Substance AbuseNCT01381146
Victim Impact Modules for Jail Inmates
A study testing Impact of Crime Modules and TAU in people with Substance Abuse and HIV Risk, run by George Mason University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, HIV Risk, Shame
- What is being tested?
- Impact of Crime Modules and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2016to 15 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- Actively psychotic
- Assigned "keep separate" from other group members
Trial locations and contacts
1 site in 1 country.
United States1 site
Fairfax County Adult Detention Center
Fairfax, Virginia, 22030
About this study
Official title: 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.
- Conditions
- Substance Abuse, HIV Risk, Shame, Guilt, Empathy, Criminogenic Thinking
- Being tested
- Impact of Crime Modules, TAU
- Keywords
- criminal behavior, substance abuse, HIV risk behavior, criminogenic thinking, shame, guilt, empathy, jail inmates, restorative justice, Crime
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Crime ModulesBehavioural
5 session/1 week modules of a restorative justice inspired victim impact group intervention
TAUBehavioural
have access to other jail programs and services
| Study group | Role | What they receive |
|---|---|---|
| Impact of Crime Modules | Experimental | 5 session/1 week modules of a restorative justice inspired victim impact group intervention Receives: Behavioral: Impact of Crime Modules |
| TAU | Other | treatment as usual -- participants have access to all other jail programs and services Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism - Self report of arrests and undetected crimes
Measured: 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
Measured: 1 week post-treatment up to 2 weeks
Number of inmates who complete the intervention
Measured: 5 sessions over a period of 1 week
Secondary outcomes (10)
Self reported Substance use and dependence -Texas Christian University measure
Measured: 3 months post-release up to 9 mos
Self reported HIV risk behavior (sex and Intravenous Drug Use) Texas Christian University measure
Measured: 3 months post-release up to 9 mos
Changes in self-reported Shame-proneness from baseline
Measured: Changes from pre- to post-treatment up to 12 weeks
Changes in self-reported Shame-proneness from baseline
Measured: Changes from pre-treatment to 3 mos post-release up to 9 mos
Changes in self-reported Guilt-proneness from baseline
Measured: Changes from pretreatment to 3 months post-release up to 9 mos
Changes in self-reported Guilt-proneness from baseline
Measured: Changes from pretreatment to post-treatment up to 12 weeks
Changes in self-reported empathy from baseline
Measured: changes from pre- to post-treatment up to 12 weeks
Changes in self-reported empathy from baseline
Measured: changes from pre-treatment to 3 mos post-release up to 9 mos
Changes in self reported criminogenic thinking from baseline
Measured: changes from pre-treatment to post-treatment up to 12 weeks
Changes in self reported criminogenic thinking from baseline
Measured: changes from pre-treatment to 3 mos post-release up to 9 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start15 Jul 2016
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Why it stopped: Results from Phase II Study did not support "dismantling"
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, June Tangney, George Mason University
- Investigators
- June P Tangney, Ph.D., Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381146
- Sponsor's protocol ID
- R01DA014694-12
- Other IDs
- R01DA014694
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2011
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Study of Victim Impact Group Modules for Jail Inmates
- ClinicalTrials.gov ID
- NCT01381146
- Acronym / sponsor ID
- R01DA014694-12
- Conditions
- Substance Abuse, HIV Risk, Shame, Guilt, Empathy, Criminogenic Thinking
- Keywords
- criminal behavior, substance abuse, HIV risk behavior, criminogenic thinking, shame, guilt, empathy, jail inmates
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Results from Phase II Study did not support "dismantling"
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impact of Crime Modules | Experimental | Behavioral: Impact of Crime Modules5 session/1 week modules of a restorative justice inspired victim impact group intervention |
| TAU | Other | Behavioral: TAUtreatment as usual -- participants have access to all other jail programs and services |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Actively psychotic
- Assigned "keep separate" from other group members
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of Crime Modules5 session/1 week modules of a restorative justice inspired victim impact group intervention | Behavioural | Impact of Crime Modules |
| TAUhave access to other jail programs and services | Behavioural | TAU |
Primary outcome
Recidivism - Self report of arrests and undetected crimes
Time frame: 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
Number of inmates who complete the intervention
Time frame: 5 sessions over a period of 1 week
10 secondary outcomes
Self reported Substance use and dependence -Texas Christian University measure
Time frame: 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
Changes in self-reported Shame-proneness from baseline
Time frame: 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 in self-reported Guilt-proneness from baseline
Time frame: 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 in self-reported empathy from baseline
Time frame: 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 in self reported criminogenic thinking from baseline
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June P Tangney, Ph.D. principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact of Crime Modules and TAU in people with Substance Abuse and HIV Risk, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recidivism - Self report of arrests and undetected crimes (time frame: 3 months post-release up to 9 mos). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.