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Sex TraffickingProject LIVENCT06587529

Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children

A study testing The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum in people with Sex Trafficking and Sex Crimes, run by University of Michigan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The overall goal of this project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project (SMFP)'s 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 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Sex Trafficking, Sex Crimes, Commercial Sex
What is being tested?
The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
8 Jul 2024to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • are ages 13-19; (2) reside in the greater Des Moines/Polk County community; and (3) are able to understand spoken English.

Who cannot join

  • enrolled in either of the two schools involved in the corresponding Open Pilot Trial (NCT05988398)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katie M Edwards, Ph.D. contact

515-410-6536

edkatie@umich.edu

Rochelle M Dalla, PhD contact

515-410-6536

rdalla1@unl.edu

United States1 site, 1 recruiting

  • School/community center

    Des Moines, Iowa, 50309

    Katie Edwards, Ph.D., 734-647-8812, edkatie@umich.edu

    Recruiting

Other trials in United States

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 III: Quasi Experimental Trial)

The overall goal of this project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project (SMFP)'s READY to Stand (RTS)© curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective. Broadly, the investigators seek to determine the effect participation has on students: reductions in commercial sexual exploitation of children (CSEC) perpetration (the primary outcome); reductions in CSEC victimization, teen dating violence (TDV), and sexual violence victimization and perpetration; as well as increases in bystander intervention in CSEC situations compared to participants in the control condition (secondary outcomes). Process evaluation components include fidelity monitoring, post session surveys, and exit interviews. The methodology includes a community-based RCT in which youth (N=400-600) are randomly assigned to the treatment (RTS) or attention control condition (nutrition program).

Read the detailed description

The commercial sexual exploitation of children (CSEC) is a public health crisis in the United States. Research has documented risk and protective factors across the social ecology for CSEC, that many perpetrators (traffickers, clients, recruiters) of CSEC are peers (e.g., romantic partners) and adolescents report opportunities to intervene in situations of peer victimization (although not necessarily specific to CSEC). 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-which includes researchers, educators, practitioners, and youth-is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project© (SMFP)'s READY to Stand (RTS)© curriculum-with an eye toward widespread dissemination to other U.S. communities, if deemed effective.

The RTS programming is for teens. The teen programming includes six, 45-minute modules implemented in a community-based model. Each cohort will be mixed gender groups of 50 students teens and provides students them with CSEC psychoeducation, healthy relationship skills, identification of safe people, bystander intervention in CSEC situations, shifting school norms to be intolerant of all forms of violence, and valuing of self and others. Despite its potential for reducing CSEC, the RTS© has never been evaluated.

The investigators will conduct an community-based RCT study in which enrolled youth (N=400-600)will be randomly assigned to the RTS condition or an attention control condition (nutrition program). Youth will complete baseline and immediate post, 6- and 12-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 teen dating violence (TDV) and sexual violence victimization and perpetration, and increases in bystander intervention in CSEC situations compared to participants in the control condition (secondary outcomes). The investigators will assess mediators and demographic moderators of program impact. Document via program observations of programming, post-session surveys, and post program implementation of key informant and stakeholder interviews, 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.

Being tested
The Set Me Free Project's (SMFP) READY to Stand (RTS)© 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.

  • The Set Me Free Project's (SMFP) READY to Stand (RTS)© CurriculumBehavioural

    Also called RTS©

    Teens will receive six modules of the Ready to Stand (RTS)© programming over one day on a weekend. There will be four cohorts over two weekends. The program is delivered in mixed-gender groups of 30-50 teens 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 groups in NCT06587529
Study groupRoleWhat they receive
TreatmentExperimentalREADY to Stand© curriculum
Receives: Behavioral: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum
ControlActive comparatorNutritional workshop delivered by a dietician
Receives: Behavioral: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Commercial Sexual Exploitation of Children (CSEC)-Perpetration Experiences

    Behaviorally worded items to assess students' self-reports of commercial sexual exploitation of children (CSEC) victimization perpetration; answers are binary (Yes/No) with an option not to answer. Scale information: items are summed and used to create two variables, one indicating if a student has ever experienced these activities and the other indicating if a student has experienced these activities in the past 1 or 6 months (1-month time frame utilized at baseline, 6-month time frame utilized for all follow ups). Higher scores indicate worse outcomes.

    Measured: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)

Secondary outcomes (4)

  1. Commercial Sexual Exploitation of Children (CSEC)-Bystander Opportunity and Action

    Response options range from 0 to "10 or more" with an option to not answer. If participants report "one or more times" they are then asked how many times they took the specified actions. Eleven actions are listed, two of which are negative behaviors, such as doing nothing, with the other nine actions being positive behaviors, such as trying to stop the situation. For each positive action, students' responses are re-coded into a binary variable where 0=did not take action and 1=did take action. For each negative item, responses are reverse-scored. Items are then summed to create an overall score that could range from 2 to 7, with a higher score indicating better outcomes.

    Measured: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)

  2. Commercial Sexual Exploitation of Children (CSEC)-Victimization Experiences

    Behaviorally worded items to assess students' self-reports of commercial sexual exploitation of children (CSEC) victimization; answers are binary (Yes/No) with an option not to answer. Scale information: items are summed and used to create two variables, one indicating if a student has ever experienced these activities and the other indicating if a student has experienced these activities in the past month. Higher scores indicate worse outcomes.

    Measured: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)

  3. Dating and Sexual Violence Victimization

    Dating and sexual violence victimization will be assessed using items adapted from the Youth Risk Behavior Survey (YRBS) and the Measure of Adolescent Relationship Harassment and Abuse (MARSHA). Items assess sexual violence, physical dating violence, psychological dating violence, and controlling behavior. Participants report the frequency of each experience during the specified assessment period, with higher scores indicating greater frequency of victimization.

    Measured: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)

  4. Dating and Sexual Violence Perpetration

    Dating and sexual violence perpetration will be assessed using items adapted from the Youth Risk Behavior Survey (YRBS) and the Measure of Adolescent Relationship Harassment and Abuse (MARSHA). Items assess sexual violence, physical dating violence, psychological dating violence, and controlling behavior. Participants report the frequency of each behavior during the specified assessment period, with higher scores indicating greater frequency of perpetration.

    Measured: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start8 Jul 2024
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587529
Sponsor's protocol ID
00263719
Acronym
Project LIVE
Status last verified
Oct 2026
First submitted
29 Jul 2024
Last updated
13 Oct 2026
Results posted
No
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 Des Moines Public Schools. Research participants will be identified by number. Schools will be coded as a number so as not to identify the participating schools/district.

Publications

  • Edwards 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 35303249

  • 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 25255794

  • Lipson, J. (2001). Hostile hallways: Bullying, teasing, and sexual harassment in school. AAUW Educational Foundation, 1111 Sixteenth Street, NW, Washington, DC 20036.

  • Rothman EF, Paruk J, Cuevas CA, Temple JR, Gonzales K. The Development of the Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Input From Black and Multiracial, Latinx, Native American, and LGBTQ+ Youth. J Interpers Violence. 2022 Mar;37(5-6):2126-2149. doi: 10.1177/0886260520936367. Epub 2020 Jul 5.

    PubMed 32627640

  • Centers 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

  • 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

  • Monitoring the future national survey results on drug use, 1975-2020: Overview, key findings on adolescent drug use. https://eric.ed.gov/?id=ED611736.

  • Hulsey L., Zief, S., & Murphy, L. PREP Entry and Exit Survey Measures Guide. 2022. https://www.prepeval.com/DataCollection/50273%20Data%20Dictionary%202022.pdf

  • Project SMF. READY to Stand Curriculum. 2021

  • Ziebertz H-G, Döhnert S, Unser A. Predictors of attitudes towards human dignity: An empirical analysis among youth in Germany. Religion and civil human rights in empirical perspective. Springer; 2018:17-60.

  • Lebech M. What is human dignity? Maynooth philosophical papers. 2004;2:59-69.

  • 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 20397040

  • Park, N. (2004). Character strengths and positive youth development. The Annals of the American Academy of Political and Social Science, 591(1), 40-54.

  • Lerner, R. M., Almerigi, J. B., Theokas, C., & Lerner, J. V. (2005). Positive youth development a view of the issues. The journal of early adolescence, 25(1), 10-16.

Questions about this trial

What is this clinical trial studying?

A study testing The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum in people with Sex Trafficking and Sex Crimes, run by University of Michigan 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katie M Edwards, Ph.D. (515-410-6536, edkatie@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Commercial Sexual Exploitation of Children (CSEC)-Perpetration Experiences (time frame: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)). 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 NCT06587529, which also lists 26 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 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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