Substance UseNCT01670708
HOPE Demonstration Field Experiment Multisite Evaluation
A study testing HOPE and Probation as Usual in people with Substance Use and Criminal Recidivism, run by RTI International at 4 sites in United States.
Trial summary
The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control trial (RCT) replication of the original Hawaii HOPE program and evaluation. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Criminal Recidivism
- What is being tested?
- HOPE and Probation as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,504 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2012to 31 Mar 2015
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult probationers assessed as high risk for failure on probation (e.g., high likelihood of new arrest, failure to comply with conditions) who live within the geographic boundaries of the study site with at least 11.5 months remaining on their probation sentence
Who cannot join
- Juveniles
- live outside geographic boundaries
- assigned to specialized probation caseloads (e.g., sex offender, DUI, mental health)
- non-English speaking in some sites
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Court and Probation Office, Saline County
Benton, Arkansas
Court and Probation Office, Tarrant County
Fort Worth, Texas
Court and Probation Office
Oregon City, Oregon
Salem County Probation Office, Massachusetts Salem District Court, Essex County Superior Court
Salem, Massachusetts
About this study
Official title: Multisite Evaluation of the Honest Opportunity With Enforcement Demonstration Field Experiment
The purpose of the Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program provides strict oversight of probationers through a HOPE Court judge and intensive probation supervision, including random drug testing, coupled with swift and certain sanctions in response to positive results on random drug tests and other violations of conditions of supervision. The HOPE DFE Evaluation is being conducted among probation populations in four sites and will identify the effectiveness of swift and certain sanctions on targeted outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and secondary (revocation rates, jail days served, prison days sentenced).
Read the detailed description
The Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration Field Experiment (the HOPE DFE Evaluation) has four goals: (1) Design and implement a randomization process in each of the four DFE sites; (2) Conduct a comprehensive process evaluation to assess implementation fidelity and identify lessons learned that will enhance future replications; (3) Conduct a rigorous experimental outcome evaluation to determine the effect of the HOPE model and its components on individual probation outcomes; and (4) Conduct a cost evaluation to assess the cost effectiveness of HOPE. The RCT will involve identifying in each of four sites a pool of HOPE-eligible probationers who will be randomly assigned to HOPE or to probation as usual (PAU). The evaluation will randomly assign approximately 400 eligible probationers to HOPE or PAU in each of the four sites for a total sample size of 1,600 (800 HOPE and 800 PAU). Criteria identifying the HOPE-eligible target population and procedures to identify that population in a timely fashion randomly assigning HOPE-eligible Probationers to HOPE or PAU have been identified. Random assignment will be accomplished using evaluation-provided forms that include study identification numbers and the random assignment that is covered by a scratch-off label. The assignment will be revealed only after the individual has been provided the opportunity to participate in the evaluation and, with consent, completed the baseline interview. The process evaluation/fidelity assessment component will document the extent to which each program conforms to the HOPE model; document the barriers, challenges, facilitators, and lessons learned during implementation to fill gaps in the knowledge base as to what is required to set up a HOPE program; and provide evidence as to the generalizability and sustainability of HOPE programs. This component will also document the PAU control conditions in each site and will assess implementation fidelity of evidence-based drug treatment programs. Implementation and process measures will be collected through stakeholder interviews; observation of initial warning hearings and court appearances; and review of court, probation, and HOPE project records. The process evaluation will also document the PAU practices to identify intervention differences among the control groups and to provide an opportunity to measure changes in practices that could signal contamination of the control arm. Fidelity assessments of drug treatment programs will be conducted using the Correctional Program Checklist. The outcome study will assess whether HOPE participation improves appointment compliance, drug test results, rearrest rates, revocation rates, jail days served, and prison days sentenced. In addition, the evaluation will determine whether HOPE participation changes potential mediators including criminal thinking/attitudes, perceptions of control and justice system fairness and legitimacy, dynamic recidivism risk factors, and employment and housing stability. For the outcome study, administrative data will provide information on appointment compliance, drug test results, re-arrests, violations, revocations, and jail and prison days for all HOPE and PAU evaluation participants. Interview data will be collected from evaluation participants at evaluation enrollment and 6 months post-enrollment on measures that will facilitate understanding of the nature of individual change associated with HOPE participation. All HOPE-eligible Probationers who consent to study participation will complete an audio computer assisted self interview (ACASI) at baseline and 6 months post baseline; a random sample of those completing ACASI baseline interviews will be asked to participate in a twice-weekly series of mini-interviews (telephone-ACASI or T-ACASI). Non-incarcerated individuals are being offered $20 equivalent to complete the ACASI interview. Random drug tests on a subsample of HOPE and PAU evaluation participants will be conducted in conjunction with the 6-month post-enrollment interviews to provide a common measure of current drug use.
- Conditions
- Substance Use, Criminal Recidivism
- Being tested
- HOPE, Probation as Usual
- Keywords
- Substance Use, Illicit Drug Use, Criminal Behavior
- Medical subject headings
- Substance-Related Disorders, Recidivism, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPEBehavioural
HOPE Court Judge provides warning hearing; random drug testing; violation hearing and jail/other sanctions for failed drug test or failure to comply with other probation conditions.
Probation as UsualBehavioural
Probation officer supervises following standard protocols.
| Study group | Role | What they receive |
|---|---|---|
| HOPE | Experimental | Participation in HOPE program Receives: Behavioral: HOPE |
| Probation as Usual | Active comparator | Participation in probation as usual Receives: Behavioral: Probation as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illegal drug use
Multiple measures to include percent positive for (1) marijuana, (2) cocaine, (3) heroin, (4) methamphetamine, and (5) any illegal drug on an oral swab drug test administered in conjunction with the 6 month follow-up interview (subjects in the community, i.e. not jailed or institutionalized, only).
Measured: 6 months
Rearrest
Multiple measures to include (1) percent arrested within 6 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 6 months of baseline; and (5) percent arrested for (a) violent, and (b) property
Measured: 6 Months
Rearrest
Multiple measures to include (1) percent arrested within 12 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 12 months of baseline; and (5) percent arrested for (a) violent, (b) property, and (c) drug offenses within 12 months of baseline.
Measured: 12 months
Probation Appointment Compliance
Number of missed appointments following baseline.
Measured: 6 months
Probation Appointment Compliance
Number of missed appointments following baseline.
Measured: 12 months
Secondary outcomes (6)
Probation revocation
Percent revoked from probation within 6 months following baseline.
Measured: 6 months
jail days served
Number of days served in jail within 6 months following baseline for (1) violation of conditions of probation; (2) arrest or charge for new offense; (3) sentence for new offense; and (4) total number of days.
Measured: 6 months
Probation Revocation
Percent revoked from probation within 12 months following baseline.
Measured: 12 Months
Jail Days Served
Number of days served in jail within 12 months following baseline for (1) violation of conditions of probation; (2) arrest or charge for new offense; (3) sentence for new offense; and (4) total number of days.
Measured: 12 months
Prison Days Sentenced
Number of days sentenced to prison within 6 months following baseline for (1) probation revocation; (2) conviction for a new offense; and (3) total of revocation and new conviction.
Measured: 6 months
Prison Days Sentenced
Number of days sentenced to prison within 12 months following baseline for (1) probation revocation; (2) conviction for a new offense; and (3) total of revocation and new conviction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Pamela K Lattimore, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670708
- Sponsor's protocol ID
- 2011-RY-BX-0003
- Status last verified
- Dec 2017
- First submitted
- 7 Aug 2012
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Evaluation of the Honest Opportunity With Enforcement Demonstration Field Experiment
- ClinicalTrials.gov ID
- NCT01670708
- Acronym / sponsor ID
- 2011-RY-BX-0003
- Conditions
- Substance Use, Criminal Recidivism
- Keywords
- Substance Use, Illicit Drug Use, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Penn State University, U.S. Department of Justice
- Study start
- Aug 2012 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 22 Aug 2012 (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 the Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration Field Experiment (the HOPE DFE Evaluation) is to conduct a randomized control trial (RCT) replication of the original Hawaii HOPE program and evaluation. The HOPE program provides strict oversight of probationers through a HOPE Court judge and intensive probation supervision, including random drug testing, coupled with swift and certain sanctions in response to positive results on random drug tests and other violations of conditions of supervision. The HOPE DFE Evaluation is being conducted among probation populations in four sites and will identify the effectiveness of swift and certain sanctions on targeted outcomes, both primary (appointment no-shows, positive urine tests, re-arrest rates) and secondary (revocation rates, jail days served, prison days sentenced).
Detailed description
The Multisite Evaluation of the Honest Opportunity Probation with Enforcement Demonstration Field Experiment (the HOPE DFE Evaluation) has four goals: (1) Design and implement a randomization process in each of the four DFE sites; (2) Conduct a comprehensive process evaluation to assess implementation fidelity and identify lessons learned that will enhance future replications; (3) Conduct a rigorous experimental outcome evaluation to determine the effect of the HOPE model and its components on individual probation outcomes; and (4) Conduct a cost evaluation to assess the cost effectiveness of HOPE. The RCT will involve identifying in each of four sites a pool of HOPE-eligible probationers who will be randomly assigned to HOPE or to probation as usual (PAU). The evaluation will randomly assign approximately 400 eligible probationers to HOPE or PAU in each of the four sites for a total sample size of 1,600 (800 HOPE and 800 PAU). Criteria identifying the HOPE-eligible target population and procedures to identify that population in a timely fashion randomly assigning HOPE-eligible Probationers to HOPE or PAU have been identified. Random assignment will be accomplished using evaluation-provided forms that include study identification numbers and the random assignment that is covered by a scratch-off label. The assignment will be revealed only after the individual has been provided the opportunity to participate in the evaluation and, with consent, completed the baseline interview. The process evaluation/fidelity assessment component will document the extent to which each program conforms to the HOPE model; document the barriers, challenges, facilitators, and lessons learned during implementation to fill gaps in the knowledge base as to what is required to set up a HOPE program; and provide evidence as to the generalizability and sustainability of HOPE programs. This component will also document the PAU control conditions in each site and will assess implementation fidelity of evidence-based drug treatment programs. Implementation and process measures will be collected through stakeholder interviews; observation of initial warning hearings and court appearances; and review of court, probation, and HOPE project records. The process evaluation will also document the PAU practices to identify intervention differences among the control groups and to provide an opportunity to measure changes in practices that could signal contamination of the control arm. Fidelity assessments of drug treatment programs will be conducted using the Correctional Program Checklist. The outcome study will assess whether HOPE participation improves appointment compliance, drug test results, rearrest rates, revocation rates, jail days served, and prison days sentenced. In addition, the evaluation will determine whether HOPE participation changes potential mediators including criminal thinking/attitudes, perceptions of control and justice system fairness and legitimacy, dynamic recidivism risk factors, and employment and housing stability. For the outcome study, administrative data will provide information on appointment compliance, drug test results, re-arrests, violations, revocations, and jail and prison days for all HOPE and PAU evaluation participants. Interview data will be collected from evaluation participants at evaluation enrollment and 6 months post-enrollment on measures that will facilitate understanding of the nature of individual change associated with HOPE participation. All HOPE-eligible Probationers who consent to study participation will complete an audio computer assisted self interview (ACASI) at baseline and 6 months post baseline; a random sample of those completing ACASI baseline interviews will be asked to participate in a twice-weekly series of mini-interviews (telephone-ACASI or T-ACASI). Non-incarcerated individuals are being offered $20 equivalent to complete the ACASI interview. Random drug tests on a subsample of HOPE and PAU evaluation participants will be conducted in conjunction with the 6-month post-enrollment interviews to provide a common measure of current drug use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPE | Experimental | Behavioral: HOPEParticipation in HOPE program |
| Probation as Usual | Active comparator | Behavioral: Probation as UsualParticipation in probation as usual |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult probationers assessed as high risk for failure on probation (e.g., high likelihood of new arrest, failure to comply with conditions) who live within the geographic boundaries of the study site with at least 11.5 months remaining on their probation sentence
Key exclusion criteria (4 listed)
- Juveniles
- live outside geographic boundaries
- assigned to specialized probation caseloads (e.g., sex offender, DUI, mental health)
- non-English speaking in some sites
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 |
|---|---|---|
| HOPEHOPE Court Judge provides warning hearing; random drug testing; violation hearing and jail/other sanctions for failed drug test or failure to comply with other probation conditions. | Behavioural | HOPE |
| Probation as UsualProbation officer supervises following standard protocols. | Behavioural | Probation as Usual |
Primary outcome
Illegal drug use
Time frame: 6 months
Multiple measures to include percent positive for (1) marijuana, (2) cocaine, (3) heroin, (4) methamphetamine, and (5) any illegal drug on an oral swab drug test administered in conjunction with the 6 month follow-up interview (subjects in the community, i.e. not jailed or institutionalized, only).
Rearrest
Time frame: 6 Months
Multiple measures to include (1) percent arrested within 6 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 6 months of baseline; and (5) percent arrested for (a) violent, and (b) property
Rearrest
Time frame: 12 months
Multiple measures to include (1) percent arrested within 12 months of baseline; (2) time to first (and subsequent) arrests following baseline; (3) number of arrests following baseline (variable follow-up period depending upon baseline date); (4) number of arrests within 12 months of baseline; and (5) percent arrested for (a) violent, (b) property, and (c) drug offenses within 12 months of baseline.
Probation Appointment Compliance
Time frame: 6 months
Number of missed appointments following baseline.
Probation Appointment Compliance
Time frame: 12 months
Number of missed appointments following baseline.
6 secondary outcomes
Probation revocation
Time frame: 6 months
jail days served
Time frame: 6 months
Probation Revocation
Time frame: 12 Months
Jail Days Served
Time frame: 12 months
Prison Days Sentenced
Time frame: 6 months
Prison Days Sentenced
Time frame: 12 months
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 15 Dec 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.
Pamela K Lattimore, PhD principal investigator
RTI International
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE and Probation as Usual in people with Substance Use and Criminal Recidivism, run by RTI International at 4 sites 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 1 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 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Illegal drug use (time frame: 6 months). The study lists 5 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 15 Dec 2017.