<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/NCT03249350</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA043578-01A1</org_study_id>
    <nct_id>NCT03249350</nct_id>
  </id_info>
  <brief_title>Enhancing Adolescent Substance Abuse Treatment</brief_title>
  <official_title>Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Social Learning Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Social Learning Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ultimate goal of this research is to facilitate rapid enhancement of youth substance&#xD;
      abuse treatments by determining the key mechanisms of change (i.e., what to target more&#xD;
      intensely to generate better outcomes). This work is critical because current outpatient&#xD;
      adolescent substance abuse treatments yield only small to medium effects that diminish once&#xD;
      treatment has ended. The proposed modern mediation study will address this serious public&#xD;
      health problem by experimentally evaluating the most critical factors causing change in&#xD;
      client outcomes during adolescent substance abuse treatment, directing the field to focus&#xD;
      treatment efforts on those factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescents with substance use disorders (SUD) are at high risk for significant deleterious&#xD;
      outcomes. Although several evidence-based practices for adolescent SUD exist, they yield only&#xD;
      small to medium effects that rapidly diminish (30-70% 6-month relapse rates). A promising&#xD;
      approach for determining how to enhance treatment is experimental mediation research. In&#xD;
      contrast to traditional correlational mediation approaches, experimental mediation permits&#xD;
      causal inference and is comprised of key steps: (A) Identify the putative mediating variable&#xD;
      for a treatment. (B) Enhance the treatment to target that mediator more intensely. (C)&#xD;
      Randomize youth to conditions, with the standard and enhanced versions of the treatment&#xD;
      targeting different &quot;levels&quot; of the same mediator. (D) Measure the mediator and outcomes&#xD;
      longitudinally. (E) Perform modern mediation analyses, coupled with analyses evaluating&#xD;
      causal inference, to determine if changes in the mediator are responsible for changes in&#xD;
      outcomes. This experimental test of mediation, focused on causality, facilitates rapid&#xD;
      improvement of treatments by specifying change mechanisms to target in order to improve&#xD;
      outcomes. These steps will be followed to elucidate the mediating processes in treatment for&#xD;
      adolescent SUD, with the ultimate goal of enhancing the strength and durability of SUD&#xD;
      treatments. The three most common putative mediating variables in adolescent SUD treatments&#xD;
      are parent management, behavioral regulation, and peer relations. For this study, parent&#xD;
      management was chosen as the target because it has evidenced the most potential for yielding&#xD;
      generalizable change in youth outcomes and also has been shown to indirectly improve youths'&#xD;
      behavioral regulation and peer relations. Of existing treatments for adolescent SUD,&#xD;
      family-based Contingency Management (CM) was chosen as the treatment to enhance because it is&#xD;
      highly amenable to an augmented focus on parenting, is less complex relative to other SUD&#xD;
      treatments, and has amassed considerable support in terms of efficacy and dissemination&#xD;
      potential. Thus, following experimental mediation steps, youth with SUD will be randomized to&#xD;
      receive either standard CM or enhanced CM (i.e., CM+) that targets parenting more intensely.&#xD;
      Repeated assessments for 12 months and longitudinal analyses will allow testing of mediating&#xD;
      processes. The investigators will examine whether parent management skills mediate the effect&#xD;
      of treatment on youth substance use and behavior problems (Aim 1). In addition, the&#xD;
      investigators will determine whether parent management skills mediate the effect of treatment&#xD;
      on youth behavioral regulation and deviant peer relations (Aim 2). Finally, the investigators&#xD;
      will test whether behavioral regulation and deviant peer relations mediate the effect of&#xD;
      parent management on youth substance use and behavior problems (Aim 3). Findings could have&#xD;
      broad impact across multiple adolescent SUD treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 23, 2018</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Youth Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, opiates, phencyclidine (PCP), cocaine, and alcohol metabolites (ethyl glucuronide, ethyl sulfate).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Youth Problem Behaviors (measured at 0, 2, 4, 6, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Youth problem behaviors as measured by the Child Behavior Checklist (parent-report) and the Youth Self Report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Parent Management (measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Parent management practices (monitoring/supervision, positive parenting, and consistent discipline) as measured by the Alabama Parenting Questionnaire (youth- and parent-report).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Parent Contingency Management (CM) Adherence (measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Parents' implementation of CM as measured by the CM Adherence Measure (youth- and parent-report).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Youth Substance Use and Problems (measured at 0, 2, 4, 6, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Frequency of substance use and substance-related problems as measured by the Global Appraisal of Individual Needs (youth-report).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Risk Taking (measured at 0, 2, 4, 6, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Behavioral regulation - risk taking as measured by the Behavioral Inhibition System (youth- and parent-report), the Behavioral Activation System (youth- and parent-report), and the Balloon Analogue Risk Task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Inhibitory Control (measured at 0, 2, 4, 6, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Behavioral regulation - inhibitory control as measured by the Early Adolescent Temperament Questionnaire-Revised (youth- and parent-report) and the Go/No Go Task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 12 months post-Baseline Peer Relations (measured at 0, 2, 4, 6, 9, &amp; 12 months).</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Peer relations (association with peers who engage in delinquent behaviors &amp; prosocial activities) as measured by the Peer Relations Questionnaire (youth- and parent-report).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">172</enrollment>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Standard Contingency Management (CM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive standard CM for adolescent substance abuse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Contingency Management (CM+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Contingency Management (CM)</intervention_name>
    <description>CM utilizes behavior modification &amp; cognitive behavioral strategies to target adolescent substance use. Protocol components are as follows: (a) The provider introduces CM to the youth and caregiver and engages them in the intervention; (b) The provider conducts Antecedent-Behavior-Consequence (ABC) assessments of the youth's AOD use with the youth and caregiver; (c) Based on the results of the ABC assessments, self-management planning and drug refusal skills training are implemented by the provider in collaboration with the youth and caregiver; (d) Concurrently, a point and level system contract is established with the family, which provides the youth with rewards/privileges for negative drug and alcohol tests and disincentives (e.g., extra chores) for positive tests. Until continued abstinence is achieved, components &quot;b&quot; through &quot;d&quot; are repeated; (e) The provider collaborates with the family to develop plans for sustaining long-term abstinence. Typical duration of CM is 12-16 weeks.</description>
    <arm_group_label>Standard Contingency Management (CM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Contingency Management (CM+)</intervention_name>
    <description>The CM+ protocol adds the behavioral assessment and teaching system from Parent Management Training Oregon (PMTO) to standard CM to enhance parent's skill acquisition more intensely. PMTO's behavioral assessment and teaching system uses three processes to bring about changes in parenting: daily parent reports on youth behavior, anti-coercive problem-solving, and structured learning and in vivo practice of new parenting techniques.</description>
    <arm_group_label>Enhanced Contingency Management (CM+)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 12 to 17 years&#xD;
&#xD;
          -  Presence of current substance use disorder&#xD;
&#xD;
          -  Availability of a parent/guardian willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Actively psychotic, suicidal, or homicidal&#xD;
&#xD;
          -  Pervasive developmental disorder or metal retardation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michael McCart, PhD</last_name>
    <phone>541-485-2711</phone>
    <email>MikeM@oslc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ashli Sheidow, PhD</last_name>
    <phone>541-485-2711</phone>
    <email>ashlis@oslc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Adolescent and Family Clinic, OSLC Developments, Inc.</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Marchini, MS</last_name>
      <phone>541-284-7560</phone>
      <email>juliem@oslc.org</email>
    </contact>
    <contact_backup>
      <last_name>Mike McCart, PhD</last_name>
      <phone>541-284-7560</phone>
      <email>mikem@oslc.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>May 11, 2022</last_update_submitted>
  <last_update_submitted_qc>May 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Social Learning Center</investigator_affiliation>
    <investigator_full_name>Mike McCart</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Substance Use Disorders</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Treatment</keyword>
  <keyword>Mediation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03249350
org study id: R01DA043578-01A1
nct id: NCT03249350
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The ultimate goal of this research is to facilitate rapid enhancement of youth substance
      abuse treatments by determining the key mechanisms of change (i.e., what to target more
      intensely to generate better outcomes). This work is critical because current outpatient
      adolescent substance abuse treatments yield only small to medium effects that diminish once
      treatment has ended. The proposed modern mediation study will address this serious public
      health problem by experimentally evaluating the most critical factors causing change in
      client outcomes during adolescent substance abuse treatment, directing the field to focus
      treatment efforts on those factors.
Adolescents with substance use disorders (SUD) are at high risk for significant deleterious
      outcomes. Although several evidence-based practices for adolescent SUD exist, they yield only
      small to medium effects that rapidly diminish (30-70% 6-month relapse rates). A promising
      approach for determining how to enhance treatment is experimental mediation research. In
      contrast to traditional correlational mediation approaches, experimental mediation permits
      causal inference and is comprised of key steps: (A) Identify the putative mediating variable
      for a treatment. (B) Enhance the treatment to target that mediator more intensely. (C)
      Randomize youth to conditions, with the standard and enhanced versions of the treatment
      targeting different "levels" of the same mediator. (D) Measure the mediator and outcomes
      longitudinally. (E) Perform modern mediation analyses, coupled with analyses evaluating
      causal inference, to determine if changes in the mediator are responsible for changes in
      outcomes. This experimental test of mediation, focused on causality, facilitates rapid
      improvement of treatments by specifying change mechanisms to target in order to improve
      outcomes. These steps will be followed to elucidate the mediating processes in treatment for
      adolescent SUD, with the ultimate goal of enhancing the strength and durability of SUD
      treatments. The three most common putative mediating variables in adolescent SUD treatments
      are parent management, behavioral regulation, and peer relations. For this study, parent
      management was chosen as the target because it has evidenced the most potential for yielding
      generalizable change in youth outcomes and also has been shown to indirectly improve youths'
      behavioral regulation and peer relations. Of existing treatments for adolescent SUD,
      family-based Contingency Management (CM) was chosen as the treatment to enhance because it is
      highly amenable to an augmented focus on parenting, is less complex relative to other SUD
      treatments, and has amassed considerable support in terms of efficacy and dissemination
      potential. Thus, following experimental mediation steps, youth with SUD will be randomized to
      receive either standard CM or enhanced CM (i.e., CM+) that targets parenting more intensely.
      Repeated assessments for 12 months and longitudinal analyses will allow testing of mediating
      processes. The investigators will examine whether parent management skills mediate the effect
      of treatment on youth substance use and behavior problems (Aim 1). In addition, the
      investigators will determine whether parent management skills mediate the effect of treatment
      on youth behavioral regulation and deviant peer relations (Aim 2). Finally, the investigators
      will test whether behavioral regulation and deviant peer relations mediate the effect of
      parent management on youth substance use and behavior problems (Aim 3). Findings could have
      broad impact across multiple adolescent SUD treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes from Baseline scores compared to 12 months post-Baseline Youth Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 9, & 12 months).
time frame: Baseline to 12 months
description: The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, opiates, phencyclidine (PCP), cocaine, and alcohol metabolites (ethyl glucuronide, ethyl sulfate).
measure: Changes from Baseline scores compared to 12 months post-Baseline Youth Problem Behaviors (measured at 0, 2, 4, 6, 9, & 12 months).
time frame: Baseline to 12 months
description: Youth problem behaviors as measured by the Child Behavior Checklist (parent-report) and the Youth Self Report.
measure: Changes from Baseline scores compared to 12 months post-Baseline Parent Management (measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, & 12 months).
time frame: Baseline to 12 months
description: Parent management practices (monitoring/supervision, positive parenting, and consistent discipline) as measured by the Alabama Parenting Questionnaire (youth- and parent-report).
measure: Changes from Baseline scores compared to 12 months post-Baseline Parent Contingency Management (CM) Adherence (measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, & 12 months).
time frame: Baseline to 12 months
description: Parents' implementation of CM as measured by the CM Adherence Measure (youth- and parent-report).
measure: Changes from Baseline scores compared to 12 months post-Baseline Youth Substance Use and Problems (measured at 0, 2, 4, 6, 9, & 12 months).
time frame: Baseline to 12 months
description: Frequency of substance use and substance-related problems as measured by the Global Appraisal of Individual Needs (youth-report).
measure: Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Risk Taking (measured at 0, 2, 4, 6, 9, & 12 months).
time frame: Baseline to 12 months
description: Behavioral regulation - risk taking as measured by the Behavioral Inhibition System (youth- and parent-report), the Behavioral Activation System (youth- and parent-report), and the Balloon Analogue Risk Task.
measure: Changes from Baseline scores compared to 12 months post-Baseline Youth Behavioral Regulation - Inhibitory Control (measured at 0, 2, 4, 6, 9, & 12 months).
time frame: Baseline to 12 months
description: Behavioral regulation - inhibitory control as measured by the Early Adolescent Temperament Questionnaire-Revised (youth- and parent-report) and the Go/No Go Task.
measure: Changes from Baseline scores compared to 12 months post-Baseline Peer Relations (measured at 0, 2, 4, 6, 9, & 12 months).
time frame: Baseline to 12 months
description: Peer relations (association with peers who engage in delinquent behaviors & prosocial activities) as measured by the Peer Relations Questionnaire (youth- and parent-report).
arm group label: Standard Contingency Management (CM)
arm group type: Active Comparator
description: This group will receive standard CM for adolescent substance abuse.
arm group label: Enhanced Contingency Management (CM+)
arm group type: Experimental
description: This group will receive an enhanced CM protocol for adolescent substance abuse that targets parenting more intensely.
intervention type: Behavioral
intervention name: Standard Contingency Management (CM)
description: CM utilizes behavior modification & cognitive behavioral strategies to target adolescent substance use. Protocol components are as follows: (a) The provider introduces CM to the youth and caregiver and engages them in the intervention; (b) The provider conducts Antecedent-Behavior-Consequence (ABC) assessments of the youth's AOD use with the youth and caregiver; (c) Based on the results of the ABC assessments, self-management planning and drug refusal skills training are implemented by the provider in collaboration with the youth and caregiver; (d) Concurrently, a point and level system contract is established with the family, which provides the youth with rewards/privileges for negative drug and alcohol tests and disincentives (e.g., extra chores) for positive tests. Until continued abstinence is achieved, components "b" through "d" are repeated; (e) The provider collaborates with the family to develop plans for sustaining long-term abstinence. Typical duration of CM is 12-16 weeks.
arm group label: Standard Contingency Management (CM)
intervention type: Behavioral
intervention name: Enhanced Contingency Management (CM+)
description: The CM+ protocol adds the behavioral assessment and teaching system from Parent Management Training Oregon (PMTO) to standard CM to enhance parent's skill acquisition more intensely. PMTO's behavioral assessment and teaching system uses three processes to bring about changes in parenting: daily parent reports on youth behavior, anti-coercive problem-solving, and structured learning and in vivo practice of new parenting techniques.
arm group label: Enhanced Contingency Management (CM+)
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Michael McCart, PhD
phone: 541-485-2711
email: MikeM@oslc.org
last name: Ashli Sheidow, PhD
phone: 541-485-2711
email: ashlis@oslc.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Social Learning Center
investigator full name: Mike McCart
investigator title: Senior Research Scientist
mesh term: Substance-Related Disorders
sharing ipd: No