<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/NCT04440228</url>
  </required_header>
  <id_info>
    <org_study_id>834488</org_study_id>
    <nct_id>NCT04440228</nct_id>
  </id_info>
  <brief_title>TeamSTEPPS in School Mental Health</brief_title>
  <official_title>Adapting and Implementing TeamSTEPPS in School Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an&#xD;
      evidence-based approach for teams that can be adapted for school mental health. TeamSTEPPS&#xD;
      has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is&#xD;
      designed to build competencies in the areas of leadership, situation monitoring, mutual&#xD;
      support, and communication and has been associated with improvements in teamwork and&#xD;
      communication as well as patient outcomes, such as decreased seclusion in psychiatric&#xD;
      hospitals. This approach has yet to be extended as an implementation strategy in school or&#xD;
      community mental health teams. If an evidence-based team approach like TeamSTEPPS can be&#xD;
      successfully applied to school mental health teams, it could provide a cost-effective&#xD;
      strategy for improving student mental health services and bolstering existing EBP&#xD;
      implementation efforts, which to date generally have been insufficient in producing long-term&#xD;
      clinician behavior change. In Aim 1 the investigators will capture key stakeholder&#xD;
      perspectives about challenges in collocated school mental health services through formative&#xD;
      work to inform collaborative planning and capacity building activities in Aim 2. Then, in Aim&#xD;
      2 the investigators will identify inter-organizational challenges and required components of&#xD;
      TeamSTEPPS to adapt. The investigators will establish an advisory board and adapt TeamSTEPPS.&#xD;
      The product of Aim 2 will be an adapted TeamSTEPPS, directed toward both school mental health&#xD;
      and school-employed personnel, and specific, tailored implementation strategies to improve&#xD;
      services in schools in conjunction with TeamSTEPPS. Finally, In Aim 3 the investigators will&#xD;
      explore the feasibility, acceptability, and utility of TeamSTEPPS and the strategies&#xD;
      generated in Aim 2 on inter-professional collaboration, teamwork, and student outcomes in&#xD;
      eight schools.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 23, 2022</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Intervention Measure (FIM)</measure>
    <time_frame>3-12 months</time_frame>
    <description>Reliable and validated 4-item tool to assess perceptions of the feasibility of an intervention (in this caseTeamSTEPPS). Scores can range from 4 to 20. A score of 4 indicates it was very unfeasible and a score of 20 indicates it was very feasible. Each item may be scored 1 = &quot;completely disagree&quot;, 2 = &quot;disagree&quot;, 3 = &quot;neither agree nor disagree&quot;, 4 = &quot;agree&quot;, and 5 = &quot;completely agree.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Intervention Measure (AIM)</measure>
    <time_frame>3-12 months</time_frame>
    <description>Reliable and validated 4-item observational tool to assess perceptions of the acceptability of an intervention (in this caseTeamSTEPPS). Scores can range from 4 to 20. A score of 4 indicates it was very unacceptable and a score of 20 indicates it was very acceptable. Each item may be scored 1 = &quot;completely disagree&quot;, 2 = &quot;disagree&quot;, 3 = &quot;neither agree nor disagree&quot;, 4 = &quot;agree&quot;, and 5 = &quot;completely agree.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford Non-Technical Skills (NOTECHS) scale</measure>
    <time_frame>3-12 months</time_frame>
    <description>Validated 4-item tool to assess teamwork and cognitive skills. It measures leadership and management; teamwork and cooperation; problem-solving and decision making; and situational awareness. An observer codes team behavior in each domain using 3-5 items rated from 1 (Below Standard) to 4 (Excellent). Sub-team specific modifiers further examine the unique contributions of various staff roles. It has been previously modified for use with medical teams with demonstrated reliability and validity. Final scores indicate &quot;below standard&quot;, &quot;basic standard&quot;, &quot;standard&quot;, or &quot;excellent&quot; performance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Expanded School Mental Health Collaboration Instrument</measure>
    <time_frame>3-12 months</time_frame>
    <description>59-item tool to assess perceptions of three aspects of collaboration (i.e., types, influences, and benefits) between school professionals and mental health professionals from collaborating agencies on a continuous scale. For each subscale, an average score is calculated with higher scores indicating strengths and lower scores indicating areas to consider improving or targeting. Responses for all items on the scale are measured on one of two, four-point Likert-type scales (1 = never to 4 = often for Types of Collaboration; and 1 = strongly disagree to 4 = strongly agree for Influences on Collaboration and Perceived Benefits of Collaboration). Mental health team members will complete the Community version. School personnel will complete School version.</description>
  </other_outcome>
  <other_outcome>
    <measure>TeamSTEPPS Teamwork Perceptions Questionnaire (T-TPQ)</measure>
    <time_frame>3-12 months</time_frame>
    <description>Self-report measure of individual perceptions of group-level team skills and behavior. It is based upon the five core components of teamwork that comprise TeamSTEPPS. Each construct is represented by seven questions, totaling 35 items. Items are rated continuously on a five-point scale from strongly disagree = 1 to strongly agree = 5. A total score is computed by summing all items and higher scores indicate more favorable perceptions.</description>
  </other_outcome>
  <other_outcome>
    <measure>TeamSTEPPS Teamwork Attitudes Questionnaire (T-TAQ)</measure>
    <time_frame>3-12 months</time_frame>
    <description>Self-report measure of individual attitudes related to the core components of teamwork captured within TeamSTEPPS. Six items measure each of the core teamwork constructs, for a total of 30 items. Items are rated continuously on a five-point scale from strongly disagree = 1 to strongly agree = 5. A sum score is calculated across items with higher scores indicating more positive attitudes.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Child Behavior Problem</condition>
  <condition>Multidisciplinary Communication</condition>
  <condition>Interprofessional Relations</condition>
  <arm_group>
    <arm_group_label>Schools implementing TeamSTEPPS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select schools will take a participatory approach to collaboratively identify solutions to challenges in collocated school-based mental health services based upon the feedback of stakeholders and use TeamSTEPPS to support mental health team-school collaboration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TeamSTEPPS</intervention_name>
    <description>TeamSTEPPS is an evidence-based approach for teams that can be adapted for school mental health.&#xD;
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS), has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is designed to build competencies in the areas of leadership, situation monitoring, mutual support, and communication and has been associated with improvements in teamwork and communication as well as patient outcomes, such as decreased seclusion in psychiatric hospitals.</description>
    <arm_group_label>Schools implementing TeamSTEPPS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be one of the following: mental health providers, teachers, leaders from schools&#xD;
             (e.g., principals), leaders from community mental health agencies (i.e., executive&#xD;
             directors, clinical supervisors), and leadership personnel from the payer or partner&#xD;
             school district.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria proposed for school and agency-employed personnel.&#xD;
             Participants will not be excluded given their gender, demographics, and/or past&#xD;
             experience.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Courtney Benjamin Wolk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Courtney Benjamin Wolk, PhD</last_name>
    <phone>215-746-6099</phone>
    <email>Courtney.Wolk@pennmedicine.upenn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Courtney Benjamin Wolk, PhD</last_name>
      <email>courtney.wolk@pennmedicine.upenn.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>school-based mental health</keyword>
  <keyword>TeamSTEPPS</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>We will make data from our trial available for other researchers by uploading it to the National Clinical Trials Database. The proposed research will include data from 95 school mental health providers, teachers, and administrators and supervisors overseeing school mental health services in Philadelphia public schools. The final dataset will include quantitative (socio-demographic characteristics, school characteristics, outcomes, and contextual predictors of implementation) data. We will collect identifiers required to create a Global Unique Identifier (GUID) that will allow for inclusions in the National Database of Clinical Trials. We also will include recommended language in our consent forms related to obtain participant permission to upload their data to the National Database.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The descriptive data will be uploaded every six months during data collection periods of the study. All other data will be submitted at time of the publication of the manuscripts describing our main findings.</ipd_time_frame>
    <ipd_access_criteria>Any data directly shared with other investigators would entail a data-use agreement, signed by the research team, our system partners, and the individual(s) requesting data, and that accounts for (1) commitment to using the data only for research and as outlined and approved in the agreement; (2) IRB approval at the host institution, (3) a plan for securing the data using appropriate technology, and (4) an agreed upon plan to destroy or return the data upon completion. In such cases, we will make the data and associated documentation available to users under our own auspices, such as by sending an encrypted hard-drive to users.</ipd_access_criteria>
  </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/NCT04440228
org study id: 834488
nct id: NCT04440228
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an
      evidence-based approach for teams that can be adapted for school mental health. TeamSTEPPS
      has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is
      designed to build competencies in the areas of leadership, situation monitoring, mutual
      support, and communication and has been associated with improvements in teamwork and
      communication as well as patient outcomes, such as decreased seclusion in psychiatric
      hospitals. This approach has yet to be extended as an implementation strategy in school or
      community mental health teams. If an evidence-based team approach like TeamSTEPPS can be
      successfully applied to school mental health teams, it could provide a cost-effective
      strategy for improving student mental health services and bolstering existing EBP
      implementation efforts, which to date generally have been insufficient in producing long-term
      clinician behavior change. In Aim 1 the investigators will capture key stakeholder
      perspectives about challenges in collocated school mental health services through formative
      work to inform collaborative planning and capacity building activities in Aim 2. Then, in Aim
      2 the investigators will identify inter-organizational challenges and required components of
      TeamSTEPPS to adapt. The investigators will establish an advisory board and adapt TeamSTEPPS.
      The product of Aim 2 will be an adapted TeamSTEPPS, directed toward both school mental health
      and school-employed personnel, and specific, tailored implementation strategies to improve
      services in schools in conjunction with TeamSTEPPS. Finally, In Aim 3 the investigators will
      explore the feasibility, acceptability, and utility of TeamSTEPPS and the strategies
      generated in Aim 2 on inter-professional collaboration, teamwork, and student outcomes in
      eight schools.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility of Intervention Measure (FIM)
time frame: 3-12 months
description: Reliable and validated 4-item tool to assess perceptions of the feasibility of an intervention (in this caseTeamSTEPPS). Scores can range from 4 to 20. A score of 4 indicates it was very unfeasible and a score of 20 indicates it was very feasible. Each item may be scored 1 = "completely disagree", 2 = "disagree", 3 = "neither agree nor disagree", 4 = "agree", and 5 = "completely agree."
measure: Acceptability of Intervention Measure (AIM)
time frame: 3-12 months
description: Reliable and validated 4-item observational tool to assess perceptions of the acceptability of an intervention (in this caseTeamSTEPPS). Scores can range from 4 to 20. A score of 4 indicates it was very unacceptable and a score of 20 indicates it was very acceptable. Each item may be scored 1 = "completely disagree", 2 = "disagree", 3 = "neither agree nor disagree", 4 = "agree", and 5 = "completely agree."
measure: Oxford Non-Technical Skills (NOTECHS) scale
time frame: 3-12 months
description: Validated 4-item tool to assess teamwork and cognitive skills. It measures leadership and management; teamwork and cooperation; problem-solving and decision making; and situational awareness. An observer codes team behavior in each domain using 3-5 items rated from 1 (Below Standard) to 4 (Excellent). Sub-team specific modifiers further examine the unique contributions of various staff roles. It has been previously modified for use with medical teams with demonstrated reliability and validity. Final scores indicate "below standard", "basic standard", "standard", or "excellent" performance.
measure: Expanded School Mental Health Collaboration Instrument
time frame: 3-12 months
description: 59-item tool to assess perceptions of three aspects of collaboration (i.e., types, influences, and benefits) between school professionals and mental health professionals from collaborating agencies on a continuous scale. For each subscale, an average score is calculated with higher scores indicating strengths and lower scores indicating areas to consider improving or targeting. Responses for all items on the scale are measured on one of two, four-point Likert-type scales (1 = never to 4 = often for Types of Collaboration; and 1 = strongly disagree to 4 = strongly agree for Influences on Collaboration and Perceived Benefits of Collaboration). Mental health team members will complete the Community version. School personnel will complete School version.
measure: TeamSTEPPS Teamwork Perceptions Questionnaire (T-TPQ)
time frame: 3-12 months
description: Self-report measure of individual perceptions of group-level team skills and behavior. It is based upon the five core components of teamwork that comprise TeamSTEPPS. Each construct is represented by seven questions, totaling 35 items. Items are rated continuously on a five-point scale from strongly disagree = 1 to strongly agree = 5. A total score is computed by summing all items and higher scores indicate more favorable perceptions.
measure: TeamSTEPPS Teamwork Attitudes Questionnaire (T-TAQ)
time frame: 3-12 months
description: Self-report measure of individual attitudes related to the core components of teamwork captured within TeamSTEPPS. Six items measure each of the core teamwork constructs, for a total of 30 items. Items are rated continuously on a five-point scale from strongly disagree = 1 to strongly agree = 5. A sum score is calculated across items with higher scores indicating more positive attitudes.
arm group label: Schools implementing TeamSTEPPS
arm group type: Experimental
description: Select schools will take a participatory approach to collaboratively identify solutions to challenges in collocated school-based mental health services based upon the feedback of stakeholders and use TeamSTEPPS to support mental health team-school collaboration.
intervention type: Behavioral
intervention name: TeamSTEPPS
description: TeamSTEPPS is an evidence-based approach for teams that can be adapted for school mental health.
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS), has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is designed to build competencies in the areas of leadership, situation monitoring, mutual support, and communication and has been associated with improvements in teamwork and communication as well as patient outcomes, such as decreased seclusion in psychiatric hospitals.
arm group label: Schools implementing TeamSTEPPS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Courtney Benjamin Wolk, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Courtney Benjamin Wolk, PhD
phone: 215-746-6099
email: Courtney.Wolk@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Problem Behavior
sharing ipd: Yes
ipd description: We will make data from our trial available for other researchers by uploading it to the National Clinical Trials Database. The proposed research will include data from 95 school mental health providers, teachers, and administrators and supervisors overseeing school mental health services in Philadelphia public schools. The final dataset will include quantitative (socio-demographic characteristics, school characteristics, outcomes, and contextual predictors of implementation) data. We will collect identifiers required to create a Global Unique Identifier (GUID) that will allow for inclusions in the National Database of Clinical Trials. We also will include recommended language in our consent forms related to obtain participant permission to upload their data to the National Database.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The descriptive data will be uploaded every six months during data collection periods of the study. All other data will be submitted at time of the publication of the manuscripts describing our main findings.
ipd access criteria: Any data directly shared with other investigators would entail a data-use agreement, signed by the research team, our system partners, and the individual(s) requesting data, and that accounts for (1) commitment to using the data only for research and as outlined and approved in the agreement; (2) IRB approval at the host institution, (3) a plan for securing the data using appropriate technology, and (4) an agreed upon plan to destroy or return the data upon completion. In such cases, we will make the data and associated documentation available to users under our own auspices, such as by sending an encrypted hard-drive to users.