- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668303
Family-Based Juvenile Drug Court Services (JDC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many questions remain regarding optimal treatments for juvenile drug court. To address this gap, the investigators will compare two treatments delivered in a drug court setting: Multidimensional Family Therapy (MDFT) and adolescent group therapy (AGT). This 5-year study will employ a fully randomized (2 conditions) by 5 assessment points (baseline, 6, 12, 18, and 24 months following baseline), repeated measures intent-to-treat design with multiple dependent variables. Adolescents who have been accepted into the Miami Juvenile Drug Court (MJDC) will be randomized to receive one of two treatments: MDFT (n = 57) or AGT (n = 55). The substance abuse treatments will be equivalent in terms of therapeutic dosage, and all youth with receive the same drug court program with wtreatment received being the only difference (family vs non-family treatment). In order to maximize the ecological validity of the study, both treatments will be delivered by community-based drug abuse counselors. MDFT will be delivered by providers at Jackson Memorial Hospital's Adolescent Substance Abuse Program and AGT by providers at a separate facility, Here's Help.
Aim 1. Acceptability and Effectiveness. The study will address the comparative acceptability and effectiveness of the two drug court programs in ways that are consistent with recommendations from the juvenile drug court literature to consider multi-domain and multiple perspectives of program goals and outcomes. First, effectiveness will be assessed in terms of the differential rates at which youth in MDFT and AGT graduate from drug court, a primary goal of the drug court program. Juvenile offending substance abusers and their families are notoriously difficult to engage and retain in any type of treatment program, yet family-based interventions have demonstrated impressive retention rates with these populations. Thus an important aspect of the proposed effectiveness evaluation will be the extent to which the MDFT intervention improves drug court program completion rates. Our second perspective on effectiveness involves an examination of the rates of change in a number of critical domains, including reductions in substance use, arrests, and delinquent behaviors, as well as improvements in school/vocational performance over a 2-year period. With these multidimensional outcome assessments the investigators will be able to explore different dimensions and trajectories of recovery following drug court participation. This is consistent with the aims of juvenile drug courts not only to reduce drug use and delinquency but also to increase adolescents' prosocial skills and behaviors. The investigators are also interested in examining multiple perspectives on the relative acceptability of MDFT to drug court staff, teens, and families, as recommended by drug court researchers.
Aim 2. Drug Court Program Mechanisms. While the few existing studies of key drug court factors have focused mainly on the structural and judicial aspects of drug court programs, almost nothing is known about the treatment processes affecting drug court outcomes, or the mechanisms of clinical and judicial component impact. Clearly, an important next step in this specialty is to delineate the treatment processes and ingredients that maximize outcomes in drug court, particularly in relation to the application of evidence-based therapy models within drug court programs. Examination of change mechanisms is now recognized as an essential feature of state-of-the-art drug abuse intervention research. Among those process variables considered important in mediating drug treatment outcomes are the therapeutic alliance that is formed between provider and client , and the extent to which a positive collaborative relationship develops among all drug court team members, including the judge. Research on family-based interventions supports the contention that family-based treatments exert their effects through the reduction of family risk and the facilitation of protective processes, and family functioning has been found to play a primary role in helping teens achieve and maintain recovery after substance abuse treatment. In sum, given that the quest to improve drug court program development, implementation, and outcomes rests in large part on the clarification of the programs' mechanisms of action, drug court researchers have turned their attention to analyses linking within-program processes to outcomes. The proposed study will do likewise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine
-
Miami, Florida, United States, 33136
- Jackson Memorial Hospital
-
Miami, Florida, United States, 33054
- Here's Help Inc.
-
Miami, Florida, United States, 33142
- Juvenile Drug Court
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(a) Substance abuse or dependence disorder requiring outpatient treatment, and (b)after consulting with his or her attorney, the youth and family voluntarily agrees to enter juvenile drug court.
Exclusion Criteria:
(a) Their current offense is the sale of drugs, a gun offense, a violent offense, or sexual battery,(b) their current offense is likely to merit commitment to a secure or locked juvenile justice facility or (c) they have severe mental illness or retardation according to their intake MJDC evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Miami Juvenile Drug Court-MDFT
Multidimensional family therapy (MDFT) is primarily a family-based approach (Liddle, 2002)which conducts individual sessions with the teen and parent[s] but not peer-group sessions.
|
MDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
|
Other: Miami Juvenile Drug Court -TAU
The Treatment as Usual (TAU) condition is primarily a peer group-based and individual approach that uses cognitive-behavioral principles and interventions.
|
Each client is provided with a primary outpatient counselor who develops a treatment plan to address long-range goals.
Family members are included in an assessment and treatment planning session at the beginning of treatment, but no formal family therapy is provided.
Group therapy topics include self-esteem enhancement, decision-making skills, stress/anger management, communication skills, health education, teen pregnancy prevention, and occupational/career planning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graduation from juvenile drug court
Time Frame: Collected once at 12 months from intake/baseline.
|
Status of drug court graduation (graduated from drug court or did not graduate from drug court)
|
Collected once at 12 months from intake/baseline.
|
Change in substance use
Time Frame: Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline
|
Personal Experiences with Chemicals Inventory
|
Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline
|
Change in delinquency
Time Frame: Baseline, and then at 6, 12, 18, and 24 months after baseline
|
Self-report, parent report, and juvenile justice records: Self-report delinquency scale, Youth Self Report, Child Behavior Checklist; arrests and disposition from juvenile justice records.
|
Baseline, and then at 6, 12, 18, and 24 months after baseline
|
Change in Mental health symptoms
Time Frame: Baseline, 6, 12, 18 and 24 months after baseline
|
Youth and parent report: Child Behavior Checklist, Youth Self Report
|
Baseline, 6, 12, 18 and 24 months after baseline
|
Change in Family functioning
Time Frame: Baseline, 6, 14, 18, and 24 months after baseline
|
Youth and Parent Report: Family Environment Scales, Parental Stress Index, Behavior Affect Relationship Scales
|
Baseline, 6, 14, 18, and 24 months after baseline
|
Length of treatment
Time Frame: Collected once, at 12 months after baseline
|
How many weeks of treatment received
|
Collected once, at 12 months after baseline
|
Change in arrests
Time Frame: 12 months before intake through 24 months after intake
|
Arrests will be extracted from juvenile justice records.
|
12 months before intake through 24 months after intake
|
Change in substance use
Time Frame: Intake, 6, 12, 18, 24 months after intake
|
Measured by the Timeline Follow Back Method
|
Intake, 6, 12, 18, 24 months after intake
|
Change in substance use
Time Frame: Intake, 6, 12, 18 and 24 months after intake
|
Urinanalysis to detect drugs
|
Intake, 6, 12, 18 and 24 months after intake
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gayle A. Dakof, Ph.D., University of Miami
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA017478 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Substance Use
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Substance Use Disorders | Cannabis Use | Alcohol Use, UnspecifiedUnited States
-
Woebot HealthNational Institute on Drug Abuse (NIDA); Stanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use Disorder | Cocaine Use DisorderUnited States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingSubstance Use | Substance Use Disorders | Substance DependenceUnited States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Wake Forest University Health SciencesNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Opioid Use | Drug Use | Substance MisuseUnited States
-
Centre for Addiction and Mental HealthUniversity of Missouri, St. LouisCompletedSubstance Use Disorders | Alcohol Use DisorderCanada
-
Istanbul UniversityCompletedSubstance Use | Substance Use Disorders | Substance AbuseTurkey
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)CompletedPTSD | Alcohol Use Disorders | Substance Use DisordersUnited States
Clinical Trials on Miami Juvenile Drug Court-MDFT
-
Medical University of South CarolinaWayne State University; National Institute on Minority Health and Health Disparities... and other collaboratorsCompleted
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...RecruitingAdvanced/ Metastatic Solid TumorsChina
-
Ohio State UniversityChildren's Bureau - Administration for Children and Families; Pickaway County... and other collaboratorsCompletedChild Abuse | Substance Use | Substance Abuse | Neglect, ChildUnited States
-
GlaxoSmithKlineCompleted
-
National Cancer Institute (NCI)RecruitingLugano Classification Limited Stage Hodgkin Lymphoma AJCC v8United States, Puerto Rico, Canada