Victim Impact Modules for Jail Inmates

April 21, 2017 updated by: June Tangney, George Mason University

Phase 1-2 Study of Victim Impact Group Modules for Jail Inmates

The purpose of this study is to evaluate feasibility of modularized delivery of the Impact of Crime (IOC) group intervention with jail inmates, and obtain preliminary data on its effectiveness in reducing post-release recidivism, substance abuse, and HIV risk behavior.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Fairfax County Adult Detention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Impact of Crime Modules
5 session/1 week modules of a restorative justice inspired victim impact group intervention
Behavioral: Impact of Crime Modules
5 session/1 week modules of a restorative justice inspired victim impact group intervention
Other: TAU
treatment as usual -- participants have access to all other jail programs and services
Behavioral: TAU
have access to other jail programs and services

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Recidivism - Self report of arrests and undetected crimes
Time Frame: 3 months post-release up to 9 mos
3 months post-release up to 9 mos
Acceptability - number of participants who indicate the module was helpful and number who would recommend treatment to a friend
Time Frame: 1 week post-treatment up to 2 weeks
1 week post-treatment up to 2 weeks
Number of inmates who complete the intervention
Time Frame: 5 sessions over a period of 1 week
5 sessions over a period of 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Self reported Substance use and dependence -Texas Christian University measure
Time Frame: 3 months post-release up to 9 mos
3 months post-release up to 9 mos
Self reported HIV risk behavior (sex and Intravenous Drug Use) Texas Christian University measure
Time Frame: 3 months post-release up to 9 mos
3 months post-release up to 9 mos
Changes in self-reported Shame-proneness from baseline
Time Frame: Changes from pre- to post-treatment up to 12 weeks
Changes from pre- to post-treatment up to 12 weeks
Changes in self-reported Shame-proneness from baseline
Time Frame: Changes from pre-treatment to 3 mos post-release up to 9 mos
Changes from pre-treatment to 3 mos post-release up to 9 mos
Changes in self-reported Guilt-proneness from baseline
Time Frame: Changes from pretreatment to 3 months post-release up to 9 mos
Changes from pretreatment to 3 months post-release up to 9 mos
Changes in self-reported Guilt-proneness from baseline
Time Frame: Changes from pretreatment to post-treatment up to 12 weeks
Changes from pretreatment to post-treatment up to 12 weeks
Changes in self-reported empathy from baseline
Time Frame: changes from pre- to post-treatment up to 12 weeks
changes from pre- to post-treatment up to 12 weeks
Changes in self-reported empathy from baseline
Time Frame: changes from pre-treatment to 3 mos post-release up to 9 mos
changes from pre-treatment to 3 mos post-release up to 9 mos
Changes in self reported criminogenic thinking from baseline
Time Frame: changes from pre-treatment to post-treatment up to 12 weeks
changes from pre-treatment to post-treatment up to 12 weeks
Changes in self reported criminogenic thinking from baseline
Time Frame: changes from pre-treatment to 3 mos post-release up to 9 mos
changes from pre-treatment to 3 mos post-release up to 9 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Mason University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: June P Tangney, Ph.D., George Mason University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DA014694-12 (U.S. NIH Grant/Contract)
  • R01DA014694 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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