DelinquencyPhase 2NCT02023827
Computerized Stage-Matched Intervention for Juvenile Offenders
A Phase 2 study testing RAYS Intervention in people with Delinquency and Substance Abuse, run by Pro-Change Behavior Systems at 5 sites in United States.
Trial summary
Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders themselves. However, research assessing the efficacy of interventions for young offenders show, on average, only small effects on recidivism, substance abuse, and other behavioral outcomes. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Delinquency, Substance Abuse
- What is being tested?
- RAYS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2013to Oct 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Juvenile offenders:
- Score in the moderate- to high-risk range on the short-form Iowa Delinquency Assessment
- Age 13 to 17 at the time of recruitment
- Able to understand and read English
- Probation officers:
- Employed by Iowa Juvenile Court Services
- Work with moderate- to high-risk youth
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Iowa Juvenile Court Services, District 6
Cedar Rapids, Iowa, 52404
Iowa Juvenile Court Services, District 7
Davenport, Iowa, 52801
Iowa Juvenile Court Services, District 5
Des Moines, Iowa, 50310
Iowa Juvenile Court Services, District 3
Sioux City, Iowa, 51101
Iowa Juvenile Court Services, District 1
Waterloo, Iowa, 50704
About this study
Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders themselves. However, research assessing the efficacy of interventions for young offenders show, on average, only small effects on recidivism, substance abuse, and other behavioral outcomes. A major problem with existing interventions is that they tend to neglect individual differences in motivation and readiness to make positive changes. In earlier research, we used an empirically validated model of behavior change, the Transtheoretical Model (TTM, the "stage" model), and expert system technology to develop the Rise Above Your Situation program (RAYS), a prototype of a multimedia computerized tailored intervention designed as an adjunct to traditional juvenile justice programs. The intervention delivers assessments and individualized feedback matched to readiness to stay out of trouble with the law and quit alcohol and drugs. At the end each session the program also generates a helpgiver report that summarizes the youth's feedback and presents concrete, easy-to-implement strategies helpgivers can use to reinforce stage-matched concepts. In the current research, the goals are to complete development of the computerized tailored intervention; develop training and other support materials for helpgivers; and assess the efficacy of the intervention package in a randomized clinical trial involving 700 medium- to high-risk court-involved juveniles aged 13-17 recruited by 54 probation officers randomly assigned to treatment or standard care. Primary outcomes will be criminal recidivism and substance abuse abstinence at 6 and 12 months follow-up.
Read the detailed description
Fifty-four probation officers employed by the Iowa's Juvenile Court Services agreed to participate in the study and to be randomly assigned to treatment or standard care. A Multiattribute Utility Measurement Approach (Graham, Flay, Johnson, Hansen, \& Collins, 1984) was used to ensure that probation officers assigned to the two conditions were approximately equivalent on level of education, years of experience working with juvenile offenders, number of hours of training on the TTM, and confidence using the TTM in their work.
Probation officers were responsible for recruiting moderate- and high-risk youth on probation, and delivering baseline assessment sessions and intervention sessions. However, local project site coordinators were available to provide assistance, as needed.
Computerized follow-up assessments and urine drug testing at 6 and 12 months follow-up are being administered by "trackers" at a time and place that is convenient for the youth. Study protocols include best practices (Scott, 2004) for maximizing retention at follow-up in research involving high-risk populations.
- Conditions
- Delinquency, Substance Abuse
- Being tested
- RAYS Intervention
- Keywords
- Transtheoretical Model, Stages of change, Computer-tailored intervention, Delinquency, Substance abuse, Juvenile offender, Juvenile justice, Rise Above Your Situation (RAYS) program
- 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.
RAYS InterventionBehavioural
The Rise Above Your Situation program (RAYS) is a multimedia computer-tailored intervention that relies on the Transtheoretical Model of Behavior Change (TTM) and expert system technology to deliver assessments, feedback, printed reports, and helpgiver reports with intervention ideas. Helpgivers (probation officers in this case) use the reports to guide 1/2 hour follow-up discussions to reinforce intervention ideas and provide support.
| Study group | Role | What they receive |
|---|---|---|
| RAYS intervention | Experimental | In addition to standard care, participants receive three monthly online RAYS sessions, each followed by a one-on-one discussion with the probation officer Receives: Behavioral: RAYS Intervention |
| Standard care | No intervention | Participants receive standard care from the probation officer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Criminal recidivism based on self-report
Assessed using the General Crime Scale (GCS) of the Global Appraisal of Individual Needs (GAIN)
Measured: 12 months follow-up
Criminal recidivism based on official records
Data will be provided by the Iowa Division of Criminal and Juvenile Justice Planning (CJJP)
Measured: 12 months follow-up
Substance use abstinence based on self-report
Among youth who screened positive for substance abuse and/or dependence at baseline, assessed using the Substance Frequency Scale (SFS) from the GAIN
Measured: 12 months follow-up
Secondary outcomes (7)
Total count of criminal behavior based on self-report
Assessed using the General Crime Scale (GCS) of the Global Appraisal of Individual Needs (GAIN)
Measured: 12 months follow-up
Stage of change for staying out of trouble with the law
Assessed using a self-report Transtheoretical Model of Behavior Change (TTM) stage of change measure developed by the PI
Measured: 12 months follow-up
Emotional distress
Assessed using the 5-item Internalizing Disorder Screener (IDScr) of the GAIN Short Screener
Measured: 12 months follow-up
Substance use frequency
Among youth who screened positive for substance abuse and/or dependence at baseline, assessed using the Substance Frequency Scale (SFS) from the GAIN
Measured: 12 months follow-up
Substance-related problems
Among youth who screened positive for substance abuse and/or dependence at baseline, assessed using the Substance Problem Scale (SPS) from the GAIN
Measured: 12 months follow-up
Stage of change for quitting alcohol and drugs
Among youth who screened positive for substance abuse and/or dependence at baseline, assessed using a self-report Transtheoretical Model of Behavior Change (TTM) stage of change measure developed by the PI
Measured: 12 months follow-up
Abstinence confirmed by urine drug testing
Among youth who screened positive for substance abuse and/or dependence at baseline
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DelinquencyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Iowa Juvenile Court Services
- Responsible party
- Principal investigator, Deborah Levesque, Pro-Change Behavior Systems
- Investigators
- Deborah A Levesque, Ph.D., Principal investigator, Pro-Change Behavior Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023827
- Sponsor's protocol ID
- 5R44DA024900
- Status last verified
- Sep 2016
- First submitted
- 18 Dec 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Levesque DA, Johnson JL, Welch CA, Prochaska JM, Fernandez AC. Computer-Tailored Intervention for Juvenile Offenders. J Soc Work Pract Addict. 2012 Jan 1;12(4):391-411. doi: 10.1080/1533256X.2012.728107. Epub 2012 Nov 8.
PubMed 23264754
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Stage-Matched Intervention for Juvenile Offenders
- ClinicalTrials.gov ID
- NCT02023827
- Acronym / sponsor ID
- 5R44DA024900
- Conditions
- Delinquency, Substance Abuse
- Keywords
- Transtheoretical Model, Stages of change, Computer-tailored intervention, Delinquency, Substance abuse, Juvenile offender, Juvenile justice, Rise Above Your Situation (RAYS) program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Collaborators
- Iowa Juvenile Court Services
- Study start
- Aug 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 30 Dec 2013 (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.
Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders themselves. However, research assessing the efficacy of interventions for young offenders show, on average, only small effects on recidivism, substance abuse, and other behavioral outcomes. A major problem with existing interventions is that they tend to neglect individual differences in motivation and readiness to make positive changes. In earlier research, we used an empirically validated model of behavior change, the Transtheoretical Model (TTM, the "stage" model), and expert system technology to develop the Rise Above Your Situation program (RAYS), a prototype of a multimedia computerized tailored intervention designed as an adjunct to traditional juvenile justice programs. The intervention delivers assessments and individualized feedback matched to readiness to stay out of trouble with the law and quit alcohol and drugs. At the end each session the program also generates a helpgiver report that summarizes the youth's feedback and presents concrete, easy-to-implement strategies helpgivers can use to reinforce stage-matched concepts. In the current research, the goals are to complete development of the computerized tailored intervention; develop training and other support materials for helpgivers; and assess the efficacy of the intervention package in a randomized clinical trial involving 700 medium- to high-risk court-involved juveniles aged 13-17 recruited by 54 probation officers randomly assigned to treatment or standard care. Primary outcomes will be criminal recidivism and substance abuse abstinence at 6 and 12 months follow-up.
Detailed description
Fifty-four probation officers employed by the Iowa's Juvenile Court Services agreed to participate in the study and to be randomly assigned to treatment or standard care. A Multiattribute Utility Measurement Approach (Graham, Flay, Johnson, Hansen, \& Collins, 1984) was used to ensure that probation officers assigned to the two conditions were approximately equivalent on level of education, years of experience working with juvenile offenders, number of hours of training on the TTM, and confidence using the TTM in their work.
Probation officers were responsible for recruiting moderate- and high-risk youth on probation, and delivering baseline assessment sessions and intervention sessions. However, local project site coordinators were available to provide assistance, as needed.
Computerized follow-up assessments and urine drug testing at 6 and 12 months follow-up are being administered by "trackers" at a time and place that is convenient for the youth. Study protocols include best practices (Scott, 2004) for maximizing retention at follow-up in research involving high-risk populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAYS intervention | Experimental | Behavioral: RAYS InterventionIn addition to standard care, participants receive three monthly online RAYS sessions, each followed by a one-on-one discussion with the probation officer |
| Standard care | No intervention | –Participants receive standard care from the probation officer |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Score in the moderate- to high-risk range on the short-form Iowa Delinquency Assessment
- Age 13 to 17 at the time of recruitment
- Able to understand and read English
- Employed by Iowa Juvenile Court Services
- Work with moderate- to high-risk youth
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RAYS InterventionThe Rise Above Your Situation program (RAYS) is a multimedia computer-tailored intervention that relies on the Transtheoretical Model of Behavior Change (TTM) and expert system technology to deliver assessments, feedback, printed reports, and helpgiver reports with intervention ideas. Helpgivers (probation officers in this case) use the reports to guide 1/2 hour follow-up discussions to reinforce intervention ideas and provide support. | Behavioural | RAYS intervention |
Primary outcome
Criminal recidivism based on self-report
Time frame: 12 months follow-up
Assessed using the General Crime Scale (GCS) of the Global Appraisal of Individual Needs (GAIN)
Criminal recidivism based on official records
Time frame: 12 months follow-up
Data will be provided by the Iowa Division of Criminal and Juvenile Justice Planning (CJJP)
Substance use abstinence based on self-report
Time frame: 12 months follow-up
Among youth who screened positive for substance abuse and/or dependence at baseline, assessed using the Substance Frequency Scale (SFS) from the GAIN
7 secondary outcomes
Total count of criminal behavior based on self-report
Time frame: 12 months follow-up
Stage of change for staying out of trouble with the law
Time frame: 12 months follow-up
Emotional distress
Time frame: 12 months follow-up
Substance use frequency
Time frame: 12 months follow-up
Substance-related problems
Time frame: 12 months follow-up
Stage of change for quitting alcohol and drugs
Time frame: 12 months follow-up
Abstinence confirmed by urine drug testing
Time frame: 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Background: PubMed 23264754Levesque DA, Johnson JL, Welch CA, Prochaska JM, Fernandez AC. Computer-Tailored Intervention for Juvenile Offenders. J Soc Work Pract Addict. 2012 Jan 1;12(4):391-411. doi: 10.1080/1533256X.2012.728107. Epub 2012 Nov 8.
- Individual participant dataSharing planned: No
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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.
Deborah A Levesque, Ph.D. principal investigator
Pro-Change Behavior Systems, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAYS Intervention in people with Delinquency and Substance Abuse, run by Pro-Change Behavior Systems at 5 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 7 inclusion and 0 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
Criminal recidivism based on self-report (time frame: 12 months follow-up). The study lists 3 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 NCT02023827, which also lists 1 linked publication.
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 28 Sep 2016.