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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02023827
Other study ID # 5R44DA024900
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received December 18, 2013
Last updated September 27, 2016
Start date August 2013
Est. completion date October 2016

Study information

Verified date September 2016
Source Pro-Change Behavior Systems
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
RAYS Intervention
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.

Locations

Country Name City State
United States Iowa Juvenile Court Services, District 6 Cedar Rapids Iowa
United States Iowa Juvenile Court Services, District 7 Davenport Iowa
United States Iowa Juvenile Court Services, District 5 Des Moines Iowa
United States Iowa Juvenile Court Services, District 3 Sioux City Iowa
United States Iowa Juvenile Court Services, District 1 Waterloo Iowa

Sponsors (2)

Lead Sponsor Collaborator
Pro-Change Behavior Systems Iowa Juvenile Court Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2012 Nov 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Criminal recidivism based on self-report Assessed using the General Crime Scale (GCS) of the Global Appraisal of Individual Needs (GAIN) 12 months follow-up No
Primary Criminal recidivism based on official records Data will be provided by the Iowa Division of Criminal and Juvenile Justice Planning (CJJP) 12 months follow-up No
Primary 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 12 months follow-up No
Secondary Total count of criminal behavior based on self-report Assessed using the General Crime Scale (GCS) of the Global Appraisal of Individual Needs (GAIN) 12 months follow-up No
Secondary 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 12 months follow-up No
Secondary Emotional distress Assessed using the 5-item Internalizing Disorder Screener (IDScr) of the GAIN Short Screener 12 months follow-up No
Secondary 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 12 months follow-up No
Secondary 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 12 months follow-up No
Secondary 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 12 months follow-up No
Secondary Abstinence confirmed by urine drug testing Among youth who screened positive for substance abuse and/or dependence at baseline 12 months follow-up No
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