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CrimePhase 1/2IOC-1NCT01380977

Trial of Impact of Crime Group Intervention for Jail Inmates

A Phase 1/2 study testing Impact of Crime group intervention in people with Crime and Substance Abuse, run by George Mason University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This pilot study is designed to evaluate the efficacy of the Impact of Crime (IOC) group intervention for jail inmates. The hypothesis is that participants in IOC will show decreases in criminogenic thinking, decreases in shame, increases in guilt, and increases in empathy, which in turn will be reflected in reduced… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Crime, Substance Abuse, HIV Risk
What is being tested?
Impact of Crime group intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Aug 2002to Jul 2016
Phase
Phase 1/2
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
  • No healthy volunteers
  • 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
  • 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

Other trials in United States

About this study

This pilot study is designed to evaluate the efficacy of the Impact of Crime (IOC) group intervention for jail inmates. The hypothesis is that participants in IOC will show decreases in criminogenic thinking, decreases in shame, increases in guilt, and increases in empathy, which in turn will be reflected in reduced recidivism (official records and self report), relative to those randomly assigned to a treatment as usual group.

Being tested
Impact of Crime group intervention
Keywords
crime, substance abuse, HIV risk, criminogenic thinking, shame, guilt, restorative justice, victim impact group
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impact of Crime group interventionBehavioural

    A group intervention for 16 1.5 hr sessions held twice a week

Study groups in NCT01380977
Study groupRoleWhat they receive
Impact of Crime group interventionExperimentalNot described
Receives: Behavioral: Impact of Crime group intervention
Treatment as usualActive comparatorNot described
Receives: Behavioral: Impact of Crime group intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self reported recidivism (arrests and undetected offenses)

    Measured: 1 year post-release up to 2 yrs post release

  2. Self reported recidivism (arrests and undetected offenses)

    Measured: 4 years post-release up to 5 yrs post release

  3. Self reported recidivism (arrests and undetected offenses)

    Measured: 7 years post-release up to 8 yrs post-release

  4. Self reported recidivism (arrests and undetected offenses)

    Measured: 10 years post-release up to 11 yrs post-release

  5. Self-reported Substance Use and Dependence - TCU

    Measured: 1 year post-release up to 2 yrs post-release

  6. Self-reported Substance Use and Dependence - TCU

    Measured: 4 years post-release up to 5 yrs post-release

  7. Self-reported Substance Use and Dependence - TCU

    Measured: 7 years post-release up to 8 yrs post-release

  8. Self-reported Substance Use and Dependence - TCU

    Measured: 10 years post-release up to 11 yrs post release

  9. Self-reported HIV risk behaviors (sex and IDU) - TCU

    Measured: 1 year post-release - up to 2 yrs post-release

  10. Self-reported HIV risk behaviors (sex and IDU) - TCU

    Measured: 4 years post-release up to 5 yrs post-release

  11. Self-reported HIV risk behaviors (sex and IDU) - TCU

    Measured: 7 years post-release up to 8 yrs post-release

  12. Self-reported HIV risk behaviors (sex and IDU) - TCU

    Measured: 10 years post-release up to 11 yrs post-release

Secondary outcomes (24)

  1. Changes from baseline in Self reported criminogenic beliefs - CCS

    Measured: Baseline to post-treatment up to 9 mos

  2. Changes from baseline in Self reported criminogenic beliefs - CCS

    Measured: Baseline to pre-release up to 1.5 yrs

  3. Changes from baseline in Self reported criminogenic beliefs - CCS

    Measured: Baseline to 1 yr post-release up to 3.5 yrs

  4. Changes from baseline in Self reported criminogenic beliefs - CCS

    Measured: Baseline to 4 yrs post-release up to 6.5 yrs

  5. Changes from baseline in Self reported criminogenic beliefs - CCS

    Measured: Baseline to 7 yrs post-release up 9,5 yrs

  6. Changes from baseline in Self reported criminogenic beliefs - CCS

    Measured: Baseline to 10 yrs post-release up to 12.5 yrs

  7. Changes from baseline in self-reported shame - TOSCA-SD

    Measured: Baseline to post-treatment up to 9 mos

  8. Changes from baseline in self-reported shame - TOSCA-SD

    Measured: Baseline to pre-release up to 1.5 yrs

  9. Changes from baseline in self-reported shame - TOSCA-SD

    Measured: Baseline to 1 yr post release up to 3.5 yrs

  10. Changes from baseline in self-reported shame - TOSCA-SD

    Measured: Baseline to 4 yrs post release up to 6.5 yrs

  11. Changes from baseline in self-reported shame - TOSCA-SD

    Measured: Baseline to 7 yrs post release up to 9.5 yrs

  12. Changes from baseline in self-reported shame - TOSCA-SD

    Measured: Baseline to 10 yrs post release up to 12.5 yrs

  13. Changes from baseline in self-reported Guilt - TOSCA-SD

    Measured: Baseline to post-treatment up to 9 mos

  14. Changes from baseline in self-reported Guilt - TOSCA-SD

    Measured: Baseline to pre-release up to 1.5 yrs

  15. Changes from baseline in self-reported Guilt - TOSCA-SD

    Measured: Baseline to 1 yr post-release up to 3.5 yrs

  16. Changes from baseline in self-reported Guilt - TOSCA-SD

    Measured: Baseline to 4 yrs post-release up to 6.5 yrs

  17. Changes from baseline in self-reported Guilt - TOSCA-SD

    Measured: Baseline to 7 yrs post-release up to 9.5 yrs

  18. Changes from baseline in self-reported Guilt - TOSCA-SD

    Measured: Baseline to 10 yrs post-release up to 12.5 yrs

  19. Changes from baseline in self-reported Empathy - IRI

    Measured: Baseline to post-treatment up to 9 mos

  20. Changes from baseline in self-reported Empathy - IRI

    Measured: Baseline to pre-release up to 1.5 yrs

  21. Changes from baseline in self-reported Empathy - IRI

    Measured: Baseline to 1 year post-release up to 3.5 yrs

  22. Changes from baseline in self-reported Empathy - IRI

    Measured: Baseline to 4 years post-release up to 6.5 yrs

  23. Changes from baseline in self-reported Empathy - IRI

    Measured: Baseline to 7 years post-release up to 9.5 yrs

  24. Changes from baseline in self-reported Empathy - IRI

    Measured: Baseline to 10 years post-release up to 12.5 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startAug 2002
  3. Primary completionAug 2013 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01380977
Sponsor's protocol ID
R01DA014694-1
Other IDs
R01DA014694
Acronym
IOC-1
Status last verified
May 2013
First submitted
21 Jun 2011
Last updated
7 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Impact of Crime group intervention in people with Crime and Substance Abuse, 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 6 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Self reported recidivism (arrests and undetected offenses) (time frame: 1 year post-release up to 2 yrs post release). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01380977.

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.

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