Substance AbusePhase 2IOCNCT01378936
Jail-Based Impact of Crime Intervention
A Phase 2 study testing MI plus IOC group intervention and Motivational Interview only 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 whether the Impact of Crime (IOC) group intervention with jail inmates reduces 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, Criminogenic Thinking
- What is being tested?
- MI plus IOC group intervention and Motivational Interview only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2016
- Phase
- Phase 2
- 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 2 RCT of Jail-Based Impact of Crime Intervention to Reduce Recidivism, Substance Abuse and HIV Risk Behavior
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.
Read the detailed 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.
- Conditions
- Substance Abuse, HIV Risk, Criminogenic Thinking, Shame, Guilt, Empathy
- Being tested
- MI plus IOC group intervention, Motivational Interview only
- 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.
MI plus IOC group interventionBehavioural
Also called Impact of Crime
45 minute Motivational Interview plus 16 session IOC intervention
Motivational Interview onlyBehavioural
45 minute Motivational Interview session
| Study group | Role | What they receive |
|---|---|---|
| MI plus IOC group intervention | Experimental | Not described Receives: Behavioral: MI plus IOC group intervention |
| Motivational Interview only | Experimental | Not described Receives: Behavioral: Motivational Interview only |
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
Recidivism - Self report of arrests and undetected crimes
Measured: 1 yr post-release
Recidivism - Self report of arrests and undetected crimes
Measured: 3 yr post-release
Recidivism - Self report of arrests and undetected crimes
Measured: 5 yr post-release
Recidivism -- official FBI records of arrests
Measured: 1 yr post-release
Recidivism -- official FBI records of arrests
Measured: 3 yr post-release
Recidivism -- official FBI records of arrests
Measured: 5 yr post-release
Secondary outcomes (6)
Changes in self-reported shame-proneness from baseline
Measured: changes from baseline to post tx and 3 mo, 1 yr, 3yr and 5 yr post-release
Changes in self-reported guilt proneness from baseline
Measured: changes from baseline to post tx, and 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes from self-reported empathy from baseline
Measured: changes from baseline to post tx, 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes from self-reported criminogenic thinking at baseline
Measured: changes from baseline to post tx, and 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes in self-reported substance use and dependence from 1 yr pre-incarceration
Measured: changes from pre-incarceration to 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes in self-reported HIV risk behavior (sex and IDU) from 1 year pre-incarceration
Measured: changes from pre-incarceration to 3 mo, 1 yr, 3 yr, 5 yr post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2013 (estimated)
- Study completionJun 2016 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
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
- NCT01378936
- Sponsor's protocol ID
- R01DA014694-11
- Other IDs
- R01DA014694
- Acronym
- IOC
- Status last verified
- May 2013
- First submitted
- 17 Jun 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 RCT of Jail-Based Impact of Crime Intervention to Reduce Recidivism, Substance Abuse and HIV Risk Behavior
- ClinicalTrials.gov ID
- NCT01378936
- Acronym / sponsor ID
- IOC / R01DA014694-11
- Conditions
- Substance Abuse, HIV Risk, Criminogenic Thinking, Shame, Guilt, Empathy
- Keywords
- criminal behavior, substance abuse, HIV risk behavior, criminogenic thinking, shame, guilt, empathy, jail inmates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 23 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 whether the Impact of Crime (IOC) group intervention with jail inmates reduces post-release recidivism, substance abuse, and HIV risk behavior.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI plus IOC group intervention | Experimental | Behavioral: MI plus IOC group intervention |
| Motivational Interview only | Experimental | Behavioral: Motivational Interview only |
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 |
|---|---|---|
| MI plus IOC group interventionAlso: Impact of Crime45 minute Motivational Interview plus 16 session IOC intervention | Behavioural | MI plus IOC group intervention |
| Motivational Interview only45 minute Motivational Interview session | Behavioural | Motivational Interview only |
Primary outcome
Recidivism - Self report of arrests and undetected crimes
Time frame: 3 months post-release
Recidivism - Self report of arrests and undetected crimes
Time frame: 1 yr post-release
Recidivism - Self report of arrests and undetected crimes
Time frame: 3 yr post-release
Recidivism - Self report of arrests and undetected crimes
Time frame: 5 yr post-release
Recidivism -- official FBI records of arrests
Time frame: 1 yr post-release
Recidivism -- official FBI records of arrests
Time frame: 3 yr post-release
Recidivism -- official FBI records of arrests
Time frame: 5 yr post-release
6 secondary outcomes
Changes in self-reported shame-proneness from baseline
Time frame: changes from baseline to post tx and 3 mo, 1 yr, 3yr and 5 yr post-release
Changes in self-reported guilt proneness from baseline
Time frame: changes from baseline to post tx, and 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes from self-reported empathy from baseline
Time frame: changes from baseline to post tx, 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes from self-reported criminogenic thinking at baseline
Time frame: changes from baseline to post tx, and 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes in self-reported substance use and dependence from 1 yr pre-incarceration
Time frame: changes from pre-incarceration to 3 mo, 1 yr, 3 yr, 5 yr post-release
Changes in self-reported HIV risk behavior (sex and IDU) from 1 year pre-incarceration
Time frame: changes from pre-incarceration to 3 mo, 1 yr, 3 yr, 5 yr post-release
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
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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 Phase 2 study testing MI plus IOC group intervention and Motivational Interview only 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: status not confirmed, as of the sponsor's last update on 7 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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). The study lists 7 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 7 May 2013.