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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01378936
Other study ID # R01DA014694-11
Secondary ID R01DA014694
Status Active, not recruiting
Phase Phase 2
First received June 17, 2011
Last updated May 3, 2013
Start date August 2009
Est. completion date June 2016

Study information

Verified date May 2013
Source George Mason University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether the Impact of Crime (IOC) group intervention with jail inmates reduces post-release recidivism, substance abuse, and HIV risk behavior.


Description:

This project imports social-personality theory and research on moral emotions and cognitions to the applied problems of crime, substance abuse, and HIV risk behavior. The primary aim of this study, a Phase 2 Randomized Clinical Trial (RCT) of the restorative justice-inspired Impact of Crime (IOC) group intervention, is to examine the efficacy of treatment and to determine if changes in moral emotions and cognitions serve as mechanisms of action, explaining the impact of treatment involvement on reductions in post-release recidivism, substance abuse, and HIV risk behavior.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date June 2016
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be 18 years or older

- Must be male

- Must be currently incarcerated jail inmate

- Must be sentenced

- Sentence must be short enough to serve out sentence at ADC

- Release date must follow projected final session of treatment

- Must speak, read, and write in English with sufficient proficiency to use workbook and participate in group sessions

- Must be assigned to the jail's "general population"

Exclusion Criteria:

- Actively psychotic

- Assigned "keep separate" from other group members

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
MI plus IOC group intervention
45 minute Motivational Interview plus 16 session IOC intervention
Motivational Interview only
45 minute Motivational Interview session

Locations

Country Name City State
United States Fairfax County Adult Detention Center Fairfax Virginia

Sponsors (2)

Lead Sponsor Collaborator
George Mason University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recidivism - Self report of arrests and undetected crimes 3 months post-release No
Primary Recidivism - Self report of arrests and undetected crimes 1 yr post-release No
Primary Recidivism - Self report of arrests and undetected crimes 3 yr post-release No
Primary Recidivism - Self report of arrests and undetected crimes 5 yr post-release No
Primary Recidivism -- official FBI records of arrests 1 yr post-release No
Primary Recidivism -- official FBI records of arrests 3 yr post-release No
Primary Recidivism -- official FBI records of arrests 5 yr post-release No
Secondary Changes in self-reported shame-proneness from baseline changes from baseline to post tx and 3 mo, 1 yr, 3yr and 5 yr post-release No
Secondary Changes in self-reported guilt proneness from baseline changes from baseline to post tx, and 3 mo, 1 yr, 3 yr, 5 yr post-release No
Secondary Changes from self-reported empathy from baseline changes from baseline to post tx, 3 mo, 1 yr, 3 yr, 5 yr post-release No
Secondary Changes from self-reported criminogenic thinking at baseline changes from baseline to post tx, and 3 mo, 1 yr, 3 yr, 5 yr post-release No
Secondary Changes in self-reported substance use and dependence from 1 yr pre-incarceration changes from pre-incarceration to 3 mo, 1 yr, 3 yr, 5 yr post-release No
Secondary Changes in self-reported HIV risk behavior (sex and IDU) from 1 year pre-incarceration changes from pre-incarceration to 3 mo, 1 yr, 3 yr, 5 yr post-release No
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