An Evaluation of the NJSPB SCF Project for Opioid-Involve... | NCT03812484

Studies
An Evaluation of the NJSPB SCF Project for Opioid-Involved High-Risk Parolees

NCT03812484

Sponsor

Botec Analysis, LLC

Status

Unknown status

Last Update Posted

Feb 2, 2021Actual

Enrollment

77Actual

Phase

Not Applicable

Conditions

Substance Abuse
Criminal Behavior

Interventions

SCF Supervision
Parole-as-Usual

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Mar 31, 2021Estimated

First Submitted Date

Jan 17, 2019

First Submission Date that Met QC Criteria

Jan 18, 2019

First Posted Date

Jan 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Clarissa Manning, Director of Business Operations, Botec Analysis, LLCPrincipal Investigator

Lead Sponsor

Botec Analysis, LLCINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU).

Detailed Description

The Swift, Certain, and Fair (SCF) Supervision Program - Including Project HOPE Program provides funding to states, units of local government, territories, and federally recognized Indian tribes (as determined by the Secretary of the Interior) in an effort to enhance public safety, foster collaboration, and to improve the outcomes of individuals under the supervision of community corrections. The goals of this program are to develop and enhance SCF initiatives and implement the SCF model with fidelity, resulting in reduced recidivism and better outcomes for program participants. SCF approaches are intended to: (a) improve supervision strategies that reduce recidivism; (b) promote and increase collaboration among agencies and officials who work in community corrections and related fields to enhance swift and certain sanctions; (c) enhance the offenders' perception that the supervision decisions are fair, consistently applied, and consequences are transparent; and (d) improve the outcomes of individuals participating in these initiatives. The grantee will use awarded grant funds to support programming that provides services to up to 75 opioid involved parolees with services to divert them from a return to prison and manage underlying addictions with a combination of behavioral therapy and medication assisted treatments. The program combines sanctions with targeted reentry and treatment services.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCF Parole	Experimental	Parolee supervised under the SCF Supervision model	Behavioral: SCF Supervision
Parole-As-Usual	Active Comparator	Parolees are supervised under standard parole supervision practice in New Jersey.	Behavioral: Parole-as-Usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCF Supervision	Behavioral	SCF Supervision entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). SCF Supervision includes regular random drug testing.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Revocation Rate	Percentage of subjects in each condition who are revoked from parole and returned to prison	12 months

Secondary Outcomes

Measure	Description	Time Frame
Days Incarcerated	Total number of days incarcerated in jail or prison	12 months
New Charges	Number of new charges	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be 18 years of age or older
Participants must have a history of opioid use or addiction
Participants have a history of parole violations or active parolees who are at risk for violation (this can include anyone who is reentering the active population from prison)
Participants reside in or are moving to Ocean County; and
Participants must have at least 6 months remaining on their Parole term

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clarissa Manning, MPP	Botec Analysis, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Jersey Reentry Corporation		Toms River	New Jersey	08753	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D000066479	Criminal Behavior

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided