We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Increasing Caregiver Engagement in Juvenile Drug Courts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051997
Recruitment Status : Active, not recruiting
First Posted : February 14, 2017
Last Update Posted : July 26, 2022
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Wayne State University
Alliant International University
Baylor University
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date July 26, 2022
Actual Study Start Date  ICMJE October 13, 2017
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Changes from baseline to 18 months post-baseline in Youth Urine Drug Screens (measured at 0, 3, 5, 6, 9, 12, and 18 months). [ Time Frame: Baseline to 18 months ]
    Number of positive drug screens from toxicology testing with youth for tetrahydrocannabinol (THC), amphetamines, methamphetamines, opiates, cocaine, benzodiazepines, MDMA, and oxycodone.
  • Changes from baseline to 18 months post-baseline in Youth Substance Use Frequency and Problems (measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 months). [ Time Frame: Baseline to 18 months ]
    Frequency of substance use and substance-related problems self-reported by youth on the Global Appraisal of Individual Needs.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Changes from baseline to 18 months post-baseline in Youth Arrests, Charges, and Convictions. [ Time Frame: Baseline to 18 months ]
    Number of youth arrests, charges, and convictions measured via official arrest records.
  • Changes from baseline to 18 months post-baseline in Youth Delinquent Behaviors (measured at 0, 3, 5, 6, 9, 12, and 18 months). [ Time Frame: Baseline to 18 months ]
    Frequency of delinquent behaviors self-reported by youth using the Self-Report Delinquency Scale.
  • Changes from Baseline to 18 months post-baseline in caregiver reports on Youth Internalizing Symptoms and Externalizing Behaviors (measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 months). [ Time Frame: Baseline to 18 months ]
    Frequency of youth's internalizing symptoms and externalizing behaviors measured with the Child Behavior Checklist (caregiver report).
  • Changes from Baseline to 18 months post-baseline in youth reports on Youth Internalizing Symptoms and Externalizing Behaviors (measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 months). [ Time Frame: Baseline to 18 months ]
    Frequency of youth's internalizing symptoms and externalizing behaviors measured with the Brief Problem Checklist (youth report).
  • Changes from baseline to post-treatment in Caregiver Substance Use Problems. [ Time Frame: Baseline through treatment completion, an average of 4 months ]
    Frequency and severity of substance use problems self-reported by caregivers on the Addiction Severity Index.
  • Changes from baseline to post-treatment in Caregiver Depressive Symptoms. [ Time Frame: Baseline through treatment completion, an average of 4 months ]
    Frequency and severity of depressive symptoms self-reported by caregivers on the Beck Depression Inventory.
  • Changes from baseline to post-treatment in Therapist-Family Working Alliance (measured at 1, 2, 3, and 4 months, as well as post-treatment). [ Time Frame: Baseline through treatment completion, an average of 4 months ]
    Levels of alliance during treatment reported by therapists, caregivers, and youth on the Working Alliance Inventory.
  • Changes from baseline to post-treatment in Caregiver Treatment Attendance and Activity Completion (measured at 1, 2, 3, and 4 months, as well as post-treatment). [ Time Frame: Baseline through treatment completion, an average of 4 months ]
    Frequency of caregiver attendance at their youth's substance use treatment sessions and completion of therapeutic activities reported by therapists on the Session Tracking Sheet.
  • Changes from baseline to the end of JDC involvement in Caregiver Attendance at JDC Sessions. [ Time Frame: Baseline through the end of JDC involvement, an average of 12 months ]
    Frequency of caregiver attendance at their youth's JDC sessions reported by JDC personnel on the JDC Attendance Form.
  • Rates of Treatment Completion. [ Time Frame: Up to 4 months on average ]
    Rates of youth treatment completion reported by therapists using the Treatment Termination Form.
  • Levels of Satisfaction with Treatment and JDC. [ Time Frame: Up to 4 months on average ]
    Levels of satisfaction with substance use treatment and JDC reported by caregivers and youth on the Client Satisfaction Questionnaire.
  • Changes from baseline to post-treatment in Caregiver Perceptions of Incentive Programs. [ Time Frame: Baseline through treatment completion, an average of 4 months ]
    Ratings by caregivers on perceptions of incentive-based interventions as measured by the Provider Survey of Incentives.
  • Changes from baseline to 36 months post-baseline in Therapist and JDC Personnel Perceptions of Incentive Programs (measured at 0, 12, 24, and 36 months). [ Time Frame: Baseline to 36 months ]
    Ratings by therapists and JDC personnel on perceptions of incentive-based interventions as measured by the Provider Survey of Incentives.
  • Reports at post-treatment on Youth and Caregiver Attitudes Toward Incentive Programs. [ Time Frame: Up to 4 months on average ]
    Youth and caregiver attitudes toward incentive programs as measured during qualitative interviews.
  • Changes from baseline to 36 months post-baseline in Therapist and JDC Personnel Attitudes Toward Incentive Programs (measured at 0, 12, 24, and 36 months). [ Time Frame: Baseline to 36 months ]
    Therapist and JDC personnel attitudes toward incentive programs as measured during qualitative interviews.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Caregiver Engagement in Juvenile Drug Courts
Official Title  ICMJE Behavioral Incentives to Increase Caregiver Engagement in Juvenile Drug Courts
Brief Summary The purpose of this study is to test a prize-based contingency management intervention for increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and for achieving the ultimate outcomes of reduced substance use and delinquent behavior among drug court-involved youth.
Detailed Description Juvenile offenders with substance abuse problems represent a large and underserved population that is at high risk of deleterious outcomes and long-term costs for themselves, their families, communities, and society. Moreover, a high percentage of substance abusing adolescents continue to abuse substances and engage in criminal activity into adulthood. Although one juvenile justice intervention, Juvenile Drug Court (JDC), has emerged as a promising model for reducing drug use and delinquency among youth, its effectiveness is variable. Drug court outcomes may be compromised by the lack of caregiver engagement in JDC processes and adolescent drug treatment. Incorporating easily implemented evidence-based incentive programs in JDCs might improve their effectiveness in reducing youth drug use and re-offending. An extensive body of research supports the critical role that families play in the etiology, maintenance, and treatment of adolescent substance abuse. Although family-based interventions for adolescent substance abuse have been shown to be superior to other treatment modalities, parents must attend treatment and participate in meaningful ways for these superior outcomes to be realized. This randomized clinical trial will examine the efficacy of a prize-based contingency management intervention for increasing caregiver engagement (attendance and participation) in JDC and adolescent drug treatment. This caregiver contingency management intervention (CCM) will be compared with drug court treatment as usual (TAU). Increased caregiver participation is predicted to improve adolescent outcomes (decreased drug use and delinquent behavior). One hundred and eighty youth enrolled in JDC will be randomly assigned along with a parent/caregiver to TAU or CCM. Analyses will examine measures of caregiver engagement in JDC as well as youth substance use (urine drug screens) and delinquent activity. Results from this study will demonstrate the effectiveness of CCM procedures for increasing caregiver attendance and participation in JDC and adolescent drug treatment above and beyond drug court and usual care. If effective, the CCM approach may ultimately be used to enhance JDC outcomes, thereby reducing substance use and recidivism in juvenile offenders served by this promising juvenile justice intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Substance Abuse
Intervention  ICMJE
  • Behavioral: Caregiver Contingency Management + Usual Drug Court Treatment
    In addition to receiving JDC treatment as usual described below, caregiver participants will receive prize draws for engaging in activities consistent with their adolescents' successful completion of the JDC program during the time the youth is actively involved in JDC and substance abuse treatment. Specific activities that may be reinforced include: attendance at drug court hearings; accompanying the youth to probation meetings; participating in home visits; attendance at the youth's drug treatment sessions; attendance at mental health provider meetings; attending groups for parents of youth with substance abuse issues; and completing other verifiable treatment-related activities. All activities will meet the goals of (directly or indirectly) enhancing caregiver participation in the JDC and/or treatment process. Caregivers will receive escalating chances for tangible reinforcers each week for completing up to 3 of the activities agreed upon by the caregiver and the therapist.
  • Behavioral: Usual Drug Court Treatment
    Standard outpatient substance abuse treatment services that a young person would receive while participating in JDC.
Study Arms  ICMJE
  • Experimental: Caregiver Contingency Management + Usual Drug Court Treatment
    This group will receive a caregiver contingency management intervention plus the standard outpatient substance abuse treatment services provided at JDC.
    Intervention: Behavioral: Caregiver Contingency Management + Usual Drug Court Treatment
  • Active Comparator: Usual Drug Court Treatment
    This group will receive the standard outpatient substance abuse treatment services provided at JDC.
    Intervention: Behavioral: Usual Drug Court Treatment
Publications * Ledgerwood DM, Cunningham PB. Juvenile Drug Treatment Court. Pediatr Clin North Am. 2019 Dec;66(6):1193-1202. doi: 10.1016/j.pcl.2019.08.011. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 25, 2022)
195
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
374
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for youth:

  • Involved in juvenile drug court
  • Aged 13-17 years
  • Youth is willing to participate
  • At least one caregiver is willing to participate in the youth's treatment
  • Fluent in English or Spanish

Exclusion Criteria for youth:

  • Diagnosed with intellectual disability or autism spectrum disorder

Inclusion Criteria for caregivers:

  • Caregiver of youth involved in juvenile drug court
  • Caregiver is willing to participate
  • Fluent in English or Spanish

Exclusion Criteria for caregivers:

  • Diagnosed with intellectual disability or autism spectrum disorder

Inclusion Criteria for therapists:

  • Providing substance abuse treatment to a youth in juvenile drug court

Exclusion Criteria for therapists:

  • None

Inclusion Criteria for Juvenile Drug Court Personnel:

  • Personnel working in juvenile drug court

Exclusion Criteria for Juvenile Drug Court Personnel:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 89 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03051997
Other Study ID Numbers  ICMJE R01MD011322( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medical University of South Carolina
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Wayne State University
  • Alliant International University
  • Baylor University
Investigators  ICMJE
Principal Investigator: Phillippe Cunningham, Ph.D. Medical University of South Carolina
Principal Investigator: David Ledgerwood, Ph.D. Wayne State University
Study Director: Stacy Ryan, Ph.D. The University of Texas Health Science Center at San Antonio
PRS Account Medical University of South Carolina
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP