<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/NCT04451161</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00008401</org_study_id>
    <secondary_id>1R01MH119148-01A1</secondary_id>
    <nct_id>NCT04451161</nct_id>
  </id_info>
  <brief_title>A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy</brief_title>
  <official_title>A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This research project is a hybrid type 2 effectiveness-implementation trial that&#xD;
      simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in&#xD;
      the education sector and (2) the impact of a theory-driven pragmatic implementation strategy&#xD;
      designed to increase the adoption, fidelity, and sustainment of evidence-based treatments&#xD;
      (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test&#xD;
      the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in&#xD;
      a new setting that increases access to mental health care - schools (Aim 1); test the cost&#xD;
      effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for&#xD;
      Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms&#xD;
      and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data&#xD;
      collection to explain residuals (i.e., clinicians whose implementation behavior is&#xD;
      unaccounted for by the mediation model) (Aim 2c).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 27, 2020</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The care provider is not masked to the intervention condition they are in (ie, TF-CBT vs TAU), but will be masked to the implementation strategy (ie, Attention Control vs. BASIS).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>TF-CBT Adoption</measure>
    <time_frame>18 Months</time_frame>
    <description>Adoption is operationalized as the initiation of a clinican's first TF-CBT session at any point during study participation. These data will be collected from an online TF-CBT &quot;Toolkit&quot; that facilitates tracking of services delivered and has been commonly used for large-scale TF-CBT implementation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child PTSD Symptom Scale for DSM-V</measure>
    <time_frame>6 Months</time_frame>
    <description>The CPSS-SR-5 is a modified version of Child PTSD Symptom Scale self-report (CPSS-SR) for DSM-5. The 20 PTSD symptom items are rated on a 5-point scale of frequency and severity from 0 (not at all) to 4 (6 or more times a week /severe). The 7 functioning items are rated on yes/no.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood and Feelings Questionnaire - Short</measure>
    <time_frame>6 Months</time_frame>
    <description>The SMFQ consists of a series of descriptive phrases regarding how the subject has been feeling or acting recently. Codings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all in the past two weeks.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Evidence-Based Practices</condition>
  <condition>CBT</condition>
  <condition>School Health Services</condition>
  <condition>Trauma, Psychological</condition>
  <arm_group>
    <arm_group_label>BASIS with TF-CBT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools)&#xD;
Clinical Intervention: experimental arm (Trauma-Focused CBT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AC with TF-CBT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Implementation intervention: control arm&#xD;
Clinical Intervention: experimental arm (Trauma-Focused CBT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Implementation intervention: non-applicable&#xD;
Clinical Intervention: control arm (Enhanced TAU)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Beliefs and Attitudes for Successful Implementation in Schools (BASIS)</intervention_name>
    <description>BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.</description>
    <arm_group_label>BASIS with TF-CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma-Focused Cognitive-Behavioral Therapy</intervention_name>
    <description>TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.</description>
    <arm_group_label>AC with TF-CBT</arm_group_label>
    <arm_group_label>BASIS with TF-CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.</description>
    <arm_group_label>Enhanced Treatment as Usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform</description>
    <arm_group_label>AC with TF-CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinicians will be included if they (a) provide school-based services in a participating&#xD;
        district; (b) have not previously received formal training in TF-CBT; and (c) are not&#xD;
        actively receiving support to implement another trauma-focused intervention.&#xD;
&#xD;
        Students subjects will meet TF-CBT eligibility criteria, including (a) be within the TF-CBT&#xD;
        developmental range (grades 3 -12), (b) have traumatic event exposure (e.g., exposure to&#xD;
        violence), and (c) significant post-traumatic stress symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Lyon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clayton Cook, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Coifman</last_name>
    <phone>206-543-6483</phone>
    <email>jcoifman@uw.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ian Muse</last_name>
    <email>imuse@uw.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Coifman, MA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Aaron Lyon</investigator_full_name>
    <investigator_title>Associate Professor, School of Medicine: Psychiatry: Childrens Division</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Psychological Trauma</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/NCT04451161
org study id: STUDY00008401
secondary id: 1R01MH119148-01A1
nct id: NCT04451161
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research project is a hybrid type 2 effectiveness-implementation trial that
      simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in
      the education sector and (2) the impact of a theory-driven pragmatic implementation strategy
      designed to increase the adoption, fidelity, and sustainment of evidence-based treatments
      (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test
      the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in
      a new setting that increases access to mental health care - schools (Aim 1); test the cost
      effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for
      Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms
      and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data
      collection to explain residuals (i.e., clinicians whose implementation behavior is
      unaccounted for by the mediation model) (Aim 2c).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
masking description: The care provider is not masked to the intervention condition they are in (ie, TF-CBT vs TAU), but will be masked to the implementation strategy (ie, Attention Control vs. BASIS).
measure: TF-CBT Adoption
time frame: 18 Months
description: Adoption is operationalized as the initiation of a clinican's first TF-CBT session at any point during study participation. These data will be collected from an online TF-CBT "Toolkit" that facilitates tracking of services delivered and has been commonly used for large-scale TF-CBT implementation.
measure: Child PTSD Symptom Scale for DSM-V
time frame: 6 Months
description: The CPSS-SR-5 is a modified version of Child PTSD Symptom Scale self-report (CPSS-SR) for DSM-5. The 20 PTSD symptom items are rated on a 5-point scale of frequency and severity from 0 (not at all) to 4 (6 or more times a week /severe). The 7 functioning items are rated on yes/no.
measure: Mood and Feelings Questionnaire - Short
time frame: 6 Months
description: The SMFQ consists of a series of descriptive phrases regarding how the subject has been feeling or acting recently. Codings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all in the past two weeks.
arm group label: BASIS with TF-CBT
arm group type: Other
description: Implementation intervention: experimental arm (Beliefs and Attitudes for Successful Implementation in Schools)
Clinical Intervention: experimental arm (Trauma-Focused CBT)
arm group label: AC with TF-CBT
arm group type: Other
description: Implementation intervention: control arm
Clinical Intervention: experimental arm (Trauma-Focused CBT)
arm group label: Enhanced Treatment as Usual
arm group type: Other
description: Implementation intervention: non-applicable
Clinical Intervention: control arm (Enhanced TAU)
intervention type: Behavioral
intervention name: Beliefs and Attitudes for Successful Implementation in Schools (BASIS)
description: BASIS blended (i.e., multifaceted and protocolized) implementation strategy, which occurs at the beginning of active implementation. BASIS is designed to facilitate observable implementation outcomes, including EBP adoption and intervention fidelity, via strategic education, motivational Interviewing, and social influence strategies.
arm group label: BASIS with TF-CBT
intervention type: Behavioral
intervention name: Trauma-Focused Cognitive-Behavioral Therapy
description: TF-CBT is an evidence-based treatment that helps children from elementary to high school to address the negative effects of trauma and promote greater emotion and behavior regulation, including processing their traumatic memories, overcoming problematic thoughts and behaviors, and developing effective coping and interpersonal skills. It also includes a treatment component for parents or other caregivers. Parents can learn skills related to stress management, positive parenting, behavior management, and effective communication.
arm group label: AC with TF-CBT
arm group label: BASIS with TF-CBT
intervention type: Behavioral
intervention name: Treatment as Usual
description: Scaffolded intervention as usual. Includes: initial assessment of trauma symptoms, psychoeducation, follow-up planning and support.
arm group label: Enhanced Treatment as Usual
intervention type: Behavioral
intervention name: Attention Control
description: Didactic presentation of implementation-related content (e.g., information about the importance of implementing, definitions of key terms, etc.) to control for facilitator, dose, information provided, and delivery platform
arm group label: AC with TF-CBT
criteria: 
gender: All
minimum age: 7 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Lyon, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Clayton Cook, PhD
role: Principal Investigator
affiliation: University of Minnesota
last name: Jessica Coifman
phone: 206-543-6483
email: jcoifman@uw.edu
last name: Ian Muse
email: imuse@uw.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Aaron Lyon
investigator title: Associate Professor, School of Medicine: Psychiatry: Childrens Division
mesh term: Wounds and Injuries
mesh term: Psychological Trauma