Sex TraffickingProject LIVENCT05988398
Preventing Commercial Sexual Exploitation of Children
A study testing READY To Stand Curriculum in people with Sex Trafficking and Sex Crimes, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sex Trafficking, Sex Crimes, Commercial Sex
- What is being tested?
- READY To Stand Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 29 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For school personnel, participants must be 18 years of age or older and currently employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS for the survey development portion of the study (Aim 1g). We will include anyone working in administration (e.g., principal), teaching (e.g., academic subject matter instructor) or support service (e.g., counselor) capacity within any of the eight high schools encompassed within Des Moines Public School (DMPS) system.
- For students, participants must be in Grades 9 through 12 at one of the eight participating high schools in DMPS and be able to understand spoken English. For the OPT (Aims 1e, 1h) this includes Hoover and All Points.
Who cannot join
- For school personnel, not being 18 or older or currently employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS.
- For students, being in Grades younger than 9 or older than 12 and not being enrolled in participating high school in DMPS.
Trial locations and contacts
1 site in 1 country.
United States1 site
[a school district in the Midwest]
Des Moines, Iowa, 50047
About this study
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)
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.
Read the detailed description
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).
- Conditions
- Sex Trafficking, Sex Crimes, Commercial Sex, Sexual Violence, Child Abuse, Sexual, Sex Offense
- Being tested
- READY To Stand Curriculum
- Keywords
- Human Trafficking, Sex Trafficking, Sex Crimes, Commercial Sex, Commercial Sexual Exploitation of Children, Prevention
- Medical subject headings
- Sex Work, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
READY To Stand CurriculumBehavioural
Also called RTS
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.
| Study group | Role | What they receive |
|---|---|---|
| RTS Intervention | Experimental | 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. Receives: Behavioral: READY To Stand Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Commercial Sexual Exploitation Children (CSEC) Perpetration (STUDENT Reported)
For the initial pool of items, we identified existing CSEC perpetration items from The National Study on Adolescent to Adult Health (ADD Health; Franchino-Olsen et al., 2021) and The My Life My Choices evaluation study (Rothman et al., 2021). The scale consists of 21 statements and response options included yes, no, or I do not want to answer this question. A total score is calculated from the sum of the items, with higher scores reflective of a higher sex trafficking perpetration experiences in the past month.
Measured: 1-month post RTS delivery
Secondary outcomes (13)
Commercial Sexual Exploitation of Children (CSEC) Victimization (STUDENT Reported)
For the initial pool of items, we identified existing CSEC victimization items from The National Study on Adolescent to Adult Health (ADD Health; Franchino-Olsen et al., 2021) and The My Life My Choices evaluation study (Rothman et al., 2021). The scale consists of 21 statements and response options included yes, no, or I do not want to answer this question. A total score is calculated from the sum of the items, with higher scores reflective of a higher sex trafficking victimization experiences in the past month.
Measured: One-month post RTS delivery
Bystander Readiness to Help (STUDENT Reported)
The bystander readiness to help scale was based on the denial subscale of the readiness to help scale (D-RHS; Banyard et al., 2014) to assess students's awareness of and willingness to engage in prevention efforts regarding CSE among high school students in their school district. These items have similarly been adapted for measuring opinions regarding relationship abuse and/or sexual assault among high school students (Edwards et al., 2018). The scale consists of four statements using a 4-point Likert scale (1 = strongly agree to 4 = strongly disagree). A total score is calculated from the average of the items, with higher scores reflective of a greater sense of need and the willingness to engage.
Measured: One-month post RTS delivery
Sexual Assault Victimization (STUDENT Reported)
Behaviorally worded items to assess students' self-reports of experiencing past month sexual assault victimization, with items adapted from Cook-Craig et al. (2014). The scale consists of 4 items with response options (1=Yes, 0=No, and -999=I don't want to answer). The original scale has response options ranging from 0-4 (0=0 times, 4=10+ times). A total score is calculated from taking a count of items with a response of "yes", with scores ranging from 0-4. Higher scores indicate more instances of sexual assault victimization having occurred.
Measured: 1-month post RTS delivery
Sexual Assault Perpetration (STUDENT Reported)
Behaviorally worded items to assess students' self-reports of experiencing past month sexual assault perpetration, with items adapted from Cook-Craig et al. (2014). The scale consists of 4 items with response options (1=Yes, 0=No, and -999=I don't want to answer). The original scale has response options ranging from 0-4 (0=0 times, 4=10+ times). A total score is calculated from taking a count of items with a response of "yes", with scores ranging from 0-4. Higher scores indicate more instances of sexual assault perpetration having occurred.
Measured: One-month post RTS delivery
Sexual Harassment Victimization (STUDENT Reported)
Behaviorally worded items to assess past month students' self-reports of experiencing sexual harassment victimization. Items adapted from American Association of University Women Educational Foundation (2001, p.21). The scale consists of 2 items with response options (1=Yes, 0=No, and -999=I don't want to answer). A total score is calculated from taking a count of items with a response of "yes", with scores ranging from 0-2. Higher scores indicate more instances of sexual harrassment victimization having occurred.
Measured: 1-month post RTS delivery
Sexual Harassment Perpetration (STUDENT Reported)
Behaviorally worded items to assess past month students' self-reports of experiencing sexual harassment perpetration. Items adapted from American Association of University Women Educational Foundation (2001, p.21). The scale consists of 2 items with response options (1=Yes, 0=No, and -999=I don't want to answer). A total score is calculated from taking a count of items with a response of "yes", with scores ranging from 0-2. Higher scores indicate more instances of sexual harrassment perpetration having occurred.
Measured: 1-month post RTS delivery
Stalking Victimization (STUDENT Reported)
Behaviorally worded items to assess students' past month self-reports of experiencing stalking victimization, with items adapted from(Cook-Craig et al. 2014). The scale consists of 3 items with response options (1=Yes, 0=No, and -999=I don't want to answer). The original scale has response options ranging from 0-4 (0=0 times, 4=10+ times). A total score is calculated from taking a count of items with a response of "yes", with scores ranging from 0-3. Higher scores indicate more instances of stalking victimization having occurred.
Measured: 1-month post RTS delivery
Stalking Perpetration (STUDENT Reported)
Behaviorally worded items to assess students' past month self-reports of experiencing stalking perpetration, with items adapted from(Cook-Craig et al. 2014). The scale consists of 3 items with response options (1=Yes, 0=No, and -999=I don't want to answer). The original scale has response options ranging from 0-4 (0=0 times, 4=10+ times). A total score is calculated from taking a count of items with a response of "yes", with scores ranging from 0-3. Higher scores indicate more instances of stalking perpetration having occurred.
Measured: 1-month post RTS delivery
Dating Violence Victimization (STUDENT Reported)
The Measure of Adolescent Relationship Harassment and Abuse (MARSHA; Rothman et al. 2020) was used to assess past month dating violence victimization. The scale consists of two subscales, Physical abuse (7 items) and Isolation (3 items), with response options of 1=Yes, 0=No, and -999=I don't want to answer. A total score is calculated from the counting the nunber of items answers as "yes". Higher scores indicate more instances of dating violence victimization having occurred.
Measured: 1-month post RTS delivery
Dating Violence Perpetration (STUDENT Reported)
The Measure of Adolescent Relationship Harassment and Abuse (MARSHA; Rothman et al. 2020) was used to assess past month dating violence perpetration. The scale consists of two subscales, Physical abuse (7 items) and Isolation (3 items), with response options of 1=Yes, 0=No, and -999=I don't want to answer. A total score is calculated from the counting the nunber of items answers as "yes". Higher scores indicate more instances of dating violence perpetration having occurred.
Measured: 1-month post RTS delivery
Youth Violence (STUDENT Reported)
The Youth Risk Behavior Surveillance System (YRBS; Centers for Disease Control and Prevention, 2019) was used to measure past month physical fights, fear of going to school, and weapon carrying. The scale consisted of 4 items with response options of 1=Yes, 0=No, and -999=I don't want to answer. A total score is calculated from the counting the nunber of items answers as "yes". Higher scores indicate more instances of youth violence having occurred.
Measured: 1-month post RTS delivery
Depression (STUDENT Reported)
The Patient Health Questionnaire (PHQ-9) modified (Johnson et al. 2002) was used to measure past two week depression. The scale consisted of 8 items with response options from Not at all (0) to Nearly every day (3) and I don't want to answer (-999). The toal score is calculated from the average of the items, with higher scores representing higher depression symptoms.
Measured: 1-month post RTS delivery
Academic & Career Commitment (STUDENT Reported)
Items from Hulsey et al. (2022) were used to measures students intentions on graduating high school/getting a GED as well as having a job/career. The scale consisted of 5 items with response scales from Not at all true of me (1) to Extremely true of me (4) and I don't want to answer this question (-999). The total scores were calculated from the average of the items, with higher scores representing higher academic and career commitment.
Measured: 1-month post RTS delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Sex TraffickingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two Schools will receive the intervention in addition to pre- and post- surveys. There is no control group.
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- The Set Me Free Project, Des Moines Public Schools, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Katie M Edwards, PhD, Principal investigator, University of Nebraska LincolnRochelle Dalla, PhD, Study director, University of Nebraska LincolnLorey Wheeler, PhD, Study director, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988398
- Sponsor's protocol ID
- 22811
- Other IDs
- 1U01CE003405
- Acronym
- Project LIVE
- Status last verified
- May 2025
- First submitted
- 4 Aug 2023
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Prevention CfDCa. Rigorously Evaluating Programs and Policies to Prevent Child Sexual Abuse (CSA) RFA-CE-22-003. 2021
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.
PubMed 24445410American Association of University Women Educational Foundation. Hostile hallways: Bullying, teasing, and sexual harassment in school. ERIC; 2001.
Bal M. A Review of Human Dignity. Dignity in the Workplace. 2017:41-66.
Bowers EP, Li Y, Kiely MK, Brittian A, Lerner JV, Lerner RM. The Five Cs model of positive youth development: a longitudinal analysis of confirmatory factor structure and measurement invariance. J Youth Adolesc. 2010 Jul;39(7):720-35. doi: 10.1007/s10964-010-9530-9. Epub 2010 Apr 16.
PubMed 20397040Centers for Disease Control and Prevention. 2019 Youth Risk Behavior Surveillance System results. U.S. Department of Health & Human Services. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm
Cook-Craig PG, Coker AL, Clear ER, Garcia LS, Bush HM, Brancato CJ, Williams CM, Fisher BS. Challenge and opportunity in evaluating a diffusion-based active bystanding prevention program: Green Dot in high schools. Violence Against Women. 2014 Oct;20(10):1179-202. doi: 10.1177/1077801214551288. Epub 2014 Sep 24.
PubMed 25255794Edwards KM, Banyard VL, Kirkner A. Parents Matter: A Descriptive Study of Parental Discussions With Teens About Violence Prevention and Related Topics. J Interpers Violence. 2022 Apr;37(7-8):NP3856-NP3874. doi: 10.1177/0886260520949153. Epub 2020 Aug 26.
PubMed 32842824Edwards KM, Banyard VL, Waterman EA, Mitchell KJ, Jones LM, Kollar LMM, Hopfauf S, Simon B. Evaluating the Impact of a Youth-Led Sexual Violence Prevention Program: Youth Leadership Retreat Outcomes. Prev Sci. 2022 Nov;23(8):1379-1393. doi: 10.1007/s11121-022-01343-x. Epub 2022 Mar 18.
PubMed 35303249Edwards KM, Littleton H. Development and pilot evaluation of an online intervention to prevent dating violence and problem drinking in sexual minority youth. University of Nebraska Lincoln, Lincoln, NE: National Institute of Health; 2021-2023.
Edwards KM, Sessarego SN, Stanley LR, Mitchell KJ, Eckstein RP, Rodenhizer KAE, Leyva PC, Banyard VL. Development and Psychometrics of Instruments to Assess School Personnel's Bystander Action in Situations of Teen Relationship Abuse and Sexual Assault. J Interpers Violence. 2021 Feb;36(3-4):NP1586-1606NP. doi: 10.1177/0886260517746946. Epub 2017 Dec 20.
PubMed 29295034Franchino-Olsen H, Martin SL, Halpern CT, Preisser JS, Zimmer C, Shanahan M. Adolescent Experiences of Violence Victimizations Among Minors Who Exchange Sex/Experience Minor Sex Trafficking. J Interpers Violence. 2022 Sep;37(17-18):NP16277-NP16301. doi: 10.1177/08862605211021967. Epub 2021 Jun 30.
PubMed 34192962Hulsey L, Zief, S., & Murphy, L. PREP Entry and Exit Survey Measures Guide. 2022. https://www.prepeval.com/DataCollection/50273%20Data%20Dictionary%202022.pdf
Jenkins N, Saiz C. The communication skills test. Unpublished manuscript, University of Denver, Denver, CO. 1995
Johnson JG, Harris ES, Spitzer RL, Williams JB. The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002 Mar;30(3):196-204. doi: 10.1016/s1054-139x(01)00333-0.
PubMed 11869927
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05988398
- Acronym / sponsor ID
- Project LIVE / 22811
- Conditions
- Sex Trafficking, Sex Crimes, Commercial Sex, Sexual Violence, Child Abuse, Sexual, Sex Offense
- Keywords
- Human Trafficking, Sex Trafficking, Sex Crimes, Commercial Sex, Commercial Sexual Exploitation of Children, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- The Set Me Free Project, Des Moines Public Schools, Centers for Disease Control and Prevention
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two Schools will receive the intervention in addition to pre- and post- surveys. There is no control group.
| Arm | Type | Receives |
|---|---|---|
| RTS Intervention | Experimental | Behavioral: READY To Stand CurriculumRTS 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. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- For school personnel, participants must be 18 years of age or older and currently employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS for the survey development portion of the study (Aim 1g). We will include anyone working in administration (e.g., principal), teaching (e.g., academic subject matter instructor) or support service (e.g., counselor) capacity within any of the eight high schools encompassed within Des Moines Public School (DMPS) system.
- For students, participants must be in Grades 9 through 12 at one of the eight participating high schools in DMPS and be able to understand spoken English. For the OPT (Aims 1e, 1h) this includes Hoover and All Points.
Key exclusion criteria (2 listed)
- For school personnel, not being 18 or older or currently employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS.
- For students, being in Grades younger than 9 or older than 12 and not being enrolled in participating high school in DMPS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| READY To Stand CurriculumAlso: RTSStudents 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. | Behavioural | RTS Intervention |
Primary outcome
Commercial Sexual Exploitation Children (CSEC) Perpetration (STUDENT Reported)
Time frame: 1-month post RTS delivery
For the initial pool of items, we identified existing CSEC perpetration items from The National Study on Adolescent to Adult Health (ADD Health; Franchino-Olsen et al., 2021) and The My Life My Choices evaluation study (Rothman et al., 2021). The scale consists of 21 statements and response options included yes, no, or I do not want to answer this question. A total score is calculated from the sum of the items, with higher scores reflective of a higher sex trafficking perpetration experiences in the past month.
13 secondary outcomes
Commercial Sexual Exploitation of Children (CSEC) Victimization (STUDENT Reported)
Time frame: One-month post RTS delivery
Bystander Readiness to Help (STUDENT Reported)
Time frame: One-month post RTS delivery
Sexual Assault Victimization (STUDENT Reported)
Time frame: 1-month post RTS delivery
Sexual Assault Perpetration (STUDENT Reported)
Time frame: One-month post RTS delivery
Sexual Harassment Victimization (STUDENT Reported)
Time frame: 1-month post RTS delivery
Sexual Harassment Perpetration (STUDENT Reported)
Time frame: 1-month post RTS delivery
Stalking Victimization (STUDENT Reported)
Time frame: 1-month post RTS delivery
Stalking Perpetration (STUDENT Reported)
Time frame: 1-month post RTS delivery
Dating Violence Victimization (STUDENT Reported)
Time frame: 1-month post RTS delivery
Dating Violence Perpetration (STUDENT Reported)
Time frame: 1-month post RTS delivery
Youth Violence (STUDENT Reported)
Time frame: 1-month post RTS delivery
Depression (STUDENT Reported)
Time frame: 1-month post RTS delivery
Academic & Career Commitment (STUDENT Reported)
Time frame: 1-month post RTS delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundPrevention CfDCa. Rigorously Evaluating Programs and Policies to Prevent Child Sexual Abuse (CSA) RFA-CE-22-003. 2021
- Background: PubMed 24445410Anderson 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.
- BackgroundAmerican Association of University Women Educational Foundation. Hostile hallways: Bullying, teasing, and sexual harassment in school. ERIC; 2001.
- BackgroundBal M. A Review of Human Dignity. Dignity in the Workplace. 2017:41-66.
- Background: PubMed 20397040Bowers EP, Li Y, Kiely MK, Brittian A, Lerner JV, Lerner RM. The Five Cs model of positive youth development: a longitudinal analysis of confirmatory factor structure and measurement invariance. J Youth Adolesc. 2010 Jul;39(7):720-35. doi: 10.1007/s10964-010-9530-9. Epub 2010 Apr 16.
- BackgroundCenters for Disease Control and Prevention. 2019 Youth Risk Behavior Surveillance System results. U.S. Department of Health & Human Services. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm
- Background: PubMed 25255794Cook-Craig PG, Coker AL, Clear ER, Garcia LS, Bush HM, Brancato CJ, Williams CM, Fisher BS. Challenge and opportunity in evaluating a diffusion-based active bystanding prevention program: Green Dot in high schools. Violence Against Women. 2014 Oct;20(10):1179-202. doi: 10.1177/1077801214551288. Epub 2014 Sep 24.
- Background: PubMed 32842824Edwards KM, Banyard VL, Kirkner A. Parents Matter: A Descriptive Study of Parental Discussions With Teens About Violence Prevention and Related Topics. J Interpers Violence. 2022 Apr;37(7-8):NP3856-NP3874. doi: 10.1177/0886260520949153. Epub 2020 Aug 26.
- Background: PubMed 35303249Edwards KM, Banyard VL, Waterman EA, Mitchell KJ, Jones LM, Kollar LMM, Hopfauf S, Simon B. Evaluating the Impact of a Youth-Led Sexual Violence Prevention Program: Youth Leadership Retreat Outcomes. Prev Sci. 2022 Nov;23(8):1379-1393. doi: 10.1007/s11121-022-01343-x. Epub 2022 Mar 18.
- BackgroundEdwards KM, Littleton H. Development and pilot evaluation of an online intervention to prevent dating violence and problem drinking in sexual minority youth. University of Nebraska Lincoln, Lincoln, NE: National Institute of Health; 2021-2023.
- Background: PubMed 29295034Edwards KM, Sessarego SN, Stanley LR, Mitchell KJ, Eckstein RP, Rodenhizer KAE, Leyva PC, Banyard VL. Development and Psychometrics of Instruments to Assess School Personnel's Bystander Action in Situations of Teen Relationship Abuse and Sexual Assault. J Interpers Violence. 2021 Feb;36(3-4):NP1586-1606NP. doi: 10.1177/0886260517746946. Epub 2017 Dec 20.
- Background: PubMed 34192962Franchino-Olsen H, Martin SL, Halpern CT, Preisser JS, Zimmer C, Shanahan M. Adolescent Experiences of Violence Victimizations Among Minors Who Exchange Sex/Experience Minor Sex Trafficking. J Interpers Violence. 2022 Sep;37(17-18):NP16277-NP16301. doi: 10.1177/08862605211021967. Epub 2021 Jun 30.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie M Edwards, PhD principal investigator
University of Nebraska Lincoln
Rochelle Dalla, PhD study director
University of Nebraska Lincoln
Lorey Wheeler, PhD study director
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing READY To Stand Curriculum in people with Sex Trafficking and Sex Crimes, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Commercial Sexual Exploitation Children (CSEC) Perpetration (STUDENT Reported) (time frame: 1-month post RTS delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05988398, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.