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/NCT06001892</url>
    </required_header>
    <id_info>
      <org_study_id>PREIS</org_study_id>
      <nct_id>NCT06001892</nct_id>
    </id_info>
    <brief_title>Tennessee Youth Prepared for Success</brief_title>
    <acronym>TYPS</acronym>
    <official_title>Tennessee Youth Prepared for Success- Be in Charge Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centerstone Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centerstone Research Institute</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 principal objective of Tennessee Youth Prepared for Success is to pilot, implement, and&#xD;
        test innovative adolescent pregnancy prevention strategies using a randomized controlled&#xD;
        trial (RCT) to effectively educate youth on both abstinence and contraception with the goal&#xD;
        of reducing youth pregnancies, births, and STIs. Tennessee Youth Prepared for Success will&#xD;
        address Adulthood Preparation Subjects (APS) to promote youths' successful and healthy&#xD;
        transition to adulthood; include a Positive Youth Development (PYD) approach to engage youth&#xD;
        and provide positive influences and skill building opportunities; and implement&#xD;
        activities/interventions within a trauma-informed approach to account for the mental health&#xD;
        needs of those who have experienced maltreatment, abuse, or violence. The project's goals and&#xD;
        principal and subordinate objectives align with the PREIS program's goals/objectives and&#xD;
        purpose, including (1) targeting high-risk youth to prevent pregnancy and STIs, including&#xD;
        HIV/AIDS; (2) rigorously evaluating interventions using an RCT; (3) manualizing/packaging&#xD;
        curriculum; and (4) disseminating lessons learned, best practices, and relevant findings.&#xD;
        Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural&#xD;
        counties in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural&#xD;
        youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth&#xD;
        (e.g., systems-involved).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Tennessee Youth Prepared for Success will implement a promising curricula Be In Charge (BIC)&#xD;
        for the treatment group, while the control group will receive the Adolescent Health&#xD;
        Curriculum. BIC is an abstinence-based sexual health education program developed by&#xD;
        Centerstone prevention staff in 2014 to increase a youth's sexual health knowledge and skills&#xD;
        for responsible decision-making. It is built upon the idea of building healthy relationship&#xD;
        skills and information to help inform responsible choices regarding sexual experiences, and&#xD;
        it has been refined since that time with input from key stakeholders from similar target&#xD;
        populations/geographic areas (e.g., youth, parents, school personnel). The 7 units of&#xD;
        curriculum fit in with the theory of planned behavior where the educational components of the&#xD;
        BiC intervention are designed to impact knowledge, attitudes, norms, and perceived control&#xD;
        over sexual health related outcomes (i.e., sexual intercourse and contraception usage),&#xD;
        ultimately influencing intention and behavior. The curricula is trauma-informed and integrate&#xD;
        a PYD approach through creation of safe environments, engagement of youth through creative&#xD;
        activities, and facilitation of progressive skill-building. Tennessee Youth Prepared for&#xD;
        Success will be guided by the Sexuality Information and Education Council of the United&#xD;
        States Guidelines for Comprehensive Sexuality Education, which assists sexual health&#xD;
        educators in delivering comprehensive, age/culturally/developmentally- appropriate and&#xD;
        medically accurate messages. Adulthood Preparation Subjects (APS) will be directed by ACF's&#xD;
        Adult Preparation Subjects Resource Guide.&#xD;
  &#xD;
        Primary research questions include: (1) Do behavioral intentions to delay sexual initiation&#xD;
        vary from pre-test to 1-year follow up? To what extent does this pattern vary based on&#xD;
        assigned treatment condition?; (2) What is the relationship between assigned treatment&#xD;
        condition and pregnancy rates reported at 1-year follow up?; (3) How does likelihood of&#xD;
        abstinence and contraception use change following delivery of the intervention? To what&#xD;
        extent does this vary based on assigned treatment condition? A series of secondary research&#xD;
        questions seek to understand outcomes related to implementation, theoretical constructs&#xD;
        associated with behavior, and life skill changes. The secondary questions include: (1) To&#xD;
        what degree were facilitators/educators able to implement the intervention/BiC with&#xD;
        fidelity?; and (2) How do sexual health knowledge (e.g., HIV/STIs, teen pregnancy), healthy&#xD;
        relationship skills, healthy life skills, attitudes/values about adolescent development, and&#xD;
        parent-child communication change over time for Tennessee Youth Prepared for Success&#xD;
        participants? How does this effect vary by mode of intervention (i.e., Be In Charge vs.&#xD;
        Adolescent Health Curriculum)? The proposed evaluation study seeks to establish the efficacy&#xD;
        of a teen pregnancy prevention program tailored to the specific needs of Tennessee Youth&#xD;
        Prepared for Success' population subgroups (e.g., rural youth), thus supporting efforts to&#xD;
        address health disparities in teenage pregnancies.&#xD;
  &#xD;
        In this randomized control, experimental study, participants will be randomly assigned to&#xD;
        receive either BIC (i.e., treatment group) or the Adolescent Health Curriculum (i.e.,&#xD;
        control/comparison group). Through comparison of key program outcomes, this project seeks to&#xD;
        establish that BIC is (1) more effective the Adolescent Health Curriculum in decreasing&#xD;
        pregnancy rates, delaying sexual initiation, and increasing abstinence/contraception use and&#xD;
        (2) implemented with a higher degree of fidelity, reflective of its tailoring to current&#xD;
        medical accuracy standards and subpopulation needs. Classrooms/community groups will be&#xD;
        matched at the organizational level to mitigate confounding variables (e.g., geographic area,&#xD;
        age, demographics).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2026</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>Single (Participant)</masking>
      <masking_description>Participants will be masked during consent and baseline data collection. They will know the intervention once it begins.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Sexual activity</measure>
      <time_frame>baseline and six months</time_frame>
      <description>Number of participants who have abstained from sexual intercourse in the last three months, change from baseline at six months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sexting</measure>
      <time_frame>baseline and six months</time_frame>
      <description>Number of participants who have abstained from sending nude images in the last three months, change from baseline at six months</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Adolescent Behavior</condition>
    <condition>Adolescent Problem Behavior</condition>
    <condition>Risk Reduction</condition>
    <arm_group>
      <arm_group_label>Be in Charge</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The 7 units of curriculum fit in with the theory of planned behavior where the educational components of the BiC intervention are designed to impact knowledge, attitudes, norms, and perceived control over sexual health related outcomes (i.e., sexual intercourse and contraception usage), ultimately influencing intention and behavior. The curricula is trauma-informed and integrate a PYD approach through creation of safe environments, engagement of youth through creative activities, and facilitation of progressive skill-building.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adolescent Health Curricula</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Adolescent Health Curriculum which is designed to navigate youth through the emotional components of adolescence in preparation for adulthood.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tennessee Youth Prepared for Success</intervention_name>
      <description>both 5 day classroom interventions.</description>
      <arm_group_label>Adolescent Health Curricula</arm_group_label>
      <arm_group_label>Be in Charge</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  have a signed consent form from a guardian, along with assent or consent forms from&#xD;
               the youth, as appropriate based on age, unless deemed otherwise by the Institutional&#xD;
               Review Board (IRB)&#xD;
  &#xD;
            -  be free of debilitating intellectual, mental health, or cognitive impairment (i.e.&#xD;
               psychosis, orientation to time/place, etc. based on screening at program entry)&#xD;
  &#xD;
            -  be willing to share their experiences with sexual health &amp; wellbeing training&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  younger than 14 or older 19&#xD;
  &#xD;
            -  those with debilitating intellectual, mental health, or cognitive impairment&#xD;
  &#xD;
            -  those without consent at the time of data collection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jordan L Nelon, PhD, MPH</last_name>
      <phone>2147332946</phone>
      <email>jordan.nelon@centerstone.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>adolescent pregnancy prevention</keyword>
    <keyword>adult preparation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Problem Behavior</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 6, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT06001892/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT06001892/ICF_001.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/NCT06001892
  org study id: PREIS
  nct id: NCT06001892
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The principal objective of Tennessee Youth Prepared for Success is to pilot, implement, and
        test innovative adolescent pregnancy prevention strategies using a randomized controlled
        trial (RCT) to effectively educate youth on both abstinence and contraception with the goal
        of reducing youth pregnancies, births, and STIs. Tennessee Youth Prepared for Success will
        address Adulthood Preparation Subjects (APS) to promote youths' successful and healthy
        transition to adulthood; include a Positive Youth Development (PYD) approach to engage youth
        and provide positive influences and skill building opportunities; and implement
        activities/interventions within a trauma-informed approach to account for the mental health
        needs of those who have experienced maltreatment, abuse, or violence. The project's goals and
        principal and subordinate objectives align with the PREIS program's goals/objectives and
        purpose, including (1) targeting high-risk youth to prevent pregnancy and STIs, including
        HIV/AIDS; (2) rigorously evaluating interventions using an RCT; (3) manualizing/packaging
        curriculum; and (4) disseminating lessons learned, best practices, and relevant findings.
        Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural
        counties in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural
        youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth
        (e.g., systems-involved).
  Tennessee Youth Prepared for Success will implement a promising curricula Be In Charge (BIC)
        for the treatment group, while the control group will receive the Adolescent Health
        Curriculum. BIC is an abstinence-based sexual health education program developed by
        Centerstone prevention staff in 2014 to increase a youth's sexual health knowledge and skills
        for responsible decision-making. It is built upon the idea of building healthy relationship
        skills and information to help inform responsible choices regarding sexual experiences, and
        it has been refined since that time with input from key stakeholders from similar target
        populations/geographic areas (e.g., youth, parents, school personnel). The 7 units of
        curriculum fit in with the theory of planned behavior where the educational components of the
        BiC intervention are designed to impact knowledge, attitudes, norms, and perceived control
        over sexual health related outcomes (i.e., sexual intercourse and contraception usage),
        ultimately influencing intention and behavior. The curricula is trauma-informed and integrate
        a PYD approach through creation of safe environments, engagement of youth through creative
        activities, and facilitation of progressive skill-building. Tennessee Youth Prepared for
        Success will be guided by the Sexuality Information and Education Council of the United
        States Guidelines for Comprehensive Sexuality Education, which assists sexual health
        educators in delivering comprehensive, age/culturally/developmentally- appropriate and
        medically accurate messages. Adulthood Preparation Subjects (APS) will be directed by ACF's
        Adult Preparation Subjects Resource Guide.
  
        Primary research questions include: (1) Do behavioral intentions to delay sexual initiation
        vary from pre-test to 1-year follow up? To what extent does this pattern vary based on
        assigned treatment condition?; (2) What is the relationship between assigned treatment
        condition and pregnancy rates reported at 1-year follow up?; (3) How does likelihood of
        abstinence and contraception use change following delivery of the intervention? To what
        extent does this vary based on assigned treatment condition? A series of secondary research
        questions seek to understand outcomes related to implementation, theoretical constructs
        associated with behavior, and life skill changes. The secondary questions include: (1) To
        what degree were facilitators/educators able to implement the intervention/BiC with
        fidelity?; and (2) How do sexual health knowledge (e.g., HIV/STIs, teen pregnancy), healthy
        relationship skills, healthy life skills, attitudes/values about adolescent development, and
        parent-child communication change over time for Tennessee Youth Prepared for Success
        participants? How does this effect vary by mode of intervention (i.e., Be In Charge vs.
        Adolescent Health Curriculum)? The proposed evaluation study seeks to establish the efficacy
        of a teen pregnancy prevention program tailored to the specific needs of Tennessee Youth
        Prepared for Success' population subgroups (e.g., rural youth), thus supporting efforts to
        address health disparities in teenage pregnancies.
  
        In this randomized control, experimental study, participants will be randomly assigned to
        receive either BIC (i.e., treatment group) or the Adolescent Health Curriculum (i.e.,
        control/comparison group). Through comparison of key program outcomes, this project seeks to
        establish that BIC is (1) more effective the Adolescent Health Curriculum in decreasing
        pregnancy rates, delaying sexual initiation, and increasing abstinence/contraception use and
        (2) implemented with a higher degree of fidelity, reflective of its tailoring to current
        medical accuracy standards and subpopulation needs. Classrooms/community groups will be
        matched at the organizational level to mitigate confounding variables (e.g., geographic area,
        age, demographics).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Participants will be masked during consent and baseline data collection. They will know the intervention once it begins.
  measure: Sexual activity
  time frame: baseline and six months
  description: Number of participants who have abstained from sexual intercourse in the last three months, change from baseline at six months
  measure: Sexting
  time frame: baseline and six months
  description: Number of participants who have abstained from sending nude images in the last three months, change from baseline at six months
  arm group label: Be in Charge
  arm group type: Experimental
  description: The 7 units of curriculum fit in with the theory of planned behavior where the educational components of the BiC intervention are designed to impact knowledge, attitudes, norms, and perceived control over sexual health related outcomes (i.e., sexual intercourse and contraception usage), ultimately influencing intention and behavior. The curricula is trauma-informed and integrate a PYD approach through creation of safe environments, engagement of youth through creative activities, and facilitation of progressive skill-building.
  arm group label: Adolescent Health Curricula
  arm group type: Active Comparator
  description: Adolescent Health Curriculum which is designed to navigate youth through the emotional components of adolescence in preparation for adulthood.
  intervention type: Behavioral
  intervention name: Tennessee Youth Prepared for Success
  description: both 5 day classroom interventions.
  arm group label: Adolescent Health Curricula
  arm group label: Be in Charge
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 19 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jordan L Nelon, PhD, MPH
  phone: 2147332946
  email: jordan.nelon@centerstone.org
  responsible party type: Sponsor
  mesh term: Problem Behavior
  sharing ipd: No
  provided document: 
  provided document: 