ClinicalTrials.gg
RecruitingNCT06587529Project LIVEUpdated Oct 13, 2026

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

An interventional study of The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum in Sex Trafficking, Sex Crimes and Commercial Sex, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by University of Michigan · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Updated Oct 13, 2026Primary outcomes revisedEnrollment updated+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
13 Years to 19 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 7, 2026. See what changed

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • enrolled in either of the two schools involved in the corresponding Open Pilot Trial (NCT05988398)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Treatment

    READY to Stand© curriculum

    Behavioral: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum

  • Active comparator
    Control

    Nutritional workshop delivered by a dietician

    Behavioral: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum

Interventions

  • BehavioralThe Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum

    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.

    Also known as: RTS©

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Other outcomes

  1. Commercial Sexual Exploitation of Children (CSEC) Knowledge

    Researcher created items to assess knowledge about sex trafficking (that aligns with the student programming being received). This measure is comprised of 19 items across four subscales. For each subscale, a total score is calculated by taking the mean of the items. The mean is the proportion of items answered correctly; scores can range from 0-1, with a higher score indicating better outcomes.

    Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)

  2. Valuing of Self and Others

    Researcher created items to assess the extent to which students value themselves and others. Items were created based on positive youth development and dignity literature. Items comprise two subscales, one on self-value and the next on the value of others, each with eight statements. Participants are asked to rate the statements on a scale from "strongly disagree" (1) to "strongly agree" (4). One item in each section was reverse coded. Scores for the subscales were calculated by taking the average of the subscale items, with higher scores indicating better outcomes.

    Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)

  3. Sexual Consent

    Items adapted from Ewing et al., 2022 to assess attitudes towards sexual consent. Answer options included Strongly disagree (1) / Disagree (2) / Agree (3) / Strongly agree (4). Higher scale scores reflect more positive / healthier attitudes towards sexual consent.

    Time frame: Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)

  4. Bystander Readiness to Help

    The Denial Subscale of the Bystander Readiness to Help measure: participants rate five statements on a scale from "strongly disagree" (4) to "strongly agree" (1), with an option not to answer. The composite score is the mean of the five items, with higher scores indicating better outcomes.

    Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)

  5. Social Norms

    This scale is composed of a series of statements that gauged personal beliefs, perceptions of friends, and perceptions of other teens in the city, regarding their beliefs on sex trafficking. Participants rate statements on a scale from "strongly disagree" (1) to "strongly agree" (4), with an option not to answer. Items are summed, with higher scores indicating better outcomes.

    Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)

  6. Prevention Related Conversations with Adults

    Items to assess conversations (from students' perspectives) with adults about healthy relationships, valuing self and others, healthy relationship skills, sex trafficking, dating violence, and bystander intervention; participants rate statements on a scale from "strongly disagree" (1) to "strongly agree" (4), with an option not to answer. Items are summed, with higher scores indicating more frequent conversations with adults.

    Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)

  7. Online Risk Behaviors

    Items adapted from the UNH Technology Facilitated Abuse Survey and Global Kids Online Survey to assess online safety behaviors; participants report how often they engaged in these behaviors in the past month on a scale from "never" (0) to "several times each day" (5), with an option not to answer. Higher scores indicate more frequent engagement in potentially risky online behaviors.

    Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)

07

Study locations

1 of 1 sites recruiting
  • School/community center
    Des Moines, Iowa 50309, United States
    Recruiting
08

References and documents

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.
  • Jenkins N, Saiz C. The communication skills test. Unpublished manuscript, University of Denver, Denver, CO. 1995
  • Quinn-Nilas C, Milhausen RR, Breuer R, Bailey J, Pavlou M, DiClemente RJ, Wingood GM. Validation of the Sexual Communication Self-Efficacy Scale. Health Educ Behav. 2016 Apr;43(2):165-71. doi: 10.1177/1090198115598986. Epub 2015 Aug 17. PubMed 26286296 ↗
  • Edwards KM, Banyard VL, Sessarego SN, Stanley LR, Mitchell KJ, Eckstein RP, Rodenhizer KAE, Leyva PC. Measurement Tools to Assess Relationship Abuse and Sexual Assault Prevention Program Effectiveness Among Youth. Psychol Violence. 2018 Sep;8(5):537-545. doi: 10.1037/vio0000151. PubMed 31660253 ↗
  • Banyard VL. Measurement and correlates of prosocial bystander behavior: the case of interpersonal violence. Violence Vict. 2008;23(1):83-97. doi: 10.1891/0886-6708.23.1.83. PubMed 18396583 ↗
  • Waterman EA, Banyard VL, Edwards KM, Mauer VA. Youth perceptions of prevention norms and peer violence perpetration and victimization: A prospective analysis. Aggress Behav. 2022 Jul;48(4):402-417. doi: 10.1002/ab.22024. Epub 2022 Feb 16. PubMed 35174509 ↗
  • Edwards 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 32842824 ↗
  • 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 29295034 ↗
  • Monitoring the future national survey results on drug use, 1975-2020: Overview, key findings on adolescent drug use. https://eric.ed.gov/?id=ED611736
  • Johnston, Lloyd D.; Miech, Richard A.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.; Patrick, Megan E. (2022) Demographic Subgroup Trends among Adolescents in the Use of Various Licit and Illicit Drugs, 1975-2021. Monitoring the Future Occasional Paper Series. Paper 97. Institute for Social Research.
  • Franchino-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 34192962 ↗
  • Rothman EF, Farrell A, Paruk J, Bright K, Bair-Merritt M, Preis SR. Evaluation of a Multi-Session Group Designed to Prevent Commercial Sexual Exploitation of Minors: The "My Life My Choice" Curriculum. J Interpers Violence. 2021 Oct;36(19-20):9143-9166. doi: 10.1177/0886260519865972. Epub 2019 Jul 27. PubMed 31354019 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Data will be made available likely around fall 2027. It will be made available indefinitely.

Access criteria: See above in Plan Description.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Aug 2027, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2024
First posted
Sep 19, 2024
StartActual
Jul 8, 2024
Primary completionEst.
Aug 1, 2027
CompletionEst.
Aug 1, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • School/community center · Des Moines, United States
Show 1 removed
  • [school districts in the Midwest] · Des Moines, United States
Oct 7, 2026
Enrollment
3218→500
Oct 7, 2026
Eligibility
Maximum age 21 Years→19 Years; 1 inclusion criterion added, 2 removed
What changed in the criteria
Inclusion criteria
  • Removedenrolled in in Grade 9, 10, 11, or 12 at one of the eligible schools in the district
  • Removedable to understand spoken English
  • Addedare ages 13-19; (2) reside in the greater Des Moines/Polk County community; and (3) are able to understand spoken English.
Oct 7, 2026
Primary outcomes
Revised in 2 updates
What changed on Oct 7, 2026
  • RemovedCommercial Sexual Exploitation of Children (CSEC)-Victimization ExperiencesTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • Time frameCommercial Sexual Exploitation of Children (CSEC)-Perpetration ExperiencesTime 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
What changed on Oct 13, 2026
  • Time frameCommercial Sexual Exploitation of Children (CSEC)-Perpetration ExperiencesTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
across 2 updates, Oct 7, 2026 – Oct 13, 2026
Secondary outcomes
Revised in 2 updates
What changed on Oct 7, 2026
  • AddedCommercial Sexual Exploitation of Children (CSEC)-Victimization ExperiencesTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • AddedDating and Sexual Violence VictimizationTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • AddedDating and Sexual Violence PerpetrationTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • RemovedSexual AssaultTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedSexual HarassmentTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedStalkingTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedDating Violence (MARSHA)Time frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedYouth ViolenceTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedDepressionTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedAlcohol UseTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • RemovedAcademic and Career CommitmentTime frame: Time 1 (baseline), Time 2 (approximately three months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • Time frameCommercial Sexual Exploitation of Children (CSEC)-Bystander Opportunity and ActionTime 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameother outcomeCommercial Sexual Exploitation of Children (CSEC) KnowledgeTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameother outcomeEfficacy to Avoid Victimization (Efficacy)Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameother outcomeValuing of Self and OthersTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameother outcomeBystander Readiness to HelpTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameother outcomeSocial NormsTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameother outcomePrevention Related Conversations with School PersonnelTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
What changed on Oct 13, 2026
  • Time frameCommercial Sexual Exploitation of Children (CSEC)-Bystander Opportunity and ActionTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameCommercial Sexual Exploitation of Children (CSEC)-Victimization ExperiencesTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameDating and Sexual Violence VictimizationTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Time frameDating and Sexual Violence PerpetrationTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Editedother outcomePrevention Related Conversations with School PersonnelAdultsTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Addedother outcomeSexual ConsentTime frame: Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • Addedother outcomeOnline Risk BehaviorsTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Removedother outcomeEfficacy to Avoid Victimization (Efficacy)Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
  • Removedother outcomeHealthy Relationships SkillsTime frame: Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
  • Descriptionother outcomeSocial Norms: how it is measured was reworded
across 2 updates, Oct 7, 2026 – Oct 13, 2026
Show all 2 updates
  1. Oct 13, 2026
    Primary outcomes 1 time frame changed
    What changed in the outcomes
    • Time frameCommercial Sexual Exploitation of Children (CSEC)-Perpetration ExperiencesTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
    Secondary outcomes 1 edited, 4 time frame changed, 2 added, 2 removed, 1 description edited
    What changed in the outcomes
    • Time frameCommercial Sexual Exploitation of Children (CSEC)-Bystander Opportunity and ActionTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameCommercial Sexual Exploitation of Children (CSEC)-Victimization ExperiencesTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameDating and Sexual Violence VictimizationTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameDating and Sexual Violence PerpetrationTime 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program) → Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Editedother outcomePrevention Related Conversations with School PersonnelAdultsTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Addedother outcomeSexual ConsentTime frame: Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • Addedother outcomeOnline Risk BehaviorsTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Removedother outcomeEfficacy to Avoid Victimization (Efficacy)Time frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Removedother outcomeHealthy Relationships SkillsTime frame: Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • Descriptionother outcomeSocial Norms: how it is measured was reworded
  2. Oct 7, 2026
    1 site added, 1 site removed
    Show site
    • School/community center · Des Moines, United States
    Show 1 removed
    • [school districts in the Midwest] · Des Moines, United States
    Enrollment 3218→500
    Eligibility Maximum age 21 Years→19 Years; 1 inclusion criterion added, 2 removed
    What changed in the criteria
    Inclusion criteria
    • Removedenrolled in in Grade 9, 10, 11, or 12 at one of the eligible schools in the district
    • Removedable to understand spoken English
    • Addedare ages 13-19; (2) reside in the greater Des Moines/Polk County community; and (3) are able to understand spoken English.
    Primary outcomes 1 time frame changed, 1 removed
    What changed in the outcomes
    • RemovedCommercial Sexual Exploitation of Children (CSEC)-Victimization ExperiencesTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • Time frameCommercial Sexual Exploitation of Children (CSEC)-Perpetration ExperiencesTime 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    Secondary outcomes 7 time frame changed, 3 added, 8 removed
    What changed in the outcomes
    • AddedCommercial Sexual Exploitation of Children (CSEC)-Victimization ExperiencesTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • AddedDating and Sexual Violence VictimizationTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • AddedDating and Sexual Violence PerpetrationTime frame: Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • RemovedSexual AssaultTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedSexual HarassmentTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedStalkingTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedDating Violence (MARSHA)Time frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedYouth ViolenceTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedDepressionTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedAlcohol UseTime frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • RemovedAcademic and Career CommitmentTime frame: Time 1 (baseline), Time 2 (approximately three months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
    • Time frameCommercial Sexual Exploitation of Children (CSEC)-Bystander Opportunity and ActionTime 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameother outcomeCommercial Sexual Exploitation of Children (CSEC) KnowledgeTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameother outcomeEfficacy to Avoid Victimization (Efficacy)Time 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameother outcomeValuing of Self and OthersTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameother outcomeBystander Readiness to HelpTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameother outcomeSocial NormsTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    • Time frameother outcomePrevention Related Conversations with School PersonnelTime 1 (baseline), Time 2 (approximately 3 months post-baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline) → Time 1 (baseline), Time 2 (~2 weeks post-program), Time 3 (six months post-program), and Time 4 (12 months post-program)
    + 5 other changes: identifiers, verification date, description, design details and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06587529
Responsible party
Katie M Edwards (Professor, School of Social Work, University of Michigan) — Principal investigator
First posted
Sep 19, 2024
Start date
Jul 8, 2024
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Katie M Edwards, Ph.D.
Contact
edkatie@umich.edu
515-410-6536
Rochelle M Dalla, PhD
Contact
rdalla1@unl.edu
515-410-6536
Rochelle Dalla, PhD
study director · University of Nebraska Lincoln
Lorey Wheeler, PhD
study director · University of Nebraska Lincoln
Katie Edwards, Ph.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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