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.
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
- Conditions the study is for
- Usual Aftercare, Oxford House, Therapeutic Community
- 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.
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.
- Conditions
- Usual Aftercare, Oxford House, Therapeutic Community
- 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 group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Aftercare Condition |
| 2 | Experimental | Oxford House Condition Receives: Other: Residential |
| 3 | Experimental | Therapeutic Community Condition Receives: Other: Residential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use
Measured: 2 years from baseline
Secondary outcomes (2)
Criminal Recidivism
Measured: 2 years from baseline
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.
- First posted22 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Usual AftercareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePaul University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Leonard Jason, DePaul University
- Investigators
- Leonard A Jason, Ph.D., Principal investigator, DePaul UniversityDave Mueller, Ph.D., Study director, DePaul University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Alternative Aftercare Models for Ex-Offenders
- ClinicalTrials.gov ID
- NCT00664092
- Acronym / sponsor ID
- LJ070306PSY-C1
- Conditions
- Usual Aftercare, Oxford House, Therapeutic Community
- Keywords
- Substance Abuse, Ex-Offenders, Substance Abuse Recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- DePaul UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Apr 2008 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Aftercare Condition |
| 2 | Experimental | Other: ResidentialOxford House Condition |
| 3 | Experimental | Other: ResidentialTherapeutic Community Condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| ResidentialAlso: Oxford Houseliving in a democratic, resident-run setting | Other | 2 |
| ResidentialAlso: Safe Haven Therapeutic CommunityProfessionally-run substance abuse recovery setting | Other | 3 |
Primary outcome
Substance Use
Time frame: 2 years from baseline
2 secondary outcomes
Criminal Recidivism
Time frame: 2 years from baseline
Health Status
Time frame: 2 years from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
Related trials for Usual Aftercare
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Not yet recruiting
Knee Positioning After Total Knee Replacement
Knee Arthroplasty
Recruiting
R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
Lumbar Radiculopathy, Radicular Low Back Pain
Not yet recruitingPhase 3
Patient-Reported Symptom Care Versus Usual Care After Esophageal Cancer Surgery: A Single-Center Phase 3 Randomized Trial
Esophageal Cancer (EsC)
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.
Leonard A Jason, Ph.D. principal investigator
DePaul University
Dave Mueller, Ph.D. study director
DePaul 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 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.