<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/NCT03791281</url>
  </required_header>
  <id_info>
    <org_study_id>52139</org_study_id>
    <secondary_id>1R21MH108714</secondary_id>
    <nct_id>NCT03791281</nct_id>
  </id_info>
  <brief_title>Beliefs and Attitudes for Successful Implementation in Schools (BASIS)</brief_title>
  <official_title>Beliefs and Attitudes for Successful Implementation in Schools (BASIS)</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>
  </sponsors>
  <source>University of Washington</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 goal of this study is to adapt and test the feasibility and potential efficacy of a&#xD;
      theory-driven pre-implementation intervention to address individual-level barriers to EBP&#xD;
      implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) -&#xD;
      designed to improve school mental health providers' implementation of EBPs. BASIS is intended&#xD;
      to be a feasible and scalable first-line or adjunctive implementation enhancement&#xD;
      intervention that is facilitative of other efforts (e.g., organizational interventions) that&#xD;
      target high quality EBP implementation. Aims of this study are to: (1) Adapt an existing,&#xD;
      theory-driven implementation intervention (BASIS), previously used with educators, to improve&#xD;
      the EBP implementation behaviors of school mental health providers; and (2) Assess the&#xD;
      viability of a later clinical trial by: (a) establishing the feasibility, acceptability, and&#xD;
      appropriateness of the BASIS intervention among school mental health providers, and (b) Pilot&#xD;
      testing BASIS, as compared to an Attention Control, delivered as pre-implementation&#xD;
      intervention prior to training in a specific, existing EBP. Key organizational factors (e.g.,&#xD;
      implementation climate) will also be evaluated and included as covariates and we will explore&#xD;
      trends in the data to inform the design of a larger trial. Ultimately, BASIS offers an&#xD;
      innovative and scalable approach to improving school mental health providers' uptake and use&#xD;
      of EBPs in order to increase the number of youth with mental health problems who receive high&#xD;
      quality services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2016</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Attitudes toward Evidence-Based Practices</measure>
    <time_frame>Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up</time_frame>
    <description>Evidence-Based Practice Attitudes Scale (EBPAS) is a widely used 26-item tool designed to assess evidence-based practice (EBP) attitudes with items measured on a 0-4 scale and 6 subscales: (1) likelihood of adopting if the EBP were a requirement; (2) likelihood of adopting if the EBP were appealing to you; (3) openness to new practices; (4) perceived divergence between current practices and EBPs; (5) fit of EBPs with current practices; and (6) burden of EBPs. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect more favorable attitudes (perceived divergence is reverse-coded).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Subjective Norms</measure>
    <time_frame>Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up</time_frame>
    <description>Subjective Norms Scale is based on Theory of Planned Behavior (TPB) constructs. Two subscales measure two types implementation-related subjective norms: injunctive norms and descriptive norms. Four items load on each subscale and mean score range from -3 to +3, with positive scores reflecting more positive subjective injunctive and descriptive norms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Behavioral Control</measure>
    <time_frame>Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up</time_frame>
    <description>Perceived Behavioral Control Scale is a modified version of the Teacher's Self-Efficacy Scale, which has 10 items assessing perceived behavioral control in implementing evidence-based practices. Items are scored on a 1-4 scale with a total mean score ranging from 1-4. Higher scores reflect greater (i.e., more favorable) perceived behavioral control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in School Implementation Citizenship Behaviors</measure>
    <time_frame>Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up</time_frame>
    <description>The School Implementation Citizenship Behaviors Scale (S-ICBS) includes 15 items and measures clinicians' perceptions of how school staff engage with evidence-based practices in their specific school context. There are 4 subscales: (1) helping others; (2) keeping informed; (3) taking initiative; and (4) advocacy. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect greater (i.e., more favorable) implementation citizenship behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intentions to Implement</measure>
    <time_frame>Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up</time_frame>
    <description>The Modified Intentions to Use Scale has 9 items assessing school mental health providers' intentions to implement evidence-based practices. A total mean score is computed with a range of 0-4 and higher scores indicate more favorable intentions. Two versions of this scale were administered. At baseline, all providers were asked about general intentions to implement evidence-based practices. After training, clinicians were asked about intentions to implement the specific intervention for which they had received training.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Intervention Adoption</condition>
  <condition>Implementation</condition>
  <arm_group>
    <arm_group_label>BASIS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received a 3-hour BASIS implementation strategy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Received a 3-hour session designed to control for dose, information provided, and presenter effects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BASIS</intervention_name>
    <arm_group_label>BASIS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
        School mental health providers (school psychologists, school social workers, etc.)&#xD;
        recruited from middle and high schools in two economically and ethnically diverse districts&#xD;
        in the Seattle area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron R Lyon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington School Mental Health Assessment, Research, and Training (SMART) Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115-8160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 29, 2018</last_update_submitted>
  <last_update_submitted_qc>December 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</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>
  <keyword>pre-implementation intervention</keyword>
  <keyword>implementation strategy</keyword>
  <keyword>individual-level barriers</keyword>
  <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/NCT03791281
org study id: 52139
secondary id: 1R21MH108714
nct id: NCT03791281
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to adapt and test the feasibility and potential efficacy of a
      theory-driven pre-implementation intervention to address individual-level barriers to EBP
      implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) -
      designed to improve school mental health providers' implementation of EBPs. BASIS is intended
      to be a feasible and scalable first-line or adjunctive implementation enhancement
      intervention that is facilitative of other efforts (e.g., organizational interventions) that
      target high quality EBP implementation. Aims of this study are to: (1) Adapt an existing,
      theory-driven implementation intervention (BASIS), previously used with educators, to improve
      the EBP implementation behaviors of school mental health providers; and (2) Assess the
      viability of a later clinical trial by: (a) establishing the feasibility, acceptability, and
      appropriateness of the BASIS intervention among school mental health providers, and (b) Pilot
      testing BASIS, as compared to an Attention Control, delivered as pre-implementation
      intervention prior to training in a specific, existing EBP. Key organizational factors (e.g.,
      implementation climate) will also be evaluated and included as covariates and we will explore
      trends in the data to inform the design of a larger trial. Ultimately, BASIS offers an
      innovative and scalable approach to improving school mental health providers' uptake and use
      of EBPs in order to increase the number of youth with mental health problems who receive high
      quality services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Change in Attitudes toward Evidence-Based Practices
time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
description: Evidence-Based Practice Attitudes Scale (EBPAS) is a widely used 26-item tool designed to assess evidence-based practice (EBP) attitudes with items measured on a 0-4 scale and 6 subscales: (1) likelihood of adopting if the EBP were a requirement; (2) likelihood of adopting if the EBP were appealing to you; (3) openness to new practices; (4) perceived divergence between current practices and EBPs; (5) fit of EBPs with current practices; and (6) burden of EBPs. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect more favorable attitudes (perceived divergence is reverse-coded).
measure: Change in Subjective Norms
time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
description: Subjective Norms Scale is based on Theory of Planned Behavior (TPB) constructs. Two subscales measure two types implementation-related subjective norms: injunctive norms and descriptive norms. Four items load on each subscale and mean score range from -3 to +3, with positive scores reflecting more positive subjective injunctive and descriptive norms.
measure: Change in Perceived Behavioral Control
time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
description: Perceived Behavioral Control Scale is a modified version of the Teacher's Self-Efficacy Scale, which has 10 items assessing perceived behavioral control in implementing evidence-based practices. Items are scored on a 1-4 scale with a total mean score ranging from 1-4. Higher scores reflect greater (i.e., more favorable) perceived behavioral control.
measure: Change in School Implementation Citizenship Behaviors
time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
description: The School Implementation Citizenship Behaviors Scale (S-ICBS) includes 15 items and measures clinicians' perceptions of how school staff engage with evidence-based practices in their specific school context. There are 4 subscales: (1) helping others; (2) keeping informed; (3) taking initiative; and (4) advocacy. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect greater (i.e., more favorable) implementation citizenship behavior.
measure: Change in Intentions to Implement
time frame: Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up
description: The Modified Intentions to Use Scale has 9 items assessing school mental health providers' intentions to implement evidence-based practices. A total mean score is computed with a range of 0-4 and higher scores indicate more favorable intentions. Two versions of this scale were administered. At baseline, all providers were asked about general intentions to implement evidence-based practices. After training, clinicians were asked about intentions to implement the specific intervention for which they had received training.
arm group label: BASIS
arm group type: Experimental
description: Received a 3-hour BASIS implementation strategy.
arm group label: Attention Control
arm group type: Active Comparator
description: Received a 3-hour session designed to control for dose, information provided, and presenter effects.
intervention type: Behavioral
intervention name: BASIS
arm group label: BASIS
intervention type: Behavioral
intervention name: Attention Control
arm group label: Attention Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron R Lyon, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
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
sharing ipd: No