Man Tx: Effects of Manualized Treatment in a Seamless System

• Sponsor: George Mason University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01372033
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 251
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The specific aims of this project are:

1. 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;

2. 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;

3. 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

4. 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.

Condition or Disease	Intervention/Treatment	Phase
Substance Abuse; Offenders; Criminal Thinking; HIV Risk Behaviors	Behavioral: Cognitive Behavioral Therapy; Behavioral: Cognitive Behavioral Therapy	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 251 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effects of Manualized Treatment in a Seamless System of Care: Handling Probation
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT Use of cognitive behavioral therapy focused on social skill development and interpersonal relationships	Behavioral: Cognitive Behavioral Therapy; 18 sessions of CBT, twice weekly; Behavioral: Cognitive Behavioral Therapy; 18 sessions with goals groups drug testing

Outcome Measures

Primary Outcome Measures

1. Arrest [12 months]

Secondary Outcome Measures

1. Treatment Completion [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Substance abusers

• men and women

• treatment

Exclusion Criteria:

• Parolees

• Low threshold substance abuse

• violent offenders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maryland Dvision of Parole and Probation	Baltimore	Maryland	United States	21221

Sponsors and Collaborators

• George Mason University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Faye S Taxman, Ph.D., George Mason University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01372033
• Other Study ID Numbers: R01DA017729; R01DA017729
• First Posted: Jun 13, 2011
• Last Update Posted: Jun 13, 2011
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: drug treatment; substance abuse; offenders; high risk
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

No Results Posted as of Jun 13, 2011