<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/NCT04474158</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY18110082</org_study_id>
    <secondary_id>5R01MD013797-02</secondary_id>
    <nct_id>NCT04474158</nct_id>
  </id_info>
  <brief_title>Creating Peace: Community-based Youth Violence Prevention to Address Racism and Discrimination</brief_title>
  <official_title>Creating Peace: Community-based Youth Violence Prevention to Address Racism and Discrimination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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 cluster-randomized community-partnered study will examine the effectiveness of a&#xD;
      trauma-sensitive, gender transformative youth violence prevention program called Creating&#xD;
      Peace that integrates racism and discrimination prevention with youth ages 14-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This community-partnered cluster-randomized controlled trial will examine the effectiveness&#xD;
      of a trauma-sensitive, gender-transformative youth violence prevention program that&#xD;
      integrates racism and discrimination prevention.&#xD;
&#xD;
      Set in 24 neighborhoods in Pittsburgh, Pennsylvania with concentrated social and economic&#xD;
      disadvantage, this study addresses gender and racial injustice through a series of group&#xD;
      discussions, bringing together adolescents ages 14-19 with law enforcement officers in a&#xD;
      process of social restoration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>
    <intervention_model_description>This cluster-randomized community-partnered study will examine the effectiveness of a trauma-sensitive, gender transformative youth violence prevention program called Creating Peace that integrates racism and discrimination prevention among youth ages 14-19. The study will be located in Pittsburgh, Pennsylvania across 24 neighborhoods with concentrated disadvantage ('clusters'), randomized either to receive the &quot;Creating Peace&quot; program (i.e., intervention neighborhood, n=12) or to a job skills training program (n=12 schools).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in recent use of any violence at 3 months</measure>
    <time_frame>At baseline and three months after program conclusion</time_frame>
    <description>Summary score of any recent use of violence (physical, sexual, and emotional abuse; sexual violence; physical violence and threatening with a weapon; cyber dating abuse, cyber peer abuse, and sexting) calculated as one point for each behavior then summed (lower score indicates better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in recent use of any violence at 9 months</measure>
    <time_frame>At baseline and nine months after program.</time_frame>
    <description>Summary score of any recent use of violence (physical, sexual, and emotional abuse; sexual violence; physical violence and threatening with a weapon; cyber dating abuse, cyber peer abuse, and sexting) calculated as one point for each behavior then summed (lower score indicates better outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in past 30 day weapon carrying at 3 months</measure>
    <time_frame>At baseline and three months after program conclusion</time_frame>
    <description>Self-reported number of days they carried a weapon in past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in past 30 day weapon carrying at 9 months</measure>
    <time_frame>At baseline and nine months after program conclusion</time_frame>
    <description>Self-reported number of days they carried a weapon in past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in positive bystander behaviors at 3 months</measure>
    <time_frame>At baseline and three months after program conclusion</time_frame>
    <description>Past 3 month positive bystander behavior when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores. Participants report if they have witnessed peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior, provided support to person being harmed).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in positive bystander behaviors at 9 months</measure>
    <time_frame>At baseline and nine months after program conclusion</time_frame>
    <description>Past 3 month positive bystander behavior when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores. Participants report if they have witnessed peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior, provided support to person being harmed).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Adolescent Behavior</condition>
  <condition>Group, Peer</condition>
  <condition>Violence, Non-accidental</condition>
  <condition>Violence, Sexual</condition>
  <condition>Violence, Domestic</condition>
  <condition>Emotional Abuse</condition>
  <condition>Coping Skills</condition>
  <condition>Communication, Personal</condition>
  <arm_group>
    <arm_group_label>Creating Peace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Creating Peace uses a group discussion format with activities that explore race, gender, sexual identity, and social class. Creating Peace is a 12 session curriculum designed to support youth ages 14-19 in healing from experiences of trauma by restoring social connections, strengthening positive coping strategies that exclude all forms of violence, challenging gender norms that foster violence perpetration, and practicing positive bystander intervention skills to intervene safely with peers' disrespectful and harmful behaviors. Through 12 sessions (3 hours/session) over a 4 to 12 week period, Creating Peace offers gender transformative content combined with youth leadership development. Near program conclusion, youth will offer guidance to law enforcement on interacting with youth in a process of social restoration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Job Readiness Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Creating Peace</intervention_name>
    <description>Creating Peace is a 12 session curriculum designed to support youth ages 14-19 in healing from experiences of trauma by restoring social connections, strengthening positive coping strategies that exclude all forms of violence, challenging gender norms that foster violence perpetration, and practicing positive bystander intervention skills to intervene safely with peers' disrespectful and harmful behaviors. Through 12 sessions (3 hours/session) over a 4 to 12 week period, Creating Peace offers gender transformative content combined with youth leadership development. Near program conclusion, youth will offer guidance to law enforcement on interacting with youth in a process of social restoration.</description>
    <arm_group_label>Creating Peace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Job Readiness</intervention_name>
    <description>Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth.</description>
    <arm_group_label>Job Readiness Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be ages 14-19 (inclusive)&#xD;
&#xD;
          -  Participants must speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not ages 14-19 (inclusive)&#xD;
&#xD;
          -  Do not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants that self report any self-representation of gender identity to include, but not limited to, male, female, trans-male, trans-female or gender non conforming.</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Miller, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren Risser, MPH</last_name>
    <phone>412-692-8504</phone>
    <email>lauren.risser@chp.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ethan Copperman</last_name>
    <phone>412-692-6504</phone>
    <email>ethan.copperman2@chp.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Risser, MPH</last_name>
      <phone>412-692-8504</phone>
      <email>lauren.risser@chp.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ethan Copperman</last_name>
      <phone>412-692-8504</phone>
      <email>ethan.copperman2@chp.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Elizabeth Miller, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Elizabeth Miller</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The research team will not make individual participant data (IPD) available to other researchers.</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/NCT04474158
org study id: STUDY18110082
secondary id: 5R01MD013797-02
nct id: NCT04474158
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This cluster-randomized community-partnered study will examine the effectiveness of a
      trauma-sensitive, gender transformative youth violence prevention program called Creating
      Peace that integrates racism and discrimination prevention with youth ages 14-19.
This community-partnered cluster-randomized controlled trial will examine the effectiveness
      of a trauma-sensitive, gender-transformative youth violence prevention program that
      integrates racism and discrimination prevention.

      Set in 24 neighborhoods in Pittsburgh, Pennsylvania with concentrated social and economic
      disadvantage, this study addresses gender and racial injustice through a series of group
      discussions, bringing together adolescents ages 14-19 with law enforcement officers in a
      process of social restoration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This cluster-randomized community-partnered study will examine the effectiveness of a trauma-sensitive, gender transformative youth violence prevention program called Creating Peace that integrates racism and discrimination prevention among youth ages 14-19. The study will be located in Pittsburgh, Pennsylvania across 24 neighborhoods with concentrated disadvantage ('clusters'), randomized either to receive the "Creating Peace" program (i.e., intervention neighborhood, n=12) or to a job skills training program (n=12 schools).
primary purpose: Prevention
masking: None (Open Label)
measure: Change in recent use of any violence at 3 months
time frame: At baseline and three months after program conclusion
description: Summary score of any recent use of violence (physical, sexual, and emotional abuse; sexual violence; physical violence and threatening with a weapon; cyber dating abuse, cyber peer abuse, and sexting) calculated as one point for each behavior then summed (lower score indicates better outcome)
measure: Change in recent use of any violence at 9 months
time frame: At baseline and nine months after program.
description: Summary score of any recent use of violence (physical, sexual, and emotional abuse; sexual violence; physical violence and threatening with a weapon; cyber dating abuse, cyber peer abuse, and sexting) calculated as one point for each behavior then summed (lower score indicates better outcome)
measure: Change in past 30 day weapon carrying at 3 months
time frame: At baseline and three months after program conclusion
description: Self-reported number of days they carried a weapon in past 30 days
measure: Change in past 30 day weapon carrying at 9 months
time frame: At baseline and nine months after program conclusion
description: Self-reported number of days they carried a weapon in past 30 days
measure: Change in positive bystander behaviors at 3 months
time frame: At baseline and three months after program conclusion
description: Past 3 month positive bystander behavior when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores. Participants report if they have witnessed peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior, provided support to person being harmed).
measure: Change in positive bystander behaviors at 9 months
time frame: At baseline and nine months after program conclusion
description: Past 3 month positive bystander behavior when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores. Participants report if they have witnessed peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior, provided support to person being harmed).
arm group label: Creating Peace
arm group type: Experimental
description: Creating Peace uses a group discussion format with activities that explore race, gender, sexual identity, and social class. Creating Peace is a 12 session curriculum designed to support youth ages 14-19 in healing from experiences of trauma by restoring social connections, strengthening positive coping strategies that exclude all forms of violence, challenging gender norms that foster violence perpetration, and practicing positive bystander intervention skills to intervene safely with peers' disrespectful and harmful behaviors. Through 12 sessions (3 hours/session) over a 4 to 12 week period, Creating Peace offers gender transformative content combined with youth leadership development. Near program conclusion, youth will offer guidance to law enforcement on interacting with youth in a process of social restoration.
arm group label: Job Readiness Training
arm group type: Active Comparator
description: Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness.
intervention type: Behavioral
intervention name: Creating Peace
description: Creating Peace is a 12 session curriculum designed to support youth ages 14-19 in healing from experiences of trauma by restoring social connections, strengthening positive coping strategies that exclude all forms of violence, challenging gender norms that foster violence perpetration, and practicing positive bystander intervention skills to intervene safely with peers' disrespectful and harmful behaviors. Through 12 sessions (3 hours/session) over a 4 to 12 week period, Creating Peace offers gender transformative content combined with youth leadership development. Near program conclusion, youth will offer guidance to law enforcement on interacting with youth in a process of social restoration.
arm group label: Creating Peace
intervention type: Behavioral
intervention name: Job Readiness
description: Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth.
arm group label: Job Readiness Training
criteria: 
gender: All
gender based: Yes
gender description: Participants that self report any self-representation of gender identity to include, but not limited to, male, female, trans-male, trans-female or gender non conforming.
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Miller, MD, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Lauren Risser, MPH
phone: 412-692-8504
email: lauren.risser@chp.edu
last name: Ethan Copperman
phone: 412-692-6504
email: ethan.copperman2@chp.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Elizabeth Miller
investigator title: Professor
sharing ipd: No
ipd description: The research team will not make individual participant data (IPD) available to other researchers.