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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01668303
Other study ID # R01DA017478
Secondary ID
Status Completed
Phase N/A
First received August 6, 2012
Last updated August 14, 2012
Start date June 2004
Est. completion date November 2009

Study information

Verified date August 2012
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 18 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Miami Juvenile Drug Court-MDFT
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.
Miami Juvenile Drug Court -TAU
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.

Locations

Country Name City State
United States Here's Help Inc. Miami Florida
United States Jackson Memorial Hospital Miami Florida
United States Juvenile Drug Court Miami Florida
United States University of Miami Miller School of Medicine Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Graduation from juvenile drug court Status of drug court graduation (graduated from drug court or did not graduate from drug court) Collected once at 12 months from intake/baseline. No
Primary Change in substance use Personal Experiences with Chemicals Inventory Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline No
Primary Change in delinquency 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 No
Primary Change in Mental health symptoms Youth and parent report: Child Behavior Checklist, Youth Self Report Baseline, 6, 12, 18 and 24 months after baseline No
Primary Change in Family functioning Youth and Parent Report: Family Environment Scales, Parental Stress Index, Behavior Affect Relationship Scales Baseline, 6, 14, 18, and 24 months after baseline No
Primary Length of treatment How many weeks of treatment received Collected once, at 12 months after baseline No
Primary Change in arrests Arrests will be extracted from juvenile justice records. 12 months before intake through 24 months after intake No
Primary Change in substance use Measured by the Timeline Follow Back Method Intake, 6, 12, 18, 24 months after intake No
Primary Change in substance use Urinanalysis to detect drugs Intake, 6, 12, 18 and 24 months after intake No
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