<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/NCT04467034</url>
  </required_header>
  <id_info>
    <org_study_id>54817</org_study_id>
    <nct_id>NCT04467034</nct_id>
  </id_info>
  <brief_title>Evaluation of The Stanford Tobacco Prevention Toolkit</brief_title>
  <official_title>A Randomized Controlled Trial to Evaluate The Stanford Tobacco Prevention Toolkit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tobacco Related Disease Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford 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>
      The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by&#xD;
      educators and health professionals in providing tobacco-specific prevention education to&#xD;
      middle and high school students. The aims of this study are to determine: (1) whether the&#xD;
      Curriculum is effective in changing middle and high school students' resistance to using&#xD;
      tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco&#xD;
      products; and (2) whether the Curriculum is effective in changing middle and high school&#xD;
      students' actual use of tobacco in the short-term.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Schools were unable to participate due the COVID-19 pandemic, which shifted educational&#xD;
    priorities and therefore impeded school-based recruiting efforts. No participants were&#xD;
    enrolled.&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 15, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey</measure>
    <time_frame>Change from baseline to follow-up at approximately 40 weeks post-baseline</time_frame>
    <description>This survey measures change in resistance to use of tobacco products with questions related to the participant's intention to use tobacco.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey</measure>
    <time_frame>Change from baseline to follow-up at approximately 40 weeks post-baseline</time_frame>
    <description>This survey measures change in skills to refuse tobacco use with questions related to the participant's susceptibility to tobacco use, self-efficacy and self-confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge of tobacco products scaled score as measured by investigator-originated survey</measure>
    <time_frame>Change from baseline to follow-up at approximately 40 weeks post-baseline</time_frame>
    <description>This survey measures knowledge of tobacco products with questions related to the participant's knowledge of ingredients, of nicotine levels, of potential health outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>This survey measures use of tobacco products with questions related to the participant's ever tobacco use, past 30-day tobacco use, and past 7-day tobacco use.</measure>
    <time_frame>Change from baseline to follow-up at approximately 40 weeks post-baseline</time_frame>
    <description>Investigator-originated survey survey measures (questions) assess ever tobacco use, past 30-day tobacco use, past 7-day tobacco use This outcome measure assesses tobacco products use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Behavior, Health</condition>
  <condition>Behavior, Smoking</condition>
  <arm_group>
    <arm_group_label>Receives Stanford tobacco education curriculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stanford Tobacco Prevention Toolkit is administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Does not receive Stanford tobacco education curriculum</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receives another curriculum or no tobacco education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stanford Tobacco Prevention Toolkit curriculum</intervention_name>
    <description>Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.</description>
    <arm_group_label>Receives Stanford tobacco education curriculum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Middle school and high school students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non English-speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonnie L Halpern-Felsher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford School of Medicine, Department of Pediatrics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Baiocchi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford School of Medicine, Department of Epidemiology and Population Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://med.stanford.edu/tobaccopreventiontoolkit.html</url>
    <description>Stanford Tobacco Prevention Toolkit</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Bonnie Halpern-Felsher</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>young adults</keyword>
  <keyword>tobacco</keyword>
  <keyword>education</keyword>
  <keyword>health</keyword>
  <keyword>smoking</keyword>
  <keyword>prevention</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/NCT04467034
org study id: 54817
nct id: NCT04467034
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by
      educators and health professionals in providing tobacco-specific prevention education to
      middle and high school students. The aims of this study are to determine: (1) whether the
      Curriculum is effective in changing middle and high school students' resistance to using
      tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco
      products; and (2) whether the Curriculum is effective in changing middle and high school
      students' actual use of tobacco in the short-term.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey
time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
description: This survey measures change in resistance to use of tobacco products with questions related to the participant's intention to use tobacco.
measure: Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey
time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
description: This survey measures change in skills to refuse tobacco use with questions related to the participant's susceptibility to tobacco use, self-efficacy and self-confidence.
measure: Change in knowledge of tobacco products scaled score as measured by investigator-originated survey
time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
description: This survey measures knowledge of tobacco products with questions related to the participant's knowledge of ingredients, of nicotine levels, of potential health outcomes.
measure: This survey measures use of tobacco products with questions related to the participant's ever tobacco use, past 30-day tobacco use, and past 7-day tobacco use.
time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
description: Investigator-originated survey survey measures (questions) assess ever tobacco use, past 30-day tobacco use, past 7-day tobacco use This outcome measure assesses tobacco products use.
arm group label: Receives Stanford tobacco education curriculum
arm group type: Experimental
description: Stanford Tobacco Prevention Toolkit is administered.
arm group label: Does not receive Stanford tobacco education curriculum
arm group type: No Intervention
description: Receives another curriculum or no tobacco education.
intervention type: Behavioral
intervention name: Stanford Tobacco Prevention Toolkit curriculum
description: Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.
arm group label: Receives Stanford tobacco education curriculum
criteria: 
gender: All
minimum age: 11 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bonnie L Halpern-Felsher
role: Principal Investigator
affiliation: Stanford School of Medicine, Department of Pediatrics
last name: Michael Baiocchi
role: Principal Investigator
affiliation: Stanford School of Medicine, Department of Epidemiology and Population Health
facility: 
country: United States
url: https://med.stanford.edu/tobaccopreventiontoolkit.html
description: Stanford Tobacco Prevention Toolkit
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Bonnie Halpern-Felsher
investigator title: Professor of Pediatrics
sharing ipd: No