|---|
| Secure Confinement Group | Experimental | Parolees assigned to this group will be assigned sanctions that include secure confinement. Receives: Behavioral: SCF Supervision with Secure Confinement Sanctioning |
| Work Release Group | Experimental | Parolees assigned to this group will be assigned sanctions that include work-release. Receives: Behavioral: SCF Supervision with Work Release Sanctioning |
| GPS Supervision Group | Experimental | Parolees assigned to this group will be assigned sanctions that include GPS supervision. Receives: Behavioral: SCF Supervision with GPS Supervision Sanctioning |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revocation Rate
Percentage of subjects in each condition who are revoked from parole and returned to prison
Measured: 9 Months
Secondary outcomes (3)
Days Incarcerated
Total number of days incarcerated in jail or prison per parolee
Measured: 9 Months
New Charges
Number of new charges per parolee
Measured: 9 Months
Percent Positive Drug Tests
Percentage of random and scheduled drug tests that result in a positive reading for illicit drugs
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botec Analysis, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pennsylvania Department of Corrections, Bureau of Justice Assistance
- Responsible party
- Sponsor
- Investigators
- Mark AR Kleiman, Principal investigator, BOTEC Analysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826420
- Sponsor's protocol ID
- BOTEC PADOC SCF
- Status last verified
- Mar 2019
- First submitted
- 30 Jan 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole
- ClinicalTrials.gov ID
- NCT03826420
- Acronym / sponsor ID
- BOTEC PADOC SCF
- Conditions
- Substance Abuse, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Botec Analysis, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pennsylvania Department of Corrections, Bureau of Justice Assistance
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Feb 2019 (actual)
- 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.
This research project will study the outcomes of medium- to high-risk parolees with a history of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair parole.
The research goals are to:
- Determine the effectiveness of SCF parole in reducing recidivism among medium- to high-risk parolees with a history of substance abuse in Pennsylvania.
- Determine the minimum effective sanction in response to a violation that will bring parolees into compliance with the conditions of their parole.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Secure Confinement Group | Experimental | Behavioral: SCF Supervision with Secure Confinement SanctioningParolees assigned to this group will be assigned sanctions that include secure confinement. |
| Work Release Group | Experimental | Behavioral: SCF Supervision with Work Release SanctioningParolees assigned to this group will be assigned sanctions that include work-release. |
| GPS Supervision Group | Experimental | Behavioral: SCF Supervision with GPS Supervision SanctioningParolees assigned to this group will be assigned sanctions that include GPS supervision. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Assigned to the Pittsburgh District
- Allegheny County resident
- Has at least 2 years left on supervision
- Had a prior drug or alcohol related sanction
Key exclusion criteria (2 listed)
- Sex offender
- Reentrants assigned to the Special Needs Unit
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 |
|---|---|---|
| SCF Supervision with Secure Confinement SanctioningParolees assigned to this group will, in the face of a violation, be given a sanction that involves secure confinement. | Behavioural | Secure Confinement Group |
| SCF Supervision with Work Release SanctioningParolees assigned to this group will, in the face of a violation, be given a sanction that involves work-release. | Behavioural | Work Release Group |
| SCF Supervision with GPS Supervision SanctioningParolees assigned to this group will, in the face of a violation, be given a sanction that involves GPS supervision. | Behavioural | GPS Supervision Group |
Primary outcome
Revocation Rate
Time frame: 9 Months
Percentage of subjects in each condition who are revoked from parole and returned to prison
3 secondary outcomes
Days Incarcerated
Time frame: 9 Months
New Charges
Time frame: 9 Months
Percent Positive Drug Tests
Time frame: 9 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mark AR Kleiman principal investigator
BOTEC Analysis
Questions about this trial
What is this clinical trial studying?
A study testing SCF Supervision with Secure Confinement Sanctioning, SCF Supervision with Work Release Sanctioning and SCF Supervision with GPS Supervision Sanctioning in people with Substance Abuse and Criminal Behavior, run by Botec Analysis, LLC.
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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Clarissa Manning ((424) 262-8064, clarissa.manning@botecanalysis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revocation Rate (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2019.