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Usual AftercarePhase 2NCT00664092

Evaluating Alternative Aftercare Models for Ex-Offenders

A Phase 2 study testing Residential in people with Usual Aftercare and Oxford House, run by DePaul University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this project is to study more closely the role played by post-release aftercare in the outcomes of criminal offenders who received in-prison substance abuse treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Residential
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Oct 2007to Jun 2014
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have completed substance abuse treatment program, or attended 12-step program
  • willing to live in a democratic residential setting, and pay rent
  • Released from a prison or jail in the last 6 months

Who cannot join

  • current substance addict/abuser
  • have previously lived in an Oxford House
  • not planning to go back to their own home or home of a relative following treatment
  • sex offender, fire setter

Trial locations and contacts

1 site in 1 country.

United States1 site
  • DePaul University

    Chicago, Illinois, 60614

Other trials in United States

About this study

The primary aim of this project is to study more closely the role played by post-release aftercare in the outcomes of criminal offenders who received in-prison substance abuse treatment. Prison-based therapeutic communities (TC) (Pelissier et al., 2001; Wexler, 1995) have demonstrated efficacy, especially when combined with post-release TC aftercare (Melnick et al., 2001). The aims of this project are important from a public health perspective as there may be treatment matching, case management, and financing factors that could be manipulated to enhance the cost-effectiveness of community-based substance abuse treatment for offenders leaving prison. It is possible that both TC and Oxford House(OH) aftercare modalities increase abstinence social support, self-efficacy, and employment, which mediate reductions in drug use, reincarceration, and health problems, but overall benefits are likely to be greater for TCs because they employ professional services and empirically based behavioral strategies. However, OHs might have advantages compared to more traditional post-incarceration modalities (e.g., low costs). Bringing scientific methods to the examination of TCs and the OH community-based recovery models for addiction might help to identify the "active ingredients" of these recovery settings.

Read the detailed description

The primary aim of this project is to study more closely the role played by post-release aftercare in the outcomes of criminal offenders who received in-prison substance abuse treatment. Prison-based therapeutic communities (TC) (Pelissier et al., 2001; Wexler, 1995) have demonstrated efficacy, especially when combined with post-release TC aftercare (Melnick et al., 2001). For example, Inciardi et al. (2003) showed that TC aftercare substantially reduced criminal behavior and significantly decreased illicit drug use when compared to outcomes for inmates who dropped out of prison TC care or graduated prison TC, but who did not enter or remain long in TC aftercare. Moreover, some released TC participants may prefer and feel that they are ready for a less-structured environment than TC aftercare.

Several important questions relevant to public health issues remain unclear in the scientific literature regarding prison TC aftercare. The answers might help establish more enlightened post-release aftercare policy affecting prison inmates. For example, it is unclear whether the main therapeutic effect of TC aftercare is TC substance abuse treatment or the supportive residential setting. Typically, TC aftercare outcomes for prison TC graduates are compared to aftercare-as-usual, which can range across a wide variety of interventions. Few if any comparison groups have included a residential setting that emphasizes socialization and abstinence from drugs and alcohol - a hallmark of TC aftercare settings. This study proposes to compare the relative effectiveness of TC aftercare to an aftercare alternative that provides a supportive living environment without the professional treatment of TC aftercare. Oxford Houses (OH) provide, like TCs, a residential post-release setting that emphasizes socialization and abstinence from drugs and alcohol, but they do not include the formal therapeutic change interventions common to TCs, nor do they include any on-site access to drug abuse or health care professionals. Such a comparison will possibly clarify the value added of TC aftercare intervention processes not present in OHs.

The aims of this project are important from a public health perspective as there may be treatment matching, case management, and financing factors that could be manipulated to enhance the cost-effectiveness of community-based substance abuse treatment for offenders leaving prison. It is possible that both TC and OH aftercare modalities increase abstinence social support, self-efficacy, and employment, which mediate reductions in drug use, reincarceration, and health problems, but overall benefits are likely to be greater for TCs because they employ professional services and empirically based behavioral strategies. However, OHs might have advantages compared to more traditional post-incarceration modalities (e.g., low costs). Bringing scientific methods to the examination of TCs and the OH community-based recovery models for addiction might help to identify the "active ingredients" of these recovery settings. The proposed study will utilize ex-offenders randomly assigned to either TCs, OHs, or usual care post-release settings, and examine program effects (i.e., substance use, criminal and health outcomes), and economic factors associated with these models. A research finding from a study that contrasts these different approaches has the potential to influence practice and inform policy.

Several theoretically based hypotheses include:

TCs and OHs in comparison to usual aftercare will have less substance use, less criminal recidivism, and better health outcomes. TCs are expected to have better outcomes than OHs on these measures, due to the professionally structured and inpatient nature of TC.

Factors related to the programs (i.e., abstinence social support, self-efficacy, employment) will mediate the differential outcomes. For example, due to the inpatient nature of TCs and the requirement for employment to remain in OH, OH residents are expected to have more employment and earnings during the first year. However, these differences are expected to converge at 18 and 24 months. Usual aftercare should reflect the lowest employment and earning relative to TC and OH for all time periods.

The long term post release outcomes will be moderated by gender, ethnicity, substance abuse (i.e., severity and typology), and in-prison treatment (i.e., in prison TC fidelity, days in prison TC).

Although outcomes overall are expected to be best for TC, followed by OH and usual aftercare, we expect the cost-benefit ratios to be most favorable for OH, followed by TC, with the lowest cost benefit ratio for usual aftercare.

Being tested
Residential
Keywords
Substance Abuse, Ex-Offenders, Substance Abuse Recovery
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.

  • ResidentialOther

    Also called Oxford House

    living in a democratic, resident-run setting

  • ResidentialOther

    Also called Safe Haven Therapeutic Community

    Professionally-run substance abuse recovery setting

Study groups in NCT00664092
Study groupRoleWhat they receive
1No interventionUsual Aftercare Condition
2ExperimentalOxford House Condition
Receives: Other: Residential
3ExperimentalTherapeutic Community Condition
Receives: Other: Residential

What is being measured

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

  1. Substance Use

    Measured: 2 years from baseline

Secondary outcomes (2)
  1. Criminal Recidivism

    Measured: 2 years from baseline

  2. Health Status

    Measured: 2 years from baseline

Timeline

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

  1. First posted22 Apr 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJun 2014
  4. Study completionJun 2014

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Care provider
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00664092
Sponsor's protocol ID
LJ070306PSY-C1
Other IDs
5R01DA019935-03
Status last verified
Feb 2015
First submitted
18 Apr 2008
Last updated
11 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Residential in people with Usual Aftercare and Oxford House, run by DePaul 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 11 Feb 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Substance Use (time frame: 2 years from baseline). 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 11 Feb 2015.

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