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/NCT05988398</url>
    </required_header>
    <id_info>
      <org_study_id>22811</org_study_id>
      <secondary_id>1U01CE003405-01</secondary_id>
      <nct_id>NCT05988398</nct_id>
    </id_info>
    <brief_title>Preventing Commercial Sexual Exploitation of Children</brief_title>
    <acronym>Project LIVE</acronym>
    <official_title>Rigorous Evaluation of the READY to Stand Curriculum as a Tool to Prevent the Commercial Sexual Exploitation of Children Among Racially and Ethnically Diverse Urban Youth (PHASE II: OPEN PILOT TRIAL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nebraska Lincoln</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Set Me Free Project</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Des Moines Public Schools</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Nebraska Lincoln</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 overall goal of the 5-year project is to conduct both a process and rigorous outcome&#xD;
        evaluation of The Set Me Free Projects (SMFP) READY to Stand (RTS) curriculum with an eye&#xD;
        toward widespread dissemination to other U.S. communities, if deemed effective.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Detailed Description: The commercial sexual exploitation of children (CSEC) is a public&#xD;
        health crisis in the U.S.1-4 Research has documented risk and protective factors across the&#xD;
        social ecology for CSEC,2,5-8 that many perpetrators (traffickers, clients, recruiters) of&#xD;
        CSEC are peers (e.g., romantic partners) 9-11 and adolescents report opportunities to&#xD;
        intervene in situations of peer victimization (although not necessarily specific to&#xD;
        CSEC).12-14 Prevention efforts with adolescents that seek to (1) reduce risk for CSEC&#xD;
        perpetration; (2) reduce risk for CSEC victimization; and (3) increase positive bystander&#xD;
        intervention in situations of CSEC is urgently needed. Thus, the goal of this&#xD;
        multi-stakeholder collaboration-that includes researchers, educators, practitioners, and&#xD;
        youth-is to conduct both a process and rigorous outcome evaluation of The Set Me Free&#xD;
        Project's© (SMFP) READY to Stand (RTS)© curriculum-with an eye toward widespread&#xD;
        dissemination to other U.S. communities, if deemed effective. This project is responsive to&#xD;
        Research Priority Area 4 (preventing CSEC as a form of CSA) of RFA-CE-22-003. The&#xD;
        implementation site includes eight high schools in Des Moines Public Schools (DMPS); students&#xD;
        (naïve to the RTS curriculum) are largely racial/ethnic minority (65%) and low-income (76%).&#xD;
        DMPS leadership have expressed a growing concern about the CSEC in their district and are&#xD;
        eager to partner with researchers to rigorously evaluate the RTS curriculum. The RTS&#xD;
        curriculum includes four, 45-minute modules implemented to high school students in mixed&#xD;
        gender groups of ~25 students and provides students with psychoeducation on CSEC, healthy&#xD;
        relationship skills training, identification of safe people/resources, and programming&#xD;
        components to enhance valuing of self and others. As part of the proposed project, the RTS&#xD;
        curriculum will be enhanced with two additional 45-minute modules on bystander intervention&#xD;
        training in situations of CSEC and shifting school norms to be intolerant of all forms of&#xD;
        violence, including CSEC. Additionally, school personnel participate in an enhanced (from 90&#xD;
        minutes to 120 minutes) training to equip them with skills to effectively respond to&#xD;
        students' disclosures of CSEC and to reinforce programming messages. The RTS curriculum may&#xD;
        also reduce other forms of violence such as teen dating violence (TDV) given it addresses&#xD;
        risk and protective factors for multiple forms of violence. Despite its potential for&#xD;
        reducing CSEC, the RTS curriculum has never been evaluated. Specific Aims are as follows:&#xD;
        Refinement and Planning Phase (Component A): Convene a Research Advisory Board (RAB) that&#xD;
        includes researchers, practitioners, educators, caregivers, and youth who will provide input&#xD;
        on all research components of the project (Aim 1a). Conduct focus groups with students (n=80)&#xD;
        and school personnel (n=60) to inform the refinement of the RTS curriculum and research&#xD;
        procedures for Component B (Aim 1b). Enhance the existing RTS program manual and create a&#xD;
        training manual to ensure consistent implementation, produce training manuals for use in&#xD;
        subsequent clinical trials and dissemination, and develop fidelity measures (Aim 1c). Develop&#xD;
        via cognitive interviews (n=20 youth, n=10 school personnel) and surveys (n=878) with&#xD;
        students valid, reliable, and developmentally appropriate measures of CSEC perpetration, CSEC&#xD;
        victimization, and CSEC bystander opportunity/action to be used in subsequent research,&#xD;
        including Component B (Aim 1d). Conduct an open pilot trial of the RTS curriculum in one of&#xD;
        the five traditional high schools and one of the three alternative schools in DMPS with&#xD;
        students (n=878) and school personnel (n=78) to gain experience with the recruitment and&#xD;
        assessment procedures and administration of the intervention; assess acceptability and safety&#xD;
        of the research protocols; document initial trends, effect sizes, and CSEC incidence rates;&#xD;
        and refine the intervention and research procedures in preparation for Component B (Aim 1e).&#xD;
        Apply for additional funding under Component B and disseminate findings to diverse audiences&#xD;
        in collaboration with the RAB (Aim 1f). All procedures for Component B will be ready for&#xD;
        implementation by the end of Component A funding. Rigorous Evaluation Phase (Component B):&#xD;
        Conduct a quasi-experimental study in which four traditional high schools in DMPS and two&#xD;
        alternative high schools (not including the two high schools that participated in Component&#xD;
        A) are demographically matched and randomly assigned to treatment or wait-list control&#xD;
        conditions. Students (n=7,241) will complete baseline and 6-, 12-, and 18-month follow-up&#xD;
        surveys to test the hypothesis that participation in the RTS program will lead to reductions&#xD;
        in CSEC perpetration (primary outcome), as well as reductions in CSEC victimization and TDV&#xD;
        and sexual violence victimization and perpetration and increases in bystander intervention in&#xD;
        CSEC situations compared to participants in the waitlist control condition (secondary&#xD;
        outcomes) (Aim 2a). We will assess mediators and demographic moderators of program impact&#xD;
        (Aim 2b). Document via program observations of student and school personnel programming (Aim&#xD;
        2c), post-session surveys (n=7,241 students; n=396 school personnel) (Aim 2d), and&#xD;
        post-program implementation key informant and stakeholder interviews (n=40: program&#xD;
        facilitators [n=10], students [n=20], school personnel [n=10]) (Aim 2e) variations in&#xD;
        implementation, unanticipated challenges, lessons learned, and perceptions of program impact.&#xD;
        Determine costs associated with the program implementation (both student and school personnel&#xD;
        programming) to inform future economic evaluation of the RTS curriculum (Aim 2f). Refine and&#xD;
        assess validity and reliability of school personnel's' CSEC prevention related knowledge,&#xD;
        attitudes, and skills (Aim 1g). Examine the preliminary impact of the RTS school personnel&#xD;
        training curriculum on CSEC prevention related knowledge, attitudes, and skills as well as&#xD;
        acceptability and perceptions of impact (Aim 1h).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Two Schools will receive the intervention in addition to pre- and post- surveys. There is no control group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in CSEC Perpetration and Victimization (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Students' self-reports of experiencing CSEC perpetration and victimization.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in School Personnel's CSEC prevention related knowledge, attitudes, skills and cultural humility. (SCHOOL PERSONNEL)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Knowledge of Sex Trafficking Perpetration and Victimization, Sex Trafficking bystander Opportunity and action, Sex Trafficking Bystander Efficacy, CSEC Knowledge, Bystander Readiness to Help, Social Norms, Prevention related Conversations with School Personnel, Cultural humility, and Program acceptability, feasibility, and perceptions of impact and attitudes towards sustainability will be measured via pre-test (baseline) and post-test (1 month after RTS delivery).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Bystander Intervention in situations of CSEC (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Students' self-reports of witnessing or experiencing CSEC perpetration and victimization as well as contextual and relational details for perpetration and victimization, and disclosure of CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Sexual Violence (SV) Perpetration and Victimization (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Students' self-reports of witnessing or hearing about topics relating to teen dating violence will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Dating Violence (MARSHA), Youth Violence (YRBS), Attitudes Towards Dating Violence (Acceptance of Couples Violence Scale), Green Dot and Bringing in the Bystander (BTIB).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Teen Dating Violence (TDV) Perpetration and Victimization (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Students' self-reports of witnessing or hearing about topics relating to CSEC, sex trafficking, sexual harassment, stalking, and dating violence and what their follow-up actions were, if any, will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Dating Violence (MARSHA), Youth Violence (YRBS), Attitudes Towards Dating Violence (Acceptance of Couples Violence Scale).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in Knowledge of CSEC (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Commercial Sexual Exploitation of Children - Youth Self Report Survey (CSEC-YSRS), youth's knowledge of rates, causes, and outcomes of CSEC, and recognizing what constitutes as CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour).</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Valuing Self and Others (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Students perceived self-worth and values, deserving to be treated with respect, Sexual and reproductive empowerment, Attitudes towards dating violence and acceptability of couple violence will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from measures and conceptualizations of PYD and dignity, Empowerment (Sexual and reproductive empowerment scale for adolescents and young adults), Developmental Assets Scale, Positive Identity subscales, Social Competencies subscales.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Healthy Relationship Skills (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Recognizing what are respectful, non-abusive and non-exploitative relationships as well as behavioral signs that don't constitute a health relationship will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Communication Skills Test, Sexual Communication Self-Efficacy Scale, Social-Emotional Competence Questionnaire (SECQ), and Relationship Management subscale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Prevention-related Communication with School Personnel (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Conversations with school personnels about health relationships, valuing self and others, healthy relationship skills, CSEC, dating violence, and/or bystander interventions will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from BITB and Youth VIP study.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Bystander Readiness to Help in Situations of CSEC (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Understanding of safe and effective interventions in situations of CSEC, and ability to recognize and intervene to prevent CSEC and deter youths in situations of CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Readiness to Help Scale (D-RHS), and Denial subscale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Perceptions of Social Norms of Prevention of CSEC (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Understanding of safe and effective interventions in situations of CSEC, and ability to recognize and intervene to prevent CSEC and deter youths in situations of CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Readiness to Help Scale (D-RHS), and Denial subscale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Control Variables (STUDENTS)</measure>
      <time_frame>Baseline and 1 month post RTS delivery.</time_frame>
      <description>Moderators and mediators will be assessed and measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Comprehensive Measure of Adverse Childhood Experience-Child Self-Report Version, Homelessness (CDC YRBS), Family Involvement in Sex Trade, Depression (PHQ-9), Alcohol use, Life Experiences Survey (System Involvement), and Academic and Career Commitment.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">956</enrollment>
    <condition>Sex Trafficking</condition>
    <condition>Sex Crimes</condition>
    <condition>Commercial Sex</condition>
    <condition>Sexual Violence</condition>
    <condition>Child Abuse, Sexual</condition>
    <condition>Sex Offense</condition>
    <arm_group>
      <arm_group_label>RTS Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>RTS intervention will include a total of one 120-minute session of programming delivered to school personnel, and six, 45-minute sessions (total = 4.5 hours) for students. There are five components in this intervention that both students and school personnels will receive: 1) Psychoeducation on CSEC, 2) Healthy relationship skills training, 3) Programming components to enhance valuing of self and others, 4) Bystander intervention skills, and 5) Social norms for both students and school personnel. Students will additionally receive programming on Identification of safe people and resources, while school personnel will receive programming on Responding to Student Disclosures, and Cultural Humility.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>READY To Stand Curriculum</intervention_name>
      <description>Students will receive the RTS programming over six consecutive school days, spread over two weeks. The program is delivered in mixed-gender groups of 20 to 40 students and includes videos, small and large group discussions, activities, worksheets, and ample opportunities for skill-building. This curriculum is intended to be one piece of comprehensive prevention strategies that has the potential to make immediate and sustained impacts on reducing rates of CSEC perpetration in the lives of youth, including those most vulnerable to this pernicious crime.</description>
      <arm_group_label>RTS Intervention</arm_group_label>
      <other_name>RTS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For school personnel, participants must be 18 years of age or older and currently&#xD;
               employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS&#xD;
               for the survey development portion of the study (Aim 1g). We will include anyone&#xD;
               working in administration (e.g., principal), teaching (e.g., academic subject matter&#xD;
               instructor) or support service (e.g., counselor) capacity within any of the eight high&#xD;
               schools encompassed within Des Moines Public School (DMPS) system.&#xD;
  &#xD;
            -  For students, participants must be in Grades 9 through 12 at one of the eight&#xD;
               participating high schools in DMPS and be able to understand spoken English. For the&#xD;
               OPT (Aims 1e, 1h) this includes Hoover and All Points.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For school personnel, not being 18 or older or currently employed at Hoover or All&#xD;
               Points for the OPT and one of the eight high schools in DMPS.&#xD;
  &#xD;
            -  For students, being in Grades younger than 9 or older than 12 and not being enrolled&#xD;
               in participating high school in DMPS.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katie M Edwards, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Nebraska Lincoln</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rochelle Dalla, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Nebraska Lincoln</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lorey Wheeler, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Nebraska Lincoln</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aleesa K Nutting, MA</last_name>
      <phone>5154106536</phone>
      <email>anutting2@unl.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katie M Edwards, PhD</last_name>
      <phone>603-422-3207</phone>
      <email>katie.edwards@unl.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>All Points Academy</name>
        <address>
          <city>Des Moines</city>
          <state>Iowa</state>
          <zip>50309</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Staciei Nessa</last_name>
        <phone>515-778-1972</phone>
        <email>stacie.nessa@dmschools.org</email>
      </contact>
      <contact_backup>
        <last_name>Jenn Stalder</last_name>
        <phone>5153066826</phone>
        <email>jennifer.stalder@dmschools.org</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Herbert Hoover High School</name>
        <address>
          <city>Des Moines</city>
          <state>Iowa</state>
          <zip>50310</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Stacie Nessa</last_name>
        <phone>515-788-1972</phone>
        <email>stacie.nessa@dmschools.org</email>
      </contact>
      <contact_backup>
        <last_name>Jenn Stalder</last_name>
        <phone>5153066826</phone>
        <email>jennifer.stalder@dmschools.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Barnert E, Iqbal Z, Bruce J, Anoshiravani A, Kolhatkar G, Greenbaum J. Commercial Sexual Exploitation and Sex Trafficking of Children and Adolescents: A Narrative Review. Acad Pediatr. 2017 Nov-Dec;17(8):825-829. doi: 10.1016/j.acap.2017.07.009. Epub 2017 Aug 7.</citation>
      <PMID>28797913</PMID>
    </reference>
    <reference>
      <citation>Prevention CfDCa. Rigorously Evaluating Programs and Policies to Prevent Child Sexual Abuse (CSA) RFA-CE-22-003. 2021</citation>
    </reference>
    <reference>
      <citation>Edwards JM, Iritani BJ, Hallfors DD. Prevalence and correlates of exchanging sex for drugs or money among adolescents in the United States. Sex Transm Infect. 2006 Oct;82(5):354-8. doi: 10.1136/sti.2006.020693. Epub 2006 Aug 10.</citation>
      <PMID>16901917</PMID>
    </reference>
    <reference>
      <citation>Miller-Perrin C, Wurtele SK. Sex trafficking and the commercial sexual exploitation of children. Women &amp; Therapy. 2017;40(1-2):123-151</citation>
    </reference>
    <reference>
      <citation>Anderson PM, Coyle KK, Johnson A, Denner J. An exploratory study of adolescent pimping relationships. J Prim Prev. 2014 Apr;35(2):113-7. doi: 10.1007/s10935-014-0338-3.</citation>
      <PMID>24445410</PMID>
    </reference>
    <reference>
      <citation>Estes RJ, Weiner NA. The commercial sexual exploitation of children in the US, Canada and Mexico. University of Pennsylvania, School of Social Work, Center for the Study of …; 2001</citation>
    </reference>
    <reference>
      <citation>Baird K, Connolly J. Recruitment and Entrapment Pathways of Minors into Sex Trafficking in Canada and the United States: A Systematic Review. Trauma Violence Abuse. 2023 Jan;24(1):189-202. doi: 10.1177/15248380211025241. Epub 2021 Jun 29.</citation>
      <PMID>34184579</PMID>
    </reference>
    <reference>
      <citation>Siller L, Edwards KM, Leader Charge D, Leader Charge L, Bordeaux S, Herrington R. An examination of bystander opportunity and behavior among adolescents on an Indian reservation. Cultur Divers Ethnic Minor Psychol. 2022 Apr;28(2):240-247. doi: 10.1037/cdp0000494. Epub 2021 Nov 11.</citation>
      <PMID>34766795</PMID>
    </reference>
    <reference>
      <citation>Turner HA, Finkelhor D, Hamby SL, Shattuck A, Ormrod RK. Specifying type and location of peer victimization in a national sample of children and youth. J Youth Adolesc. 2011 Aug;40(8):1052-67. doi: 10.1007/s10964-011-9639-5. Epub 2011 Mar 4.</citation>
      <PMID>21373905</PMID>
    </reference>
    <reference>
      <citation>Edwards KM, Rodenhizer-Stampfli KA, Eckstein RP. Bystander Action in Situations of Dating and Sexual Aggression: A Mixed Methodological Study of High School Youth. J Youth Adolesc. 2015 Dec;44(12):2321-36. doi: 10.1007/s10964-015-0307-z. Epub 2015 Jun 6.</citation>
      <PMID>26048529</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Human Trafficking</keyword>
    <keyword>Sex Trafficking</keyword>
    <keyword>Sex Crimes</keyword>
    <keyword>Commercial Sex</keyword>
    <keyword>Commercial Sexual Exploitation of Children</keyword>
    <keyword>Prevention</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The level of public access will be restricted such that the data set will be available under certain use restrictions. More specifically, the PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send the approved researcher the dataset prepared using SPSS 27.0 (or the latest version available). The prepared data set will not include identifying information about participants, schools, or DMPS. Research participants will be identified by number. Schools will be coded as a number so as not to identify the participating schools/district.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be made available likely around summer 2025. It will be made available indefinitely.</ipd_time_frame>
      <ipd_access_criteria>See above in Plan Description</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05988398
  org study id: 22811
  secondary id: 1U01CE003405-01
  nct id: NCT05988398
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The overall goal of the 5-year project is to conduct both a process and rigorous outcome
        evaluation of The Set Me Free Projects (SMFP) READY to Stand (RTS) curriculum with an eye
        toward widespread dissemination to other U.S. communities, if deemed effective.
  Detailed Description: The commercial sexual exploitation of children (CSEC) is a public
        health crisis in the U.S.1-4 Research has documented risk and protective factors across the
        social ecology for CSEC,2,5-8 that many perpetrators (traffickers, clients, recruiters) of
        CSEC are peers (e.g., romantic partners) 9-11 and adolescents report opportunities to
        intervene in situations of peer victimization (although not necessarily specific to
        CSEC).12-14 Prevention efforts with adolescents that seek to (1) reduce risk for CSEC
        perpetration; (2) reduce risk for CSEC victimization; and (3) increase positive bystander
        intervention in situations of CSEC is urgently needed. Thus, the goal of this
        multi-stakeholder collaboration-that includes researchers, educators, practitioners, and
        youth-is to conduct both a process and rigorous outcome evaluation of The Set Me Free
        Project's© (SMFP) READY to Stand (RTS)© curriculum-with an eye toward widespread
        dissemination to other U.S. communities, if deemed effective. This project is responsive to
        Research Priority Area 4 (preventing CSEC as a form of CSA) of RFA-CE-22-003. The
        implementation site includes eight high schools in Des Moines Public Schools (DMPS); students
        (naïve to the RTS curriculum) are largely racial/ethnic minority (65%) and low-income (76%).
        DMPS leadership have expressed a growing concern about the CSEC in their district and are
        eager to partner with researchers to rigorously evaluate the RTS curriculum. The RTS
        curriculum includes four, 45-minute modules implemented to high school students in mixed
        gender groups of ~25 students and provides students with psychoeducation on CSEC, healthy
        relationship skills training, identification of safe people/resources, and programming
        components to enhance valuing of self and others. As part of the proposed project, the RTS
        curriculum will be enhanced with two additional 45-minute modules on bystander intervention
        training in situations of CSEC and shifting school norms to be intolerant of all forms of
        violence, including CSEC. Additionally, school personnel participate in an enhanced (from 90
        minutes to 120 minutes) training to equip them with skills to effectively respond to
        students' disclosures of CSEC and to reinforce programming messages. The RTS curriculum may
        also reduce other forms of violence such as teen dating violence (TDV) given it addresses
        risk and protective factors for multiple forms of violence. Despite its potential for
        reducing CSEC, the RTS curriculum has never been evaluated. Specific Aims are as follows:
        Refinement and Planning Phase (Component A): Convene a Research Advisory Board (RAB) that
        includes researchers, practitioners, educators, caregivers, and youth who will provide input
        on all research components of the project (Aim 1a). Conduct focus groups with students (n=80)
        and school personnel (n=60) to inform the refinement of the RTS curriculum and research
        procedures for Component B (Aim 1b). Enhance the existing RTS program manual and create a
        training manual to ensure consistent implementation, produce training manuals for use in
        subsequent clinical trials and dissemination, and develop fidelity measures (Aim 1c). Develop
        via cognitive interviews (n=20 youth, n=10 school personnel) and surveys (n=878) with
        students valid, reliable, and developmentally appropriate measures of CSEC perpetration, CSEC
        victimization, and CSEC bystander opportunity/action to be used in subsequent research,
        including Component B (Aim 1d). Conduct an open pilot trial of the RTS curriculum in one of
        the five traditional high schools and one of the three alternative schools in DMPS with
        students (n=878) and school personnel (n=78) to gain experience with the recruitment and
        assessment procedures and administration of the intervention; assess acceptability and safety
        of the research protocols; document initial trends, effect sizes, and CSEC incidence rates;
        and refine the intervention and research procedures in preparation for Component B (Aim 1e).
        Apply for additional funding under Component B and disseminate findings to diverse audiences
        in collaboration with the RAB (Aim 1f). All procedures for Component B will be ready for
        implementation by the end of Component A funding. Rigorous Evaluation Phase (Component B):
        Conduct a quasi-experimental study in which four traditional high schools in DMPS and two
        alternative high schools (not including the two high schools that participated in Component
        A) are demographically matched and randomly assigned to treatment or wait-list control
        conditions. Students (n=7,241) will complete baseline and 6-, 12-, and 18-month follow-up
        surveys to test the hypothesis that participation in the RTS program will lead to reductions
        in CSEC perpetration (primary outcome), as well as reductions in CSEC victimization and TDV
        and sexual violence victimization and perpetration and increases in bystander intervention in
        CSEC situations compared to participants in the waitlist control condition (secondary
        outcomes) (Aim 2a). We will assess mediators and demographic moderators of program impact
        (Aim 2b). Document via program observations of student and school personnel programming (Aim
        2c), post-session surveys (n=7,241 students; n=396 school personnel) (Aim 2d), and
        post-program implementation key informant and stakeholder interviews (n=40: program
        facilitators [n=10], students [n=20], school personnel [n=10]) (Aim 2e) variations in
        implementation, unanticipated challenges, lessons learned, and perceptions of program impact.
        Determine costs associated with the program implementation (both student and school personnel
        programming) to inform future economic evaluation of the RTS curriculum (Aim 2f). Refine and
        assess validity and reliability of school personnel's' CSEC prevention related knowledge,
        attitudes, and skills (Aim 1g). Examine the preliminary impact of the RTS school personnel
        training curriculum on CSEC prevention related knowledge, attitudes, and skills as well as
        acceptability and perceptions of impact (Aim 1h).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Two Schools will receive the intervention in addition to pre- and post- surveys. There is no control group.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in CSEC Perpetration and Victimization (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Students' self-reports of experiencing CSEC perpetration and victimization.
  measure: Change in School Personnel's CSEC prevention related knowledge, attitudes, skills and cultural humility. (SCHOOL PERSONNEL)
  time frame: Baseline and 1 month post RTS delivery.
  description: Knowledge of Sex Trafficking Perpetration and Victimization, Sex Trafficking bystander Opportunity and action, Sex Trafficking Bystander Efficacy, CSEC Knowledge, Bystander Readiness to Help, Social Norms, Prevention related Conversations with School Personnel, Cultural humility, and Program acceptability, feasibility, and perceptions of impact and attitudes towards sustainability will be measured via pre-test (baseline) and post-test (1 month after RTS delivery).
  measure: Change in Bystander Intervention in situations of CSEC (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Students' self-reports of witnessing or experiencing CSEC perpetration and victimization as well as contextual and relational details for perpetration and victimization, and disclosure of CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour).
  measure: Change in Sexual Violence (SV) Perpetration and Victimization (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Students' self-reports of witnessing or hearing about topics relating to teen dating violence will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Dating Violence (MARSHA), Youth Violence (YRBS), Attitudes Towards Dating Violence (Acceptance of Couples Violence Scale), Green Dot and Bringing in the Bystander (BTIB).
  measure: Change in Teen Dating Violence (TDV) Perpetration and Victimization (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Students' self-reports of witnessing or hearing about topics relating to CSEC, sex trafficking, sexual harassment, stalking, and dating violence and what their follow-up actions were, if any, will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Dating Violence (MARSHA), Youth Violence (YRBS), Attitudes Towards Dating Violence (Acceptance of Couples Violence Scale).
  measure: Change in Knowledge of CSEC (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Commercial Sexual Exploitation of Children - Youth Self Report Survey (CSEC-YSRS), youth's knowledge of rates, causes, and outcomes of CSEC, and recognizing what constitutes as CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour).
  measure: Change in Valuing Self and Others (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Students perceived self-worth and values, deserving to be treated with respect, Sexual and reproductive empowerment, Attitudes towards dating violence and acceptability of couple violence will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from measures and conceptualizations of PYD and dignity, Empowerment (Sexual and reproductive empowerment scale for adolescents and young adults), Developmental Assets Scale, Positive Identity subscales, Social Competencies subscales.
  measure: Change in Healthy Relationship Skills (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Recognizing what are respectful, non-abusive and non-exploitative relationships as well as behavioral signs that don't constitute a health relationship will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Communication Skills Test, Sexual Communication Self-Efficacy Scale, Social-Emotional Competence Questionnaire (SECQ), and Relationship Management subscale.
  measure: Change in Prevention-related Communication with School Personnel (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Conversations with school personnels about health relationships, valuing self and others, healthy relationship skills, CSEC, dating violence, and/or bystander interventions will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from BITB and Youth VIP study.
  measure: Change in Bystander Readiness to Help in Situations of CSEC (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Understanding of safe and effective interventions in situations of CSEC, and ability to recognize and intervene to prevent CSEC and deter youths in situations of CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Readiness to Help Scale (D-RHS), and Denial subscale.
  measure: Change in Perceptions of Social Norms of Prevention of CSEC (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Understanding of safe and effective interventions in situations of CSEC, and ability to recognize and intervene to prevent CSEC and deter youths in situations of CSEC will be measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Readiness to Help Scale (D-RHS), and Denial subscale.
  measure: Control Variables (STUDENTS)
  time frame: Baseline and 1 month post RTS delivery.
  description: Moderators and mediators will be assessed and measured via pre-test (baseline) and post-test (1 month after RTS delivery). Each pre- and post-test survey will take 30 minutes to complete (total of 1 hour). Questions were adapted from Comprehensive Measure of Adverse Childhood Experience-Child Self-Report Version, Homelessness (CDC YRBS), Family Involvement in Sex Trade, Depression (PHQ-9), Alcohol use, Life Experiences Survey (System Involvement), and Academic and Career Commitment.
  arm group label: RTS Intervention
  arm group type: Experimental
  description: RTS intervention will include a total of one 120-minute session of programming delivered to school personnel, and six, 45-minute sessions (total = 4.5 hours) for students. There are five components in this intervention that both students and school personnels will receive: 1) Psychoeducation on CSEC, 2) Healthy relationship skills training, 3) Programming components to enhance valuing of self and others, 4) Bystander intervention skills, and 5) Social norms for both students and school personnel. Students will additionally receive programming on Identification of safe people and resources, while school personnel will receive programming on Responding to Student Disclosures, and Cultural Humility.
  intervention type: Behavioral
  intervention name: READY To Stand Curriculum
  description: Students will receive the RTS programming over six consecutive school days, spread over two weeks. The program is delivered in mixed-gender groups of 20 to 40 students and includes videos, small and large group discussions, activities, worksheets, and ample opportunities for skill-building. This curriculum is intended to be one piece of comprehensive prevention strategies that has the potential to make immediate and sustained impacts on reducing rates of CSEC perpetration in the lives of youth, including those most vulnerable to this pernicious crime.
  arm group label: RTS Intervention
  other name: RTS
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Katie M Edwards, PhD
  role: Principal Investigator
  affiliation: University of Nebraska Lincoln
  last name: Rochelle Dalla, PhD
  role: Study Director
  affiliation: University of Nebraska Lincoln
  last name: Lorey Wheeler, PhD
  role: Study Director
  affiliation: University of Nebraska Lincoln
  last name: Aleesa K Nutting, MA
  phone: 5154106536
  email: anutting2@unl.edu
  last name: Katie M Edwards, PhD
  phone: 603-422-3207
  email: katie.edwards@unl.edu
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  country: United States
  citation: Barnert E, Iqbal Z, Bruce J, Anoshiravani A, Kolhatkar G, Greenbaum J. Commercial Sexual Exploitation and Sex Trafficking of Children and Adolescents: A Narrative Review. Acad Pediatr. 2017 Nov-Dec;17(8):825-829. doi: 10.1016/j.acap.2017.07.009. Epub 2017 Aug 7.
  PMID: 28797913
  citation: Prevention CfDCa. Rigorously Evaluating Programs and Policies to Prevent Child Sexual Abuse (CSA) RFA-CE-22-003. 2021
  citation: Edwards JM, Iritani BJ, Hallfors DD. Prevalence and correlates of exchanging sex for drugs or money among adolescents in the United States. Sex Transm Infect. 2006 Oct;82(5):354-8. doi: 10.1136/sti.2006.020693. Epub 2006 Aug 10.
  PMID: 16901917
  citation: Miller-Perrin C, Wurtele SK. Sex trafficking and the commercial sexual exploitation of children. Women & Therapy. 2017;40(1-2):123-151
  citation: Anderson PM, Coyle KK, Johnson A, Denner J. An exploratory study of adolescent pimping relationships. J Prim Prev. 2014 Apr;35(2):113-7. doi: 10.1007/s10935-014-0338-3.
  PMID: 24445410
  citation: Estes RJ, Weiner NA. The commercial sexual exploitation of children in the US, Canada and Mexico. University of Pennsylvania, School of Social Work, Center for the Study of …; 2001
  citation: Baird K, Connolly J. Recruitment and Entrapment Pathways of Minors into Sex Trafficking in Canada and the United States: A Systematic Review. Trauma Violence Abuse. 2023 Jan;24(1):189-202. doi: 10.1177/15248380211025241. Epub 2021 Jun 29.
  PMID: 34184579
  citation: Siller L, Edwards KM, Leader Charge D, Leader Charge L, Bordeaux S, Herrington R. An examination of bystander opportunity and behavior among adolescents on an Indian reservation. Cultur Divers Ethnic Minor Psychol. 2022 Apr;28(2):240-247. doi: 10.1037/cdp0000494. Epub 2021 Nov 11.
  PMID: 34766795
  citation: Turner HA, Finkelhor D, Hamby SL, Shattuck A, Ormrod RK. Specifying type and location of peer victimization in a national sample of children and youth. J Youth Adolesc. 2011 Aug;40(8):1052-67. doi: 10.1007/s10964-011-9639-5. Epub 2011 Mar 4.
  PMID: 21373905
  citation: Edwards KM, Rodenhizer-Stampfli KA, Eckstein RP. Bystander Action in Situations of Dating and Sexual Aggression: A Mixed Methodological Study of High School Youth. J Youth Adolesc. 2015 Dec;44(12):2321-36. doi: 10.1007/s10964-015-0307-z. Epub 2015 Jun 6.
  PMID: 26048529
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: The level of public access will be restricted such that the data set will be available under certain use restrictions. More specifically, the PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send the approved researcher the dataset prepared using SPSS 27.0 (or the latest version available). The prepared data set will not include identifying information about participants, schools, or DMPS. Research participants will be identified by number. Schools will be coded as a number so as not to identify the participating schools/district.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data will be made available likely around summer 2025. It will be made available indefinitely.
  ipd access criteria: See above in Plan Description