<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/NCT03303482</url>
  </required_header>
  <id_info>
    <org_study_id>UW17246</org_study_id>
    <nct_id>NCT03303482</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators</brief_title>
  <official_title>A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United Way of Greater Philadelphia and Southern New Jersey (UWGPSNJ)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lakeside Global Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The School District of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</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>
      Background. To increase school readiness, Pre-K programs for low-income children must be&#xD;
      responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018,&#xD;
      the School District of Philadelphia's (SDP) Office of Early Childhood Education will help&#xD;
      Pre-K teachers support children's social-emotional and behavioral health, which is essential&#xD;
      for early learning, by offering teachers a professional development course called Enhancing&#xD;
      Trauma Awareness (ETA).&#xD;
&#xD;
      Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2)&#xD;
      more trusting work relationships; and 3) better health.&#xD;
&#xD;
      Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve&#xD;
      exclusively low-income (≤300 % of poverty) children.&#xD;
&#xD;
      Intervention. A 12-week professional development course-Enhancing Trauma Awareness-will&#xD;
      delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and&#xD;
      each session lasting 2.5 hours.&#xD;
&#xD;
      Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or&#xD;
      assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or&#xD;
      spring 2018 (wait-list control groups).&#xD;
&#xD;
      Data collection and analysis. An external evaluation team (Temple University) will administer&#xD;
      a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter&#xD;
      2017 (after fall course), and spring 2018 (after spring course). Teacher-children&#xD;
      relationship quality will be the a priori primary outcome, and secondary outcomes will be&#xD;
      assessed across the domains of work functioning, trust, and health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</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>
    <intervention_model_description>The investigators will randomly assign consenting teachers by classroom (lead teacher and/or assistant teacher) to either the fall or spring course (intervention and waitlist control groups, respectively). The course will be taught to groups of 16 teachers, with four groups in the fall course (64 teachers) and four in the spring course (64 teachers). To determine the impacts of the training intervention on those assigned to the fall course (intervention groups), those assigned to the spring course (control groups) will serve as concurrent controls during the fall.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months</measure>
    <time_frame>The teacher-children relationship quality measurement will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
    <description>A modified version of the Student-Teacher Relationship Scale (STRS) conflict subscale will be used to allow each teacher to provide one global or aggregated assessment of her/his relationships with all the children in the classroom. The conflict subscale includes eight items to assess negative, insecure, and hostile aspects of relationships.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mindfulness (Cognitive and Affective Mindfulness Scale-Revised) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in empathy (Interpersonal Reactivity Index) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emotion regulation (Emotion Regulation Questionnaire) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in compassion satisfaction (Professional Quality of Life Scale) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in job satisfaction (adapted from Gallup Well-Being Work Index) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes about trauma-informed care (Attitudes Related to Trauma-Informed Care Scale) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in burnout (Maslach Burnout Inventory General) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in trust in relationships with parents, supervisors, and other staff members (adapted from Trust in Schools Instruments) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mentally and physically unhealthy days (CDC Health-Related Quality of Life Healthy Days Core Module) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality and duration of nighttime sleep (Pittsburgh Sleep Quality Index) at 3 months</measure>
    <time_frame>The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Burnout, Professional</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)</intervention_name>
    <description>The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks). The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed. The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Preschool classroom teacher who works in a center that is under the&#xD;
        auspice of the School District of Philadelphia and serves exclusively low-income (≤300 % of&#xD;
        poverty) children.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Whitaker, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>01940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Temple University</investigator_affiliation>
    <investigator_full_name>Robert Whitaker</investigator_full_name>
    <investigator_title>Professor of Epidemiology and Biostatistics and Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</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/NCT03303482
org study id: UW17246
nct id: NCT03303482
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background. To increase school readiness, Pre-K programs for low-income children must be
      responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018,
      the School District of Philadelphia's (SDP) Office of Early Childhood Education will help
      Pre-K teachers support children's social-emotional and behavioral health, which is essential
      for early learning, by offering teachers a professional development course called Enhancing
      Trauma Awareness (ETA).

      Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2)
      more trusting work relationships; and 3) better health.

      Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve
      exclusively low-income (≤300 % of poverty) children.

      Intervention. A 12-week professional development course-Enhancing Trauma Awareness-will
      delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and
      each session lasting 2.5 hours.

      Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or
      assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or
      spring 2018 (wait-list control groups).

      Data collection and analysis. An external evaluation team (Temple University) will administer
      a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter
      2017 (after fall course), and spring 2018 (after spring course). Teacher-children
      relationship quality will be the a priori primary outcome, and secondary outcomes will be
      assessed across the domains of work functioning, trust, and health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will randomly assign consenting teachers by classroom (lead teacher and/or assistant teacher) to either the fall or spring course (intervention and waitlist control groups, respectively). The course will be taught to groups of 16 teachers, with four groups in the fall course (64 teachers) and four in the spring course (64 teachers). To determine the impacts of the training intervention on those assigned to the fall course (intervention groups), those assigned to the spring course (control groups) will serve as concurrent controls during the fall.
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months
time frame: The teacher-children relationship quality measurement will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
description: A modified version of the Student-Teacher Relationship Scale (STRS) conflict subscale will be used to allow each teacher to provide one global or aggregated assessment of her/his relationships with all the children in the classroom. The conflict subscale includes eight items to assess negative, insecure, and hostile aspects of relationships.
measure: Change in mindfulness (Cognitive and Affective Mindfulness Scale-Revised) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in empathy (Interpersonal Reactivity Index) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in emotion regulation (Emotion Regulation Questionnaire) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in compassion satisfaction (Professional Quality of Life Scale) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in job satisfaction (adapted from Gallup Well-Being Work Index) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in attitudes about trauma-informed care (Attitudes Related to Trauma-Informed Care Scale) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in burnout (Maslach Burnout Inventory General) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in trust in relationships with parents, supervisors, and other staff members (adapted from Trust in Schools Instruments) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in mentally and physically unhealthy days (CDC Health-Related Quality of Life Healthy Days Core Module) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
measure: Change in quality and duration of nighttime sleep (Pittsburgh Sleep Quality Index) at 3 months
time frame: The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
arm group label: Intervention Group
arm group type: Experimental
arm group label: Waitlist Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)
description: The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks). The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed. The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Whitaker, MD, MPH
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Temple University
investigator full name: Robert Whitaker
investigator title: Professor of Epidemiology and Biostatistics and Pediatrics
mesh term: Burnout, Professional
sharing ipd: No