<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668303</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA017478</org_study_id>
    <nct_id>NCT01668303</nct_id>
  </id_info>
  <brief_title>Family-Based Juvenile Drug Court Services</brief_title>
  <acronym>JDC</acronym>
  <official_title>Family-Based Juvenile Drug Court Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the proposed study is to adapt and implement an efficacious adolescent&#xD;
      substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug&#xD;
      court service system. Additionally, the investigators will also examine the extent to which&#xD;
      MDFT can enhance the effectiveness of existing juvenile drug court services in terms of&#xD;
      decreasing drug use, delinquent behavior and arrests and improving school and vocational&#xD;
      outcomes. The study design is a fully randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many questions remain regarding optimal treatments for juvenile drug court. To address this&#xD;
      gap, the investigators will compare two treatments delivered in a drug court setting:&#xD;
      Multidimensional Family Therapy (MDFT) and adolescent group therapy (AGT). This 5-year study&#xD;
      will employ a fully randomized (2 conditions) by 5 assessment points (baseline, 6, 12, 18,&#xD;
      and 24 months following baseline), repeated measures intent-to-treat design with multiple&#xD;
      dependent variables. Adolescents who have been accepted into the Miami Juvenile Drug Court&#xD;
      (MJDC) will be randomized to receive one of two treatments: MDFT (n = 57) or AGT (n = 55).&#xD;
      The substance abuse treatments will be equivalent in terms of therapeutic dosage, and all&#xD;
      youth with receive the same drug court program with wtreatment received being the only&#xD;
      difference (family vs non-family treatment). In order to maximize the ecological validity of&#xD;
      the study, both treatments will be delivered by community-based drug abuse counselors. MDFT&#xD;
      will be delivered by providers at Jackson Memorial Hospital's Adolescent Substance Abuse&#xD;
      Program and AGT by providers at a separate facility, Here's Help.&#xD;
&#xD;
      Aim 1. Acceptability and Effectiveness. The study will address the comparative acceptability&#xD;
      and effectiveness of the two drug court programs in ways that are consistent with&#xD;
      recommendations from the juvenile drug court literature to consider multi-domain and multiple&#xD;
      perspectives of program goals and outcomes. First, effectiveness will be assessed in terms of&#xD;
      the differential rates at which youth in MDFT and AGT graduate from drug court, a primary&#xD;
      goal of the drug court program. Juvenile offending substance abusers and their families are&#xD;
      notoriously difficult to engage and retain in any type of treatment program, yet family-based&#xD;
      interventions have demonstrated impressive retention rates with these populations. Thus an&#xD;
      important aspect of the proposed effectiveness evaluation will be the extent to which the&#xD;
      MDFT intervention improves drug court program completion rates. Our second perspective on&#xD;
      effectiveness involves an examination of the rates of change in a number of critical domains,&#xD;
      including reductions in substance use, arrests, and delinquent behaviors, as well as&#xD;
      improvements in school/vocational performance over a 2-year period. With these&#xD;
      multidimensional outcome assessments the investigators will be able to explore different&#xD;
      dimensions and trajectories of recovery following drug court participation. This is&#xD;
      consistent with the aims of juvenile drug courts not only to reduce drug use and delinquency&#xD;
      but also to increase adolescents' prosocial skills and behaviors. The investigators are also&#xD;
      interested in examining multiple perspectives on the relative acceptability of MDFT to drug&#xD;
      court staff, teens, and families, as recommended by drug court researchers.&#xD;
&#xD;
      Aim 2. Drug Court Program Mechanisms. While the few existing studies of key drug court&#xD;
      factors have focused mainly on the structural and judicial aspects of drug court programs,&#xD;
      almost nothing is known about the treatment processes affecting drug court outcomes, or the&#xD;
      mechanisms of clinical and judicial component impact. Clearly, an important next step in this&#xD;
      specialty is to delineate the treatment processes and ingredients that maximize outcomes in&#xD;
      drug court, particularly in relation to the application of evidence-based therapy models&#xD;
      within drug court programs. Examination of change mechanisms is now recognized as an&#xD;
      essential feature of state-of-the-art drug abuse intervention research. Among those process&#xD;
      variables considered important in mediating drug treatment outcomes are the therapeutic&#xD;
      alliance that is formed between provider and client , and the extent to which a positive&#xD;
      collaborative relationship develops among all drug court team members, including the judge.&#xD;
      Research on family-based interventions supports the contention that family-based treatments&#xD;
      exert their effects through the reduction of family risk and the facilitation of protective&#xD;
      processes, and family functioning has been found to play a primary role in helping teens&#xD;
      achieve and maintain recovery after substance abuse treatment. In sum, given that the quest&#xD;
      to improve drug court program development, implementation, and outcomes rests in large part&#xD;
      on the clarification of the programs' mechanisms of action, drug court researchers have&#xD;
      turned their attention to analyses linking within-program processes to outcomes. The proposed&#xD;
      study will do likewise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2004</start_date>
  <completion_date type="Actual">November 2009</completion_date>
  <primary_completion_date type="Actual">November 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Graduation from juvenile drug court</measure>
    <time_frame>Collected once at 12 months from intake/baseline.</time_frame>
    <description>Status of drug court graduation (graduated from drug court or did not graduate from drug court)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in substance use</measure>
    <time_frame>Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline</time_frame>
    <description>Personal Experiences with Chemicals Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in delinquency</measure>
    <time_frame>Baseline, and then at 6, 12, 18, and 24 months after baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mental health symptoms</measure>
    <time_frame>Baseline, 6, 12, 18 and 24 months after baseline</time_frame>
    <description>Youth and parent report: Child Behavior Checklist, Youth Self Report</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Family functioning</measure>
    <time_frame>Baseline, 6, 14, 18, and 24 months after baseline</time_frame>
    <description>Youth and Parent Report: Family Environment Scales, Parental Stress Index, Behavior Affect Relationship Scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of treatment</measure>
    <time_frame>Collected once, at 12 months after baseline</time_frame>
    <description>How many weeks of treatment received</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in arrests</measure>
    <time_frame>12 months before intake through 24 months after intake</time_frame>
    <description>Arrests will be extracted from juvenile justice records.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in substance use</measure>
    <time_frame>Intake, 6, 12, 18, 24 months after intake</time_frame>
    <description>Measured by the Timeline Follow Back Method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in substance use</measure>
    <time_frame>Intake, 6, 12, 18 and 24 months after intake</time_frame>
    <description>Urinanalysis to detect drugs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Substance Use</condition>
  <condition>Delinquency</condition>
  <arm_group>
    <arm_group_label>Miami Juvenile Drug Court-MDFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miami Juvenile Drug Court -TAU</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Treatment as Usual (TAU) condition is primarily a peer group-based and individual approach that uses cognitive-behavioral principles and interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Miami Juvenile Drug Court-MDFT</intervention_name>
    <description>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.</description>
    <arm_group_label>Miami Juvenile Drug Court-MDFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Miami Juvenile Drug Court -TAU</intervention_name>
    <description>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.</description>
    <arm_group_label>Miami Juvenile Drug Court -TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (a) Substance abuse or dependence disorder requiring outpatient treatment, and (b)after&#xD;
        consulting with his or her attorney, the youth and family voluntarily agrees to enter&#xD;
        juvenile drug court.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (a) Their current offense is the sale of drugs, a gun offense, a violent offense, or sexual&#xD;
        battery,(b) their current offense is likely to merit commitment to a secure or locked&#xD;
        juvenile justice facility or (c) they have severe mental illness or retardation according&#xD;
        to their intake MJDC evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gayle A. Dakof, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Here's Help Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juvenile Drug Court</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Gayle Dakof</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>juvenile drug court</keyword>
  <keyword>adolescents</keyword>
  <keyword>substance abuse</keyword>
  <keyword>delinquency</keyword>
  <keyword>family therapy</keyword>
  <keyword>multidimensional family therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668303
org study id: R01DA017478
nct id: NCT01668303
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Graduation from juvenile drug court
time frame: Collected once at 12 months from intake/baseline.
description: Status of drug court graduation (graduated from drug court or did not graduate from drug court)
measure: Change in substance use
time frame: Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline
description: Personal Experiences with Chemicals Inventory
measure: Change in delinquency
time frame: Baseline, and then at 6, 12, 18, and 24 months after baseline
description: 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.
measure: Change in Mental health symptoms
time frame: Baseline, 6, 12, 18 and 24 months after baseline
description: Youth and parent report: Child Behavior Checklist, Youth Self Report
measure: Change in Family functioning
time frame: Baseline, 6, 14, 18, and 24 months after baseline
description: Youth and Parent Report: Family Environment Scales, Parental Stress Index, Behavior Affect Relationship Scales
measure: Length of treatment
time frame: Collected once, at 12 months after baseline
description: How many weeks of treatment received
measure: Change in arrests
time frame: 12 months before intake through 24 months after intake
description: Arrests will be extracted from juvenile justice records.
measure: Change in substance use
time frame: Intake, 6, 12, 18, 24 months after intake
description: Measured by the Timeline Follow Back Method
measure: Change in substance use
time frame: Intake, 6, 12, 18 and 24 months after intake
description: Urinanalysis to detect drugs
arm group label: Miami Juvenile Drug Court-MDFT
arm group type: Experimental
description: 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.
arm group label: Miami Juvenile Drug Court -TAU
arm group type: Other
description: The Treatment as Usual (TAU) condition is primarily a peer group-based and individual approach that uses cognitive-behavioral principles and interventions.
intervention type: Behavioral
intervention name: Miami Juvenile Drug Court-MDFT
description: 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.
arm group label: Miami Juvenile Drug Court-MDFT
intervention type: Behavioral
intervention name: Miami Juvenile Drug Court -TAU
description: 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.
arm group label: Miami Juvenile Drug Court -TAU
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gayle A. Dakof, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Gayle Dakof
investigator title: Associate Professor
mesh term: Substance-Related Disorders