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Effects of Manualized Treatment in a Seamless System (Man Tx)

Primary Purpose

Substance Abuse, Offenders, Criminal Thinking

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Abuse focused on measuring drug treatment, substance abuse, offenders, high risk

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Substance abusers

    • men and women
    • treatment

Exclusion Criteria:

  • Parolees

    • Low threshold substance abuse
    • violent offenders

Sites / Locations

  • Maryland Dvision of Parole and Probation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT

Arm Description

Use of cognitive behavioral therapy focused on social skill development and interpersonal relationships

Outcomes

Primary Outcome Measures

Arrest

Secondary Outcome Measures

Treatment Completion

Full Information

First Posted
June 10, 2011
Last Updated
June 10, 2011
Sponsor
George Mason University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01372033
Brief Title
Effects of Manualized Treatment in a Seamless System
Acronym
Man Tx
Official Title
Effects of Manualized Treatment in a Seamless System of Care: Handling Probation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
George Mason University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aims of this project are: To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders; To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level; To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Offenders, Criminal Thinking, HIV Risk Behaviors
Keywords
drug treatment, substance abuse, offenders, high risk

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
Use of cognitive behavioral therapy focused on social skill development and interpersonal relationships
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
18 sessions of CBT, twice weekly
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
18 sessions with goals groups drug testing
Primary Outcome Measure Information:
Title
Arrest
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment Completion
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Substance abusers men and women treatment Exclusion Criteria: Parolees Low threshold substance abuse violent offenders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faye S Taxman, Ph.D.
Organizational Affiliation
George Mason University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Dvision of Parole and Probation
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21221
Country
United States

12. IPD Sharing Statement

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Effects of Manualized Treatment in a Seamless System

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