<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/NCT03820609</url>
  </required_header>
  <id_info>
    <org_study_id>HappyPeopleGames</org_study_id>
    <nct_id>NCT03820609</nct_id>
  </id_info>
  <brief_title>Interactive Digital Intervention to Prevent Violence Among Young Adults</brief_title>
  <official_title>Interactive Digital Intervention to Prevent Violence Among Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Happy People Games, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clemson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Happy People Games, LLC</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>
      The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change&#xD;
      for mobile devices, and to document the technical merit, commercial viability, and proof of&#xD;
      concept of the product. Successful completion of this proposal will result in the creation of&#xD;
      two assets: 1) an &quot;Intervention Manual&quot; that (similar to a logic model) will align key game&#xD;
      mechanics with theory and behavior change goals and, 2) the digital application for mobile&#xD;
      devices. Focus groups and interviews with students, as well as interviews with campus&#xD;
      stakeholders, will be used to inform development of the digital application and ensure its&#xD;
      commercial viability. A non-randomized open trial with a 1-month follow up will assess&#xD;
      preliminary effects on attitudes and behaviors, and will establish procedures for assessing&#xD;
      change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale&#xD;
      evaluation in a Phase 2 SBIR proposal. This line of research and development has the&#xD;
      potential to develop a commercially viable product with high public health impact that can be&#xD;
      disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to&#xD;
      high schools, clinics and military settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sexual assault (SA) is prevalent among students at 2- and 4-year colleges. The rate of SA&#xD;
      among college students is three times greater than the rate in the general population, making&#xD;
      prevention on college campuses a public health priority. There are no college SA prevention&#xD;
      programs that document reductions in SA in a rigorous research design. Digital applications&#xD;
      that use the theory and strategies of serious games integrate proven theories of behavior&#xD;
      change (social cognitive theory, self-determination theory) to produce sustained, measurable&#xD;
      behavioral outcomes, and are effective for promoting change in a range of health behaviors.&#xD;
      Digital applications have high market potential in light of widespread use of mobile devices&#xD;
      among young adults. Problematically, there are no commercially-available digital applications&#xD;
      for SA prevention with efficacy in reducing SA. Accordingly, in this proposal, the&#xD;
      Interactive Digital Intervention to Prevent Violence among Young Adults team will design,&#xD;
      create and pilot the Make a Change digital application. Make a Change is a universal&#xD;
      prevention program that aligns with best-practices in prevention, utilizes the theory and&#xD;
      strategies of serious games for health, and addresses risk and protective factors for SA&#xD;
      across the social ecology of individual, peer and community factors that foster SA. This&#xD;
      novel digital application also leverages theories of behavior change within serious games for&#xD;
      health, and integrates successful practices in videogame design to promote engagement,&#xD;
      learning and skill-building. This team consists of experts in SA prevention, commercial&#xD;
      videogame production, the development and testing of serious games for health, and business&#xD;
      development and marketing. The primary aim of this Phase I SBIR is to create and test an&#xD;
      alpha version of Make a Change for mobile devices, and to document the technical merit,&#xD;
      commercial viability, and proof of concept of the product. Successful completion of this&#xD;
      proposal will result in the creation of two assets: 1) an &quot;Intervention Manual&quot; that (similar&#xD;
      to a logic model) will align key game mechanics with theory and behavior change goals and, 2)&#xD;
      the digital application for mobile devices. Focus groups and interviews with students, as&#xD;
      well as interviews with campus stakeholders, will be used to inform development of the&#xD;
      digital application and ensure its commercial viability. A non-randomized open trial with a&#xD;
      1-month follow up will assess preliminary effects on attitudes and behaviors, and will&#xD;
      establish procedures for assessing change in proximal (attitude) and distal (behavioral)&#xD;
      outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of&#xD;
      research and development has the potential to develop a commercially viable product with high&#xD;
      public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year&#xD;
      colleges, and readily adapted to high schools, clinics and military settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2018</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">July 15, 2018</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>
    <intervention_model_description>A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The outcome evaluation is a non-randomized open pilot trial. Therefore, all participants and project collaborators are aware that individuals enrolled in the study are asked to complete the prevention program.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual aggression</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Sexual Experiences Survey - Revised</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexual victimization</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Sexual Experiences Survey - Revised</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bystander intervention</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Bystander Attitudes Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rape supportive beliefs</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Short-Form Illinois Rape Myth Acceptance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of peer support for sexual aggression</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assess through items from Boeringer's Social Norms Measure and Clemson's Peer Pressure Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived peer norms</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Change in the accuracy in perception of peer norms (assessed via responses to in-app questions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bystander intervention confidence</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Bystander Efficacy Scale from ARC-3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communication of consent</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Consent Experiences Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-protective behavior</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Alcohol Use Self-Protective Behavior Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological barriers to resistance</measure>
    <time_frame>1-month follow-up</time_frame>
    <description>Assessed via the Psychological Barriers to Resistance Instrument</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Sexual Assault</condition>
  <arm_group>
    <arm_group_label>Digital Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Make a Change is a universal sexual assault (SA) prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Intervention</intervention_name>
    <description>This digital application for sexual assault prevention can be completed on a tablet computer.</description>
    <arm_group_label>Digital Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 24&#xD;
&#xD;
          -  Enrolled as a student at one of the study sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Wood</last_name>
    <role>Principal Investigator</role>
    <affiliation>Happy People Games</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community College of Rhode Island</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clemson University</name>
      <address>
        <city>Clemson</city>
        <state>South Carolina</state>
        <zip>29634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sexual Assault</keyword>
  <keyword>Digital Intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no IPD sharing plan.</ipd_description>
  </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/NCT03820609
org study id: HappyPeopleGames
nct id: NCT03820609
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change
      for mobile devices, and to document the technical merit, commercial viability, and proof of
      concept of the product. Successful completion of this proposal will result in the creation of
      two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game
      mechanics with theory and behavior change goals and, 2) the digital application for mobile
      devices. Focus groups and interviews with students, as well as interviews with campus
      stakeholders, will be used to inform development of the digital application and ensure its
      commercial viability. A non-randomized open trial with a 1-month follow up will assess
      preliminary effects on attitudes and behaviors, and will establish procedures for assessing
      change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale
      evaluation in a Phase 2 SBIR proposal. This line of research and development has the
      potential to develop a commercially viable product with high public health impact that can be
      disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to
      high schools, clinics and military settings.
Sexual assault (SA) is prevalent among students at 2- and 4-year colleges. The rate of SA
      among college students is three times greater than the rate in the general population, making
      prevention on college campuses a public health priority. There are no college SA prevention
      programs that document reductions in SA in a rigorous research design. Digital applications
      that use the theory and strategies of serious games integrate proven theories of behavior
      change (social cognitive theory, self-determination theory) to produce sustained, measurable
      behavioral outcomes, and are effective for promoting change in a range of health behaviors.
      Digital applications have high market potential in light of widespread use of mobile devices
      among young adults. Problematically, there are no commercially-available digital applications
      for SA prevention with efficacy in reducing SA. Accordingly, in this proposal, the
      Interactive Digital Intervention to Prevent Violence among Young Adults team will design,
      create and pilot the Make a Change digital application. Make a Change is a universal
      prevention program that aligns with best-practices in prevention, utilizes the theory and
      strategies of serious games for health, and addresses risk and protective factors for SA
      across the social ecology of individual, peer and community factors that foster SA. This
      novel digital application also leverages theories of behavior change within serious games for
      health, and integrates successful practices in videogame design to promote engagement,
      learning and skill-building. This team consists of experts in SA prevention, commercial
      videogame production, the development and testing of serious games for health, and business
      development and marketing. The primary aim of this Phase I SBIR is to create and test an
      alpha version of Make a Change for mobile devices, and to document the technical merit,
      commercial viability, and proof of concept of the product. Successful completion of this
      proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar
      to a logic model) will align key game mechanics with theory and behavior change goals and, 2)
      the digital application for mobile devices. Focus groups and interviews with students, as
      well as interviews with campus stakeholders, will be used to inform development of the
      digital application and ensure its commercial viability. A non-randomized open trial with a
      1-month follow up will assess preliminary effects on attitudes and behaviors, and will
      establish procedures for assessing change in proximal (attitude) and distal (behavioral)
      outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of
      research and development has the potential to develop a commercially viable product with high
      public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year
      colleges, and readily adapted to high schools, clinics and military settings.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal.
primary purpose: Prevention
masking: None (Open Label)
masking description: The outcome evaluation is a non-randomized open pilot trial. Therefore, all participants and project collaborators are aware that individuals enrolled in the study are asked to complete the prevention program.
measure: Sexual aggression
time frame: 1-month follow-up
description: Assessed via the Sexual Experiences Survey - Revised
measure: Sexual victimization
time frame: 1-month follow-up
description: Assessed via the Sexual Experiences Survey - Revised
measure: Bystander intervention
time frame: 1-month follow-up
description: Assessed via the Bystander Attitudes Survey
measure: Rape supportive beliefs
time frame: 1-month follow-up
description: Assessed via the Short-Form Illinois Rape Myth Acceptance Scale
measure: Perception of peer support for sexual aggression
time frame: 1-month follow-up
description: Assess through items from Boeringer's Social Norms Measure and Clemson's Peer Pressure Measure
measure: Perceived peer norms
time frame: 1-month follow-up
description: Change in the accuracy in perception of peer norms (assessed via responses to in-app questions)
measure: Bystander intervention confidence
time frame: 1-month follow-up
description: Assessed via the Bystander Efficacy Scale from ARC-3
measure: Communication of consent
time frame: 1-month follow-up
description: Assessed via the Consent Experiences Scale
measure: Self-protective behavior
time frame: 1-month follow-up
description: Assessed via the Alcohol Use Self-Protective Behavior Scale
measure: Psychological barriers to resistance
time frame: 1-month follow-up
description: Assessed via the Psychological Barriers to Resistance Instrument
arm group label: Digital Intervention
arm group type: Experimental
description: Make a Change is a universal sexual assault (SA) prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building.
intervention type: Behavioral
intervention name: Digital Intervention
description: This digital application for sexual assault prevention can be completed on a tablet computer.
arm group label: Digital Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon Wood
role: Principal Investigator
affiliation: Happy People Games
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: There is no IPD sharing plan.