<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/NCT02191956</url>
  </required_header>
  <id_info>
    <org_study_id>13-0078</org_study_id>
    <secondary_id>R01MH100377</secondary_id>
    <nct_id>NCT02191956</nct_id>
  </id_info>
  <brief_title>Technology to Enhance Treatment for Early Conduct Problems in Low Income Families</brief_title>
  <acronym>TE-HNC</acronym>
  <official_title>Technology to Enhance Treatment for Early Conduct Problems in Low Income Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to the test the efficacy and cost effectiveness of new service delivery&#xD;
      methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent&#xD;
      Training (BPT), for early onset disruptive behavior disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Families will be randomized to one of two active treatment conditions, the standard BPT&#xD;
      program or the standard BPT program plus some new service delivery methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Engagement</measure>
    <time_frame>Participants will be followed for the duration of treatment, an expected average of 10 weeks</time_frame>
    <description>Engagement includes multiple dimensions of participation in the treatment process, including items assessing attendance at weekly sessions, participation in mid-week calls, and home practice of skills.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends</measure>
    <time_frame>Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months</time_frame>
    <description>Disruptive behavior includes multiple dimensions of behavior, including items assessing noncompliance, aggression, and oppositionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Cost</measure>
    <time_frame>Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks</time_frame>
    <description>Cost is a multidimensional measure that includes items assessing both start-up (e.g., technology development) and implementation (e.g., therapist time) costs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Disruptive Behavior Disorders</condition>
  <arm_group>
    <arm_group_label>Behavioral Parent Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral Parent Training - Enhanced</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard of Care Behavioral Parent Training plus new delivery methods</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Parent Training</intervention_name>
    <description>Weekly clinic session, mid-week call, home practice</description>
    <arm_group_label>Behavioral Parent Training</arm_group_label>
    <arm_group_label>Behavioral Parent Training - Enhanced</arm_group_label>
    <other_name>Parent Management Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child aged 3 to 7 years&#xD;
&#xD;
          -  has clinically significant disruptive behaviors&#xD;
&#xD;
          -  low-income family&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregiver has current mood, substance use, and/or psychotic disorder&#xD;
&#xD;
          -  Child has current pervasive developmental and/or psychotic disorder&#xD;
&#xD;
          -  Family has current allegation and/or past substantiation with child protective&#xD;
             services&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah J Jones, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Department of Psychology</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Disruptive behavior disorders</keyword>
  <keyword>Early Onset</keyword>
  <keyword>Young Children</keyword>
  <keyword>Parenting</keyword>
  <keyword>Behavioral Parent Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
    <mesh_term>Attention Deficit and Disruptive Behavior 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/NCT02191956
org study id: 13-0078
secondary id: R01MH100377
nct id: NCT02191956
lead sponsor: 
collaborator: 
has dmc: No
This study aims to the test the efficacy and cost effectiveness of new service delivery
      methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent
      Training (BPT), for early onset disruptive behavior disorders.
Families will be randomized to one of two active treatment conditions, the standard BPT
      program or the standard BPT program plus some new service delivery methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Engagement
time frame: Participants will be followed for the duration of treatment, an expected average of 10 weeks
description: Engagement includes multiple dimensions of participation in the treatment process, including items assessing attendance at weekly sessions, participation in mid-week calls, and home practice of skills.
measure: Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends
time frame: Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months
description: Disruptive behavior includes multiple dimensions of behavior, including items assessing noncompliance, aggression, and oppositionality.
measure: Treatment Cost
time frame: Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks
description: Cost is a multidimensional measure that includes items assessing both start-up (e.g., technology development) and implementation (e.g., therapist time) costs.
arm group label: Behavioral Parent Training
arm group type: Active Comparator
description: Standard of care intervention
arm group label: Behavioral Parent Training - Enhanced
arm group type: Experimental
description: Standard of Care Behavioral Parent Training plus new delivery methods
intervention type: Behavioral
intervention name: Behavioral Parent Training
description: Weekly clinic session, mid-week call, home practice
arm group label: Behavioral Parent Training
arm group label: Behavioral Parent Training - Enhanced
other name: Parent Management Training
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
last name: Deborah J Jones, Ph.D.
role: Principal Investigator
affiliation: UNC Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Attention Deficit and Disruptive Behavior Disorders