<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/NCT03015805</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA041434-01</org_study_id>
    <nct_id>NCT03015805</nct_id>
  </id_info>
  <brief_title>Teen Success Project</brief_title>
  <acronym>JPO-CM</acronym>
  <official_title>Improving Access to Substance Abuse Evidence-Based Practices for Youth in the Justice System: Strategies Used by JPOs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Social Learning Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>George Mason University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Social Learning Center</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to examine the effectiveness of Juvenile Probation Officers&#xD;
      (JPOs) delivering Contingency Management (CM) to teens on their caseload who have problems&#xD;
      with drug use. CM has already been shown to be effective at helping teens with drug problems&#xD;
      but CM has never been delivered by JPOs. This study will test how well it works to have JPOs&#xD;
      deliver CM during their regular meetings with teens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching purpose of this study is to increase justice-involved youths' access to an&#xD;
      evidence-based practice for substance abuse, specifically Contingency Management (CM). This&#xD;
      randomized controlled trial will examine the effectiveness of using juvenile probation&#xD;
      officers (JPOs) to deliver CM to youth (aged 12-17 years) on their caseloads. CM is an&#xD;
      evidence-based practice for substance abuse. The Investigators posit that JPOs are in an&#xD;
      ideal position to deliver an evidence-based practice such as CM to youth because of their&#xD;
      intensive involvement and frequent contact with the youth offenders under their supervision.&#xD;
      The study randomizes 36 JPOs to 2 conditions: CM versus control (usual JPO services), and&#xD;
      then randomizes 504 drug-abusing adolescent probationers across those 2 conditions. The&#xD;
      research team will work with JPOs employed by the Department of Youth Services (DYS) in&#xD;
      various counties in Oregon. JPOs will participate in focus groups and research interviews and&#xD;
      will submit monthly audio-tapes of sessions with participating youth. JPOs randomized to the&#xD;
      CM condition will receive training in how to deliver CM. As stated, participating youth will&#xD;
      also be randomized to CM or control and assigned to a JPO in the same condition. For those in&#xD;
      the CM group, the delivery of CM will be added to their regular meetings with their JPO.&#xD;
      Research data will be collected from families via audio-taped interviews and questionnaires&#xD;
      from youth and one caretaker. Urine samples for drug testing will also be collected from&#xD;
      youth. Lastly, arrest records will be collected on youth for the 18 months pre- and&#xD;
      post-entry into the study. The study involves 2 types of participants: youth (n=504) and&#xD;
      juvenile probation officers (n=36), for a total of 540 anticipated participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Actual">September 14, 2022</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 9 months post-Baseline Urine Drug Screens (measured at 0, 3, 6 and 9 months).</measure>
    <time_frame>Baseline to 9 months</time_frame>
    <description>The number of positive drug screens from toxicology testing for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, opiates, phencyclidine (PCP), cocaine, benzodiazepines and alcohol metabolites (Ethyl glucuronide, Ethyl sulfate ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from Baseline scores compared to 9 months post-Baseline Substance Use and Problems (measured at 0, 3, 6 and 9 months).</measure>
    <time_frame>Baseline to 9 months</time_frame>
    <description>Frequency of substance use and substance-related problems self-reported on the Global Appraisal of Individual Needs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in number and severity of criminal charges in official records in the 18 months pre-Baseline compared with 18 months post-Baseline.</measure>
    <time_frame>18 months pre-Baseline to 18 months post-Baseline.</time_frame>
    <description>Changes from 18 months pre-Baseline in offending, measured in the number and severity of offenses in official arrest records compared to 18 months post-Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 9 months post-Baseline Delinquent Behaviors (measured at 0, 3, 6 and 9 months).</measure>
    <time_frame>Baseline to 9 months.</time_frame>
    <description>Delinquent behaviors self-reported using the Self-Report Delinquency Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 9 months post-Baseline Sexual Risk Behaviors (measured at 0, 3, 6 and 9 months).</measure>
    <time_frame>Baseline to 9 months.</time_frame>
    <description>Sexual risk behaviors self-reported using the HIV Sexual Risk Behavior Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 9 months post-BaselineTreatment Usage (measured at 0, 3, 6 and 9 months).</measure>
    <time_frame>Baseline to 9 months.</time_frame>
    <description>The number of courses of in-patient and out-patient treatment obtained by youth for substance abuse as measured by the Structured Adolescent Interview (conducted with youth and caregiver together).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 9 months post-Baseline Internalizing and Externalizing Behaviors (measured at 0, 3, 6 and 9 months).</measure>
    <time_frame>Baseline to 9 months.</time_frame>
    <description>The frequency of youth's internalizing and externalizing behaviors as measured using the Brief Problem Checklist (self- and parent-report).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline scores compared to 31 months post-Baseline Contingency Management (CM) Adherence (measured monthly for 31 months).</measure>
    <time_frame>Baseline to 31 months.</time_frame>
    <description>Adherence to CM practices by juvenile probation officers as measured using the CM-Therapist Adherence Measure (CM-TAM) (Self-report version, Tape Coding version and Youth/Caregiver versions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline in Training Needs and Training Satisfaction scores compared to 31 months post-Baseline (measured at 0,16 and 31 months).</measure>
    <time_frame>Baseline to 31 months.</time_frame>
    <description>Scores in training needs and training satisfaction as measured by the Organizational Readiness for Change-Criminal Justice Version (completed by participating juvenile probation officers).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline in attitudes towards using rewards in substance abuse treatment compared to 31 months post-Baseline (measured at 0,16 and 31 months).</measure>
    <time_frame>Baseline to 31 months.</time_frame>
    <description>Ratings on attitudes towards using rewards in substance use treatment as measured by the Provider Survey of Incentives (completed by participating juvenile probation officers).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Baseline in attitudes towards Contingency Management (CM) compared to 31 months post-Baseline (measured at 0,16 and 31 months).</measure>
    <time_frame>Baseline to 31 months.</time_frame>
    <description>Ratings on attitudes towards Contingency Management as measured by qualitative ratings of audio-taped and transcribed focus groups (focus groups involve participating juvenile probation officers).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>Contingency Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive regular probation services but will also receive the Contingency Management program for substance abuse from their juvenile probation officer during regular meetings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probation as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive regular services that are usually provided by juvenile probation officers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Contingency Management</intervention_name>
    <description>Contingency Management (CM) utilizes behavior modification &amp; cognitive behavioral strategies to target adolescent alcohol or other drug (AOD) use. Protocol components are as follows: (a) The provider introduces CM to the family 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 caregiver; (d) Concurrently, a point and level system contract is filled in by the family, which provides 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>Contingency Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Probation as Usual</intervention_name>
    <description>Standard services that a young person would receive while under probation supervision in the state of Oregon.</description>
    <arm_group_label>Probation as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        There are 2 types of participants in this study: youth and juvenile probation officers.&#xD;
&#xD;
        Inclusion Criteria for youth:&#xD;
&#xD;
          -  Newly opened probation case (can have previous cases)&#xD;
&#xD;
          -  12-17 years old&#xD;
&#xD;
          -  Diagnostic and Statistical Manual-5 (DSM-5) substance use disorder&#xD;
&#xD;
        Exclusion Criteria for youth:&#xD;
&#xD;
          -  Pervasive developmental disorder&#xD;
&#xD;
          -  Active psychotic disorder&#xD;
&#xD;
          -  Severe/profound mental retardation&#xD;
&#xD;
        Inclusion Criteria for juvenile probation officers:&#xD;
&#xD;
          -  Employed as a juvenile probation officer with the Department of Youth Services in a&#xD;
             participating county in Oregon&#xD;
&#xD;
          -  Serving clients aged 12-17 years old with a substance abuse problem&#xD;
&#xD;
        Exclusion Criteria for juvenile probation officers:&#xD;
&#xD;
          -  Not employed as a juvenile probation officer with the Department of Youth Services in&#xD;
             a participating county in Oregon&#xD;
&#xD;
          -  Not serving clients aged 12-17 years old with a substance abuse problem&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mini-Cassia Juvenile Probation</name>
      <address>
        <city>Rupert</city>
        <state>Idaho</state>
        <zip>83350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twin Falls Juvenile Probation</name>
      <address>
        <city>Twin Falls</city>
        <state>Idaho</state>
        <zip>83301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washoe County Juvenile Probation</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Social Learning Center</investigator_affiliation>
    <investigator_full_name>Ashli Sheidow</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <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/NCT03015805
org study id: R01DA041434-01
nct id: NCT03015805
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effectiveness of Juvenile Probation Officers
      (JPOs) delivering Contingency Management (CM) to teens on their caseload who have problems
      with drug use. CM has already been shown to be effective at helping teens with drug problems
      but CM has never been delivered by JPOs. This study will test how well it works to have JPOs
      deliver CM during their regular meetings with teens.
The overarching purpose of this study is to increase justice-involved youths' access to an
      evidence-based practice for substance abuse, specifically Contingency Management (CM). This
      randomized controlled trial will examine the effectiveness of using juvenile probation
      officers (JPOs) to deliver CM to youth (aged 12-17 years) on their caseloads. CM is an
      evidence-based practice for substance abuse. The Investigators posit that JPOs are in an
      ideal position to deliver an evidence-based practice such as CM to youth because of their
      intensive involvement and frequent contact with the youth offenders under their supervision.
      The study randomizes 36 JPOs to 2 conditions: CM versus control (usual JPO services), and
      then randomizes 504 drug-abusing adolescent probationers across those 2 conditions. The
      research team will work with JPOs employed by the Department of Youth Services (DYS) in
      various counties in Oregon. JPOs will participate in focus groups and research interviews and
      will submit monthly audio-tapes of sessions with participating youth. JPOs randomized to the
      CM condition will receive training in how to deliver CM. As stated, participating youth will
      also be randomized to CM or control and assigned to a JPO in the same condition. For those in
      the CM group, the delivery of CM will be added to their regular meetings with their JPO.
      Research data will be collected from families via audio-taped interviews and questionnaires
      from youth and one caretaker. Urine samples for drug testing will also be collected from
      youth. Lastly, arrest records will be collected on youth for the 18 months pre- and
      post-entry into the study. The study involves 2 types of participants: youth (n=504) and
      juvenile probation officers (n=36), for a total of 540 anticipated participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes from Baseline scores compared to 9 months post-Baseline Urine Drug Screens (measured at 0, 3, 6 and 9 months).
time frame: Baseline to 9 months
description: The number of positive drug screens from toxicology testing for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, opiates, phencyclidine (PCP), cocaine, benzodiazepines and alcohol metabolites (Ethyl glucuronide, Ethyl sulfate ).
measure: Changes from Baseline scores compared to 9 months post-Baseline Substance Use and Problems (measured at 0, 3, 6 and 9 months).
time frame: Baseline to 9 months
description: Frequency of substance use and substance-related problems self-reported on the Global Appraisal of Individual Needs.
measure: Changes in number and severity of criminal charges in official records in the 18 months pre-Baseline compared with 18 months post-Baseline.
time frame: 18 months pre-Baseline to 18 months post-Baseline.
description: Changes from 18 months pre-Baseline in offending, measured in the number and severity of offenses in official arrest records compared to 18 months post-Baseline.
measure: Changes from Baseline scores compared to 9 months post-Baseline Delinquent Behaviors (measured at 0, 3, 6 and 9 months).
time frame: Baseline to 9 months.
description: Delinquent behaviors self-reported using the Self-Report Delinquency Scale.
measure: Changes from Baseline scores compared to 9 months post-Baseline Sexual Risk Behaviors (measured at 0, 3, 6 and 9 months).
time frame: Baseline to 9 months.
description: Sexual risk behaviors self-reported using the HIV Sexual Risk Behavior Scale.
measure: Changes from Baseline scores compared to 9 months post-BaselineTreatment Usage (measured at 0, 3, 6 and 9 months).
time frame: Baseline to 9 months.
description: The number of courses of in-patient and out-patient treatment obtained by youth for substance abuse as measured by the Structured Adolescent Interview (conducted with youth and caregiver together).
measure: Changes from Baseline scores compared to 9 months post-Baseline Internalizing and Externalizing Behaviors (measured at 0, 3, 6 and 9 months).
time frame: Baseline to 9 months.
description: The frequency of youth's internalizing and externalizing behaviors as measured using the Brief Problem Checklist (self- and parent-report).
measure: Changes from Baseline scores compared to 31 months post-Baseline Contingency Management (CM) Adherence (measured monthly for 31 months).
time frame: Baseline to 31 months.
description: Adherence to CM practices by juvenile probation officers as measured using the CM-Therapist Adherence Measure (CM-TAM) (Self-report version, Tape Coding version and Youth/Caregiver versions).
measure: Changes from Baseline in Training Needs and Training Satisfaction scores compared to 31 months post-Baseline (measured at 0,16 and 31 months).
time frame: Baseline to 31 months.
description: Scores in training needs and training satisfaction as measured by the Organizational Readiness for Change-Criminal Justice Version (completed by participating juvenile probation officers).
measure: Changes from Baseline in attitudes towards using rewards in substance abuse treatment compared to 31 months post-Baseline (measured at 0,16 and 31 months).
time frame: Baseline to 31 months.
description: Ratings on attitudes towards using rewards in substance use treatment as measured by the Provider Survey of Incentives (completed by participating juvenile probation officers).
measure: Changes from Baseline in attitudes towards Contingency Management (CM) compared to 31 months post-Baseline (measured at 0,16 and 31 months).
time frame: Baseline to 31 months.
description: Ratings on attitudes towards Contingency Management as measured by qualitative ratings of audio-taped and transcribed focus groups (focus groups involve participating juvenile probation officers).
arm group label: Contingency Management
arm group type: Experimental
description: This group will receive regular probation services but will also receive the Contingency Management program for substance abuse from their juvenile probation officer during regular meetings.
arm group label: Probation as Usual
arm group type: Active Comparator
description: This group will receive regular services that are usually provided by juvenile probation officers.
intervention type: Behavioral
intervention name: Contingency Management
description: Contingency Management (CM) utilizes behavior modification & cognitive behavioral strategies to target adolescent alcohol or other drug (AOD) use. Protocol components are as follows: (a) The provider introduces CM to the family 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 caregiver; (d) Concurrently, a point and level system contract is filled in by the family, which provides 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: Contingency Management
intervention type: Behavioral
intervention name: Probation as Usual
description: Standard services that a young person would receive while under probation supervision in the state of Oregon.
arm group label: Probation as Usual
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Social Learning Center
investigator full name: Ashli Sheidow
investigator title: Senior Research Scientist
mesh term: Substance-Related Disorders
sharing ipd: No