<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/NCT03799302</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA044745</org_study_id>
    <nct_id>NCT03799302</nct_id>
  </id_info>
  <brief_title>Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model</brief_title>
  <official_title>Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Social Learning Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Social Learning Center</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>
      This study aims to test the impact of an empirically derived implementation strategy-under&#xD;
      real-world conditions and across multiple child service systems-on successful adoption and&#xD;
      sustainment of two evidence-based programs that address adolescent substance abuse: Treatment&#xD;
      Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and&#xD;
      Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for&#xD;
      this study utilize &quot;technology-based approaches&quot; for &quot;implementing large-scale change.&quot;&#xD;
      Leveraging previous data focused on developing and testing the 8-staged Stages of&#xD;
      Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy&#xD;
      (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase&#xD;
      and testing the SIC-CS to support the adoption of new evidence-based programs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stages of Implementation Completion (SIC)</measure>
    <time_frame>Baseline through month 60</time_frame>
    <description>The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Evidence Based Practice</condition>
  <arm_group>
    <arm_group_label>Standard Consultation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIC Coaching Consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SIC Coaching</intervention_name>
    <description>Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.</description>
    <arm_group_label>SIC Coaching Consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Senior leadership staff from teams that either currently are sustaining or who achieve&#xD;
             1-year sustainment post certification during the first year of the project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Saldana, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Social Learning Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Saldana</last_name>
    <phone>541-485-2711</phone>
    <email>lisas@oslc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ted Donahue</last_name>
    <phone>541-285-2711</phone>
    <email>tedd@oslc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oregon Social Learning Center</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Courtenay Padgett</last_name>
      <phone>541-485-2711</phone>
      <email>courtp@oslc.org</email>
    </contact>
    <contact_backup>
      <last_name>Lisa Saldana, PhD</last_name>
      <phone>541-485-2711</phone>
      <email>lisas@oslc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Lisa Saldana, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Social Learning Center</investigator_affiliation>
    <investigator_full_name>Lisa Saldana</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03799302
org study id: R01DA044745
nct id: NCT03799302
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to test the impact of an empirically derived implementation strategy-under
      real-world conditions and across multiple child service systems-on successful adoption and
      sustainment of two evidence-based programs that address adolescent substance abuse: Treatment
      Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and
      Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for
      this study utilize "technology-based approaches" for "implementing large-scale change."
      Leveraging previous data focused on developing and testing the 8-staged Stages of
      Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy
      (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase
      and testing the SIC-CS to support the adoption of new evidence-based programs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Stages of Implementation Completion (SIC)
time frame: Baseline through month 60
description: The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability).
arm group label: Standard Consultation
arm group type: No Intervention
description: Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors
arm group label: SIC Coaching Consultation
arm group type: Experimental
description: In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP.
intervention type: Behavioral
intervention name: SIC Coaching
description: Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.
arm group label: SIC Coaching Consultation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Saldana, PHD
role: Principal Investigator
affiliation: Oregon Social Learning Center
last name: Lisa Saldana
phone: 541-485-2711
email: lisas@oslc.org
last name: Ted Donahue
phone: 541-285-2711
email: tedd@oslc.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Social Learning Center
investigator full name: Lisa Saldana
investigator title: Principal Investigator