xml: <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/NCT05986188</url>
    </required_header>
    <id_info>
      <org_study_id>R01CE003536</org_study_id>
      <nct_id>NCT05986188</nct_id>
    </id_info>
    <brief_title>Evaluating a School-based Social and Material Needs Identification System to Prevent Youth Violence Involvement</brief_title>
    <official_title>Evaluating a School-based Social and Material Needs Identification System to Prevent Youth Violence Involvement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Wayne State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Texas-Arlington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</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 goal of this observational study is to evaluate the effects of Pathways to Potential&#xD;
        (P2P) on youth violence involvement in Michigan public K-12 students. The main goals of this&#xD;
        study are:&#xD;
  &#xD;
          -  This project will link longitudinal P2P participation data to state administrative&#xD;
             records and school disciplinary data to evaluate associations between school P2P&#xD;
             participation and youth outcomes-specifically chronic absenteeism, peer aggression&#xD;
             expulsions, and child maltreatment rates within a school (Aim 1).&#xD;
  &#xD;
          -  Given the focus of P2P is to improve the social and structural conditions within a&#xD;
             school that contribute to student chronic absenteeism, the team will assess if chronic&#xD;
             absenteeism rates mediate the relationships between school P2P participation and youth&#xD;
             violence involvement (Aim 2).&#xD;
  &#xD;
          -  Finally, a survey of success coaches will inform the examination of school and&#xD;
             implementation factors that moderate associations between P2P participation and youth&#xD;
             violence involvement (Aim 3).&#xD;
  &#xD;
        Schools participating in P2P receive Michigan Department of Health and Human Services (MDHHS)&#xD;
        caseworkers, called success coaches, in local elementary, middle, and high schools. After&#xD;
        identifying a social or material need that is a barrier to school attendance (e.g.,&#xD;
        transportation barriers, caregiver unemployment), success coaches connect students and&#xD;
        families to community resources and public assistance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Peer aggression expulsions</measure>
      <time_frame>Peer aggression expulsions will be measured for every academic school year from 2001 to 2022, possibly to 2024 depending on data availability</time_frame>
      <description>The state of Michigan requires all public schools to report expulsions for all students to the Michigan Department of Education (MDE), including the incident type(s) which led to the expulsion. Expulsions are instances in which the local educational agency removes a student from their regular school for disciplinary purposes for the remainder of the school year or longer. The investigators will consider expulsions for peer aggression as expulsions which included any of the following: 1) firearm possession-handgun; 2) firearm possession-rifle/shotgun; 3) firearm possession-other firearm; 4) other weapon possession; 5) bomb or similar threat; 6) arson; 7) physical violence with injury, or; 8) physical violence without injury. For each school, the study team will calculate the total number of peer aggression expulsions per school year.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Child maltreatment</measure>
      <time_frame>Peer aggression expulsions will be measured for every academic school year from 2001 to 2022, possibly to 2024 depending on data availability</time_frame>
      <description>The Michigan Statewide Automated Child Welfare Information System (MiSACWIS) includes dates of investigations into child maltreatment, names of alleged victims, and date of birth of alleged victims for all child maltreatment investigations in the state of Michigan. Investigators will link the MiSACWIS data to individual student data from MDE that includes information on student name, date of birth, schools of enrollment, and dates of school enrollment enrolled schools. The study team will use this linked dataset to calculate the number of child maltreatment investigations per school per school year.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronic absenteeism</measure>
      <time_frame>Chronic absenteeism will measured for every academic school year from 2004 to 2022, possibly to 2024 depending on data availability</time_frame>
      <description>A student is considered chronically absent if they miss 10% or more of school days in which they are enrolled at the school. For each school, the investigators will calculate the total number of students that were chronically absent via the data provided by MDE.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Firearm-involved expulsions</measure>
      <time_frame>Firearm-involved expulsions will be measured for every academic school year from 2001 to 2022, possibly to 2024 depending on data availability</time_frame>
      <description>In the state of Michigan, firearm possession on school grounds by a student requires the student to be expelled from the school. Expulsions for firearm possession on school grounds can be recorded as one or more of the following incident types: 1) firearm possession-handgun; 2) firearm possession-rifle/shotgun; 3) firearm possession-other firearm. The study team will consider any expulsions that included one of these types as a reason for expulsion as a firearm-involved expulsion. For each school, the study team will calculate the total number of firearm-involved expulsions per school year.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Violence, Physical</condition>
    <condition>Maltreatment, Child</condition>
    <arm_group>
      <arm_group_label>Implementing Schools</arm_group_label>
      <description>Implementing schools are public K-12 schools in the State of Michigan that participated in the Pathways to Potential program in a given year (from 2012 to 2024).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-implementing schools</arm_group_label>
      <description>Non-implementing schools are public K-12 schools in the State of Michigan that DID NOT participate in the Pathways to Potential program in a given year (from 2012 to 2024).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pathways to Potential</intervention_name>
      <description>Pathways to Potential stations MDHHS caseworkers, called success coaches, in local elementary, middle, and high schools. After identifying a social or material need that is a barrier to school attendance (e.g., transportation barriers, caregiver unemployment), success coaches connect students and families to community resources and public assistance.</description>
      <arm_group_label>Implementing Schools</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Almost all of the data used for analyses will come from secondary administrative datasets&#xD;
          acquired through Data Use Agreements with specific State of Michigan agencies (i.e.&#xD;
          Michigan Department of Health and Human Services and the Michigan Department of Education).&#xD;
  &#xD;
          The survey portion of this study will ONLY be administered to Success Coaches over the age&#xD;
          of 18 who are actively working inside of a K-12 public school at the time of the collection&#xD;
          period.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Administrative Data Inclusion Criteria:&#xD;
  &#xD;
            -  State of Michigan K-12 public school&#xD;
  &#xD;
            -  In person instruction&#xD;
  &#xD;
            -  Open to all students in District/area&#xD;
  &#xD;
          Administrative Data Exclusion Criteria:&#xD;
  &#xD;
            -  Private schools&#xD;
  &#xD;
            -  Virtual learning&#xD;
  &#xD;
            -  Needs-specific schools&#xD;
  &#xD;
          Survey Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age and older&#xD;
  &#xD;
            -  Working as a Success Coach inside a Michigan K-12 public school during the data&#xD;
               collection period&#xD;
  &#xD;
          Survey Exclusion Criteria:&#xD;
  &#xD;
            -  Former Success Coaches&#xD;
  &#xD;
            -  Success Coaches not working inside a Michigan K-12 public school during the data&#xD;
               collection period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebeccah L Sokol, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rebeccah L Sokol, PhD</last_name>
      <phone>7349364894</phone>
      <email>rlsokol@umich.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Victor Medina Del Toro, MA</last_name>
      <phone>7349364894</phone>
      <email>vmedina@umich.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Rebeccah Sokol</investigator_full_name>
      <investigator_title>Assistant Professor, School of Social Work</investigator_title>
    </responsible_party>
    <keyword>material needs</keyword>
    <keyword>social needs</keyword>
    <keyword>intervention</keyword>
    <keyword>school-based</keyword>
    <keyword>school violence</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data will not be shared with other researchers.&#xD;
  MDHHS P2P Data: The Data Use Agreement (DUA) stipulates that the data must only be used by members of the study team and that it must be destroyed at the conclusion of the study.&#xD;
  MDE K-12 Data: This dataset contains Personally Identifiable Information individual-level student data protected under FERPA. The dataset cannot be made publicly available without violating FERPA regulations, risking deductive disclosure, or violating the DUA.&#xD;
  MDHHS MiSACWIS Data: This dataset contains Personally Identifiable Information and sensitive details about child maltreatment investigations. The data cannot be made publicly available without risking deductive disclosure or violating the DUA.&#xD;
  Success Coach Survey data: The primary research data cannot be shared externally without risking deductive disclosure of the participants.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 2, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT05986188/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986188
  org study id: R01CE003536
  nct id: NCT05986188
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate the effects of Pathways to Potential
        (P2P) on youth violence involvement in Michigan public K-12 students. The main goals of this
        study are:
  
          -  This project will link longitudinal P2P participation data to state administrative
             records and school disciplinary data to evaluate associations between school P2P
             participation and youth outcomes-specifically chronic absenteeism, peer aggression
             expulsions, and child maltreatment rates within a school (Aim 1).
  
          -  Given the focus of P2P is to improve the social and structural conditions within a
             school that contribute to student chronic absenteeism, the team will assess if chronic
             absenteeism rates mediate the relationships between school P2P participation and youth
             violence involvement (Aim 2).
  
          -  Finally, a survey of success coaches will inform the examination of school and
             implementation factors that moderate associations between P2P participation and youth
             violence involvement (Aim 3).
  
        Schools participating in P2P receive Michigan Department of Health and Human Services (MDHHS)
        caseworkers, called success coaches, in local elementary, middle, and high schools. After
        identifying a social or material need that is a barrier to school attendance (e.g.,
        transportation barriers, caregiver unemployment), success coaches connect students and
        families to community resources and public assistance.
  observational model: Cohort
  time perspective: Retrospective
  measure: Peer aggression expulsions
  time frame: Peer aggression expulsions will be measured for every academic school year from 2001 to 2022, possibly to 2024 depending on data availability
  description: The state of Michigan requires all public schools to report expulsions for all students to the Michigan Department of Education (MDE), including the incident type(s) which led to the expulsion. Expulsions are instances in which the local educational agency removes a student from their regular school for disciplinary purposes for the remainder of the school year or longer. The investigators will consider expulsions for peer aggression as expulsions which included any of the following: 1) firearm possession-handgun; 2) firearm possession-rifle/shotgun; 3) firearm possession-other firearm; 4) other weapon possession; 5) bomb or similar threat; 6) arson; 7) physical violence with injury, or; 8) physical violence without injury. For each school, the study team will calculate the total number of peer aggression expulsions per school year.
  measure: Child maltreatment
  time frame: Peer aggression expulsions will be measured for every academic school year from 2001 to 2022, possibly to 2024 depending on data availability
  description: The Michigan Statewide Automated Child Welfare Information System (MiSACWIS) includes dates of investigations into child maltreatment, names of alleged victims, and date of birth of alleged victims for all child maltreatment investigations in the state of Michigan. Investigators will link the MiSACWIS data to individual student data from MDE that includes information on student name, date of birth, schools of enrollment, and dates of school enrollment enrolled schools. The study team will use this linked dataset to calculate the number of child maltreatment investigations per school per school year.
  measure: Chronic absenteeism
  time frame: Chronic absenteeism will measured for every academic school year from 2004 to 2022, possibly to 2024 depending on data availability
  description: A student is considered chronically absent if they miss 10% or more of school days in which they are enrolled at the school. For each school, the investigators will calculate the total number of students that were chronically absent via the data provided by MDE.
  measure: Firearm-involved expulsions
  time frame: Firearm-involved expulsions will be measured for every academic school year from 2001 to 2022, possibly to 2024 depending on data availability
  description: In the state of Michigan, firearm possession on school grounds by a student requires the student to be expelled from the school. Expulsions for firearm possession on school grounds can be recorded as one or more of the following incident types: 1) firearm possession-handgun; 2) firearm possession-rifle/shotgun; 3) firearm possession-other firearm. The study team will consider any expulsions that included one of these types as a reason for expulsion as a firearm-involved expulsion. For each school, the study team will calculate the total number of firearm-involved expulsions per school year.
  arm group label: Implementing Schools
  description: Implementing schools are public K-12 schools in the State of Michigan that participated in the Pathways to Potential program in a given year (from 2012 to 2024).
  arm group label: Non-implementing schools
  description: Non-implementing schools are public K-12 schools in the State of Michigan that DID NOT participate in the Pathways to Potential program in a given year (from 2012 to 2024).
  intervention type: Other
  intervention name: Pathways to Potential
  description: Pathways to Potential stations MDHHS caseworkers, called success coaches, in local elementary, middle, and high schools. After identifying a social or material need that is a barrier to school attendance (e.g., transportation barriers, caregiver unemployment), success coaches connect students and families to community resources and public assistance.
  arm group label: Implementing Schools
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rebeccah L Sokol, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Rebeccah L Sokol, PhD
  phone: 7349364894
  email: rlsokol@umich.edu
  last name: Victor Medina Del Toro, MA
  phone: 7349364894
  email: vmedina@umich.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Rebeccah Sokol
  investigator title: Assistant Professor, School of Social Work
  sharing ipd: No
  ipd description: Individual participant data will not be shared with other researchers.
  MDHHS P2P Data: The Data Use Agreement (DUA) stipulates that the data must only be used by members of the study team and that it must be destroyed at the conclusion of the study.
  MDE K-12 Data: This dataset contains Personally Identifiable Information individual-level student data protected under FERPA. The dataset cannot be made publicly available without violating FERPA regulations, risking deductive disclosure, or violating the DUA.
  MDHHS MiSACWIS Data: This dataset contains Personally Identifiable Information and sensitive details about child maltreatment investigations. The data cannot be made publicly available without risking deductive disclosure or violating the DUA.
  Success Coach Survey data: The primary research data cannot be shared externally without risking deductive disclosure of the participants.
  provided document: 