<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/NCT03298724</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0872</org_study_id>
    <secondary_id>R324B160043</secondary_id>
    <secondary_id>A173000</secondary_id>
    <secondary_id>EDUC\EDUC PSYCHOLOGY</secondary_id>
    <nct_id>NCT03298724</nct_id>
  </id_info>
  <brief_title>Teachers and Parents as Partners During Middle School</brief_title>
  <official_title>Teachers and Parents as Partners During Middle School</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Education</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</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>
      There are two aims of this study (a) to examine the effect of Teachers and Parents as&#xD;
      Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers&#xD;
      and facilitators to implementing Teachers and Parents as Partners in middle school for&#xD;
      students with behavior concerns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Teachers and Parents as Partners will occur in a series of stages comprised of approximately&#xD;
      four structured meetings over approximately 8 weeks. A Teachers and Parents as Partners&#xD;
      consultant will meet together with a student's parent(s), teachers, other school personnel&#xD;
      (as appropriate), and the student (as appropriate). The Teachers and Parents as Partners team&#xD;
      will collaboratively address behavior problem solving objectives. Specific CBC objectives&#xD;
      include: identifying strengths and specific behaviors of concern, specifying alternative&#xD;
      prosocial behaviors, creating measurable behavior goals, co-constructing behavior&#xD;
      intervention/support plans to address the target concerns, creating sustainable conditions to&#xD;
      support plan implementation at home and school, and evaluating the plan to assess progress&#xD;
      toward goals.&#xD;
&#xD;
      Treatment integrity in multiple dimensions (e.g., engagement, dosage, adherence) will be&#xD;
      assessed at the two tiers of implementation (i.e., Teachers and Parents as Partners&#xD;
      procedural integrity and behavior support plan implementation) to determine the extent to&#xD;
      which procedures are implemented as designed.&#xD;
&#xD;
      During each structured meeting, Teachers and Parents as Partners consultants will inquire&#xD;
      with parents, teachers, other school personnel, and students about barriers and facilitators&#xD;
      to implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Actual">June 25, 2018</completion_date>
  <primary_completion_date type="Actual">June 25, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single case experimental design (multiple baseline across setting)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Direct Behavior Ratings (change over time)</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Parents and teachers provide ratings of child behavior</description>
  </primary_outcome>
  <other_outcome>
    <measure>Teacher report of student work completion (change over time)</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Teacher reported student work completion</description>
  </other_outcome>
  <other_outcome>
    <measure>Monitoring Scale (change over time)</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Parent Monitoring Knowledge of child activities</description>
  </other_outcome>
  <other_outcome>
    <measure>Problem solving competencies</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Parent and teacher reported problem solving competencies</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent-teacher relationship scale (change over time)</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Parents and teacher report on the parent-teacher relationship</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavior Intervention Rating Scale Revised</measure>
    <time_frame>up to 32 weeks</time_frame>
    <description>Parent, teacher, and student satisfaction with procedures</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Behavior Problem</condition>
  <arm_group>
    <arm_group_label>TAPP Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Teachers and Partners intervention will be provided</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Teachers and Parents as Partners</intervention_name>
    <description>A family-school partnership intervention to improve the home-school connection, parenting and teaching strategies, and child behavior outcomes.</description>
    <arm_group_label>TAPP Intervention</arm_group_label>
    <other_name>Conjoint Behavioral Consultation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students will be eligible if they have scores in the &quot;elevated&quot; or &quot;extremely&#xD;
             elevated&quot; risk categories on the parent and teacher version of the Behavior Assessment&#xD;
             Scale for Children (BASC) 3 Behavioral and Emotional Screening System (BESS). Parents,&#xD;
             and primary teachers and school staff associated with an eligible student will be&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who do not meet the inclusion criteria will be excluded from participation,&#xD;
             which includes their parent(s), teachers, and other school personnel. Students also&#xD;
             may not be eligible if they have mental health concerns that may not be appropriate&#xD;
             for Teachers and Parents as Partners or a research project (e.g., some internalizing&#xD;
             problems, students who pose an risk of harming themselves).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andy Garbacz</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 23, 2019</last_update_submitted>
  <last_update_submitted_qc>December 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03298724
org study id: 2017-0872
secondary id: R324B160043
secondary id: A173000
secondary id: EDUC\EDUC PSYCHOLOGY
nct id: NCT03298724
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are two aims of this study (a) to examine the effect of Teachers and Parents as
      Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers
      and facilitators to implementing Teachers and Parents as Partners in middle school for
      students with behavior concerns.
Teachers and Parents as Partners will occur in a series of stages comprised of approximately
      four structured meetings over approximately 8 weeks. A Teachers and Parents as Partners
      consultant will meet together with a student's parent(s), teachers, other school personnel
      (as appropriate), and the student (as appropriate). The Teachers and Parents as Partners team
      will collaboratively address behavior problem solving objectives. Specific CBC objectives
      include: identifying strengths and specific behaviors of concern, specifying alternative
      prosocial behaviors, creating measurable behavior goals, co-constructing behavior
      intervention/support plans to address the target concerns, creating sustainable conditions to
      support plan implementation at home and school, and evaluating the plan to assess progress
      toward goals.

      Treatment integrity in multiple dimensions (e.g., engagement, dosage, adherence) will be
      assessed at the two tiers of implementation (i.e., Teachers and Parents as Partners
      procedural integrity and behavior support plan implementation) to determine the extent to
      which procedures are implemented as designed.

      During each structured meeting, Teachers and Parents as Partners consultants will inquire
      with parents, teachers, other school personnel, and students about barriers and facilitators
      to implementation.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single case experimental design (multiple baseline across setting)
primary purpose: Treatment
masking: None (Open Label)
measure: Direct Behavior Ratings (change over time)
time frame: up to 32 weeks
description: Parents and teachers provide ratings of child behavior
measure: Teacher report of student work completion (change over time)
time frame: up to 32 weeks
description: Teacher reported student work completion
measure: Monitoring Scale (change over time)
time frame: up to 32 weeks
description: Parent Monitoring Knowledge of child activities
measure: Problem solving competencies
time frame: up to 32 weeks
description: Parent and teacher reported problem solving competencies
measure: Parent-teacher relationship scale (change over time)
time frame: up to 32 weeks
description: Parents and teacher report on the parent-teacher relationship
measure: Behavior Intervention Rating Scale Revised
time frame: up to 32 weeks
description: Parent, teacher, and student satisfaction with procedures
arm group label: TAPP Intervention
arm group type: Experimental
description: The Teachers and Partners intervention will be provided
intervention type: Behavioral
intervention name: Teachers and Parents as Partners
description: A family-school partnership intervention to improve the home-school connection, parenting and teaching strategies, and child behavior outcomes.
arm group label: TAPP Intervention
other name: Conjoint Behavioral Consultation
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andy Garbacz
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Problem Behavior
sharing ipd: Undecided