<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/NCT04430010</url>
  </required_header>
  <id_info>
    <org_study_id>HM20019081</org_study_id>
    <secondary_id>R01MH124439</secondary_id>
    <nct_id>NCT04430010</nct_id>
  </id_info>
  <brief_title>Multi-level Determinants of Implementation and Sustainment in the Education Sector</brief_title>
  <official_title>Multi-level Determinants of Implementation and Sustainment in the Education Sector</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</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>Virginia Commonwealth University</source>
  <oversight_info>
    <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 learn more about teachers' sustainment of use of core&#xD;
      components of BEST in CLASS in a follow-up study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to help understand how to successfully implement and sustain&#xD;
      evidence based programs (EBP) in the education sector. The study will look at how questions&#xD;
      such as what teacher, program, and school characteristics impact sustainment of the EBP BEST&#xD;
      in CLASS, what modifications to BEST in CLASS represent a sustained program, and how do&#xD;
      teacher, program, and school characteristics influence sustainment of BEST in CLASS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 13, 2021</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Program Adherence</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>Change in the degree to which the teacher adheres to the BEST in CLASS treatment during observations as measure by the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Adherence scale. The TIES-A is an 18 item scale of BEST in CLASS practices. Teachers are rated on the presence (use) of each practice on a scale from 1 (not at all) to 7 (extensively). Scores are summed giving a range of 18 to 126. Higher scores are associated with greater adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Program Competence</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>Change in the degree to which the teacher adheres to the BEST in CLASS treatment during observations as measure by the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Competence scale. The TIES-C is an 18 item scale of BEST in CLASS practices. For all practices observed (greated than 1 on the Adherence scale) teachers are rated on the competency of their use of the practice on a scale from 1 (not at all) to 7 (extensively). Scores are summed giving a range of 0 to 126. Higher scores are associated with greater competence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in student disruptive behavior problems</measure>
    <time_frame>Baseline to 9 months</time_frame>
    <description>Student disruptive behaviors will be measured by the Social Skills Improvement System (SSIS) total problems scale. Higher scores represent more problem behaviors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in student prosocial behavior</measure>
    <time_frame>Baseline to 9 months</time_frame>
    <description>Student prosocial behaviors will be measured by the Social Skills Improvement System (SSIS) social skills scale. Higher scores represent more prosocial behavior.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">588</enrollment>
  <condition>Evidence Based Programs in Schools</condition>
  <arm_group>
    <arm_group_label>Implementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teachers will implement the BEST in CLASS treatment in their classrooms</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BEST in CLASS</intervention_name>
    <description>BEST in CLASS is a Tier-2 evidence based program (EBP) that has demonstrated effectiveness at reducing children's Disruptive Behavior Problems (DBPs) and risk for Emotional and Behavioral Disorders (EBDs)</description>
    <arm_group_label>Implementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Teacher participants&#xD;
&#xD;
          -  teach in general education Kindergarten, 1st, 2nd, or 3rd grade&#xD;
&#xD;
          -  consent to participate&#xD;
&#xD;
          -  proficient in English&#xD;
&#xD;
          -  participated as a BEST in CLASS teacher who received coaching in the prior year&#xD;
&#xD;
        Family participants&#xD;
&#xD;
          -  proficient in English&#xD;
&#xD;
          -  have a school-age child or children&#xD;
&#xD;
          -  consent to participate&#xD;
&#xD;
        Children participants&#xD;
&#xD;
          -  enrolled in a general Kindergarten, 1st, 2nd or 3rd grade classroom&#xD;
&#xD;
          -  proficient in English&#xD;
&#xD;
          -  at elevated risk for EBD&#xD;
&#xD;
          -  demonstration of externalizing behaviors that interfere with participation in the&#xD;
             classroom (e.g., disruption, aggression) as indicated by teacher rating&#xD;
&#xD;
          -  parental/guardian consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Teacher participants&#xD;
&#xD;
          -  do not teach in general education Kindergarten, 1st, 2nd, or 3rd grades&#xD;
&#xD;
          -  were not part of the BEST in CLASS intervention condition in the year prior&#xD;
&#xD;
          -  do not consent to participate&#xD;
&#xD;
          -  do not speak fluent English&#xD;
&#xD;
          -  do not have at least one student that meets the inclusion criteria&#xD;
&#xD;
        Family participants&#xD;
&#xD;
          -  do not speak proficient English&#xD;
&#xD;
          -  do not provide consent&#xD;
&#xD;
          -  do not have elementary aged children will be excluded.&#xD;
&#xD;
        Children participants&#xD;
&#xD;
          -  caregivers do not provide permission for participation&#xD;
&#xD;
          -  caregiver(s) do not speak proficient English&#xD;
&#xD;
          -  are not proficient in English&#xD;
&#xD;
          -  do not screen in as demonstrating risk for EBD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryce D McLeod, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maureen Conroy, PhD</last_name>
      <phone>352-273-4382</phone>
      <email>mconroy@coe.ufl.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin Sutherland, PhD</last_name>
      <phone>804-827-2652</phone>
      <email>kssuther@vcu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04430010
org study id: HM20019081
secondary id: R01MH124439
nct id: NCT04430010
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn more about teachers' sustainment of use of core
      components of BEST in CLASS in a follow-up study.
The goal of this study is to help understand how to successfully implement and sustain
      evidence based programs (EBP) in the education sector. The study will look at how questions
      such as what teacher, program, and school characteristics impact sustainment of the EBP BEST
      in CLASS, what modifications to BEST in CLASS represent a sustained program, and how do
      teacher, program, and school characteristics influence sustainment of BEST in CLASS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Program Adherence
time frame: baseline to 9 months
description: Change in the degree to which the teacher adheres to the BEST in CLASS treatment during observations as measure by the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Adherence scale. The TIES-A is an 18 item scale of BEST in CLASS practices. Teachers are rated on the presence (use) of each practice on a scale from 1 (not at all) to 7 (extensively). Scores are summed giving a range of 18 to 126. Higher scores are associated with greater adherence.
measure: Change in Program Competence
time frame: baseline to 9 months
description: Change in the degree to which the teacher adheres to the BEST in CLASS treatment during observations as measure by the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Competence scale. The TIES-C is an 18 item scale of BEST in CLASS practices. For all practices observed (greated than 1 on the Adherence scale) teachers are rated on the competency of their use of the practice on a scale from 1 (not at all) to 7 (extensively). Scores are summed giving a range of 0 to 126. Higher scores are associated with greater competence.
measure: Change in student disruptive behavior problems
time frame: Baseline to 9 months
description: Student disruptive behaviors will be measured by the Social Skills Improvement System (SSIS) total problems scale. Higher scores represent more problem behaviors.
measure: Change in student prosocial behavior
time frame: Baseline to 9 months
description: Student prosocial behaviors will be measured by the Social Skills Improvement System (SSIS) social skills scale. Higher scores represent more prosocial behavior.
arm group label: Implementation
arm group type: Experimental
description: Teachers will implement the BEST in CLASS treatment in their classrooms
intervention type: Behavioral
intervention name: BEST in CLASS
description: BEST in CLASS is a Tier-2 evidence based program (EBP) that has demonstrated effectiveness at reducing children's Disruptive Behavior Problems (DBPs) and risk for Emotional and Behavioral Disorders (EBDs)
arm group label: Implementation
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bryce D McLeod, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No