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

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 the five-year 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).

Study Overview

• Status: Recruiting
• Conditions: Sexual Violence; Sex Trafficking; Child Abuse, Sexual; Sex Crimes; Commercial Sex; Sex Offense
• Intervention / Treatment: Behavioral: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum

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 both students and school personnel. Student programming includes six, 45-minute modules implemented to high school students in mixed gender groups of ~25 students and provides students 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. School personnel participate in a training to equip them with skills to effectively respond to students' disclosures of CSEC, enhance cultural humility, and reinforce programming messages. Despite its potential for reducing CSEC, the RTS© has never been evaluated.

The investigators will conduct a quasi-experimental design study in which four traditional high schools and two alternative high schools (not including the two high schools that participated in NCT05988398) are assigned to treatment or control conditions. Students enrolled in spring elective courses (e.g., healthy relationships, psychology) in the four traditional high schools and all students in the two alternative high schools (n=3,218 [enrolled]) will complete baseline and immediate post, 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 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) (Aim 2a). The investigators 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=1,459 students [enrolled in treatment schools]; n=150 school personnel [enrolled in treatment schools]) (Aim 2d), and post program implementation of 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 (Aim 2f).

• Study Type: Interventional
• Enrollment (Estimated): 3218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie M Edwards, Ph.D.; Phone Number: 515-410-6536; Email: edkatie@umich.edu
• Study Contact Backup: Name: Rochelle M Dalla, PhD; Phone Number: 515-410-6536; Email: rdalla1@unl.edu

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50047
      • Recruiting
      • [school districts in the Midwest]
      • Contact: Jennifer Stalder; Phone Number: (515) 242-8394; Email: mailto:jennifer.stalder@dmschools.org
      • Contact: Stacie Nessa; Phone Number: (515) 778-1972; Email: Stacie.Nessa@dmschools.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• enrolled in in Grade 9, 10, 11, or 12 at one of the eligible schools in the district
• able to understand spoken English

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; control
Experimental: Treatment; READY to Stand© curriculum	Behavioral: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum; Students will receive the Ready to Stand (RTS)© programming over six school days, spread over six 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.; Other Names: RTS©

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
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 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Sexual Assault	Behaviorally worded items to assess students' self-reports of experiencing sexual assault victimization and perpetration; answers are binary (Yes/No) with an option not to answer. Items are summed, with higher scores indicating worse outcomes.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Sexual Harassment	Behaviorally worded items to assess students' self-reports of experiencing sexual harassment victimization and perpetration; answers are binary (Yes/No) with an option not to answer. Items are summed, with higher scores indicating worse outcomes.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Stalking	Behaviorally worded items to assess students' self-reports of experiencing stalking victimization and perpetration; answers are binary (Yes/No) with an option not to answer. Items are summed, with higher scores indicating worse outcomes.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Dating Violence (MARSHA)	Behaviorally worded items to the Measure of Adolescent Relationship Harassment and Abuse (MARSHA) will be used to assess dating violence victimization and perpetration. Each subscale was summed so that higher scores indicate higher frequencies of Intimate Partner Violence (IPV), a worse outcome. Each subscale is also dichotomized to represent the absence or presence of that type of IPV.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Youth Violence	Behaviorally worded items from the Youth Risk Behavior Surveillance System (YRBSS) will be used to measure physical fights, fear of going to school, and weapon carrying; answers are binary (Yes/No) with an option not to answer. Items are summed, with higher scores indicating worse outcomes.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Depression	The Patient Health Questionnaire (PHQ-9) modified will be used to measure depression; items are rated from 0 ("Not at all") to 3 ("Nearly every day"). Higher scores indicate higher depressive symptomology, a worse outcome.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Alcohol Use	Items from Monitoring the Future will be used to measure past month alcohol use and alcohol intoxication; items are rated from 0 ("0 times") to 9 ("40+ times"), with higher scores indicating worse outcomes.	Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Academic and Career Commitment	Items to measure students' intentions on graduating high school/getting a GED as well as having a job/career, rated from 1 ("not true at all of me") to 4 ("extremely true of me"), with an option not to answer. A total score is calculated by taking the average of the five items, with higher scores indicating better outcomes.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)
Efficacy to Avoid Victimization (Efficacy)	Researcher created items to assess confidence in resistance to being a victim of commercial sexual exploitation of children (CSEC). Answer options ranged from "not at all confident" (1), "somewhat confident" (2), to "very confident" (3), with an option not to answer. Items are summed with higher scores indicating better outcomes.	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)
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 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)
Healthy Relationships Skills	Items adapted from the Communications Skills Test and Sexual Communication Self-Efficacy Scale to assess conflict management and sexual refusal skills, used to assess students' communication skills with a romantic partner. In addition, two items were created by the researchers to assess consent and respecting boundaries that are based on the READY to Stand© program. Answer options included "very difficult" (1), "difficult" (2), "easy" (3), and "very easy" (4). Higher scale scores reflect healthier relationship communication skills, a better outcome.	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)
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 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)
Social Norms	This scale is composed of a series of statements that gauged personal beliefs, perceptions of friends, perceptions of other high school students in this district, and perceptions of school personnel in the district 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 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)
Prevention Related Conversations with School Personnel	Items to assess conversations (from students' perspectives) with school personnel 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 better outcomes.	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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Study Director: Rochelle Dalla, PhD, University of Nebraska Lincoln; Study Director: Lorey Wheeler, PhD, University of Nebraska Lincoln; Principal Investigator: Katie Edwards, Ph.D., University of Michigan

Publications and helpful links

General Publications

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• 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.
• 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.
• 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
• 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.
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• 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.
• 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.
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• Monitoring the future national survey results on drug use, 1975-2020: Overview, key findings on adolescent drug use. https://eric.ed.gov/?id=ED611736.
• Project SMF. READY to Stand Curriculum. 2021
• 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.
• 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.
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Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; Human Trafficking; Sex Trafficking; Sex Crimes; Commercial Sex; Commercial Sexual Exploitation of Children
• Additional Relevant MeSH Terms: Behavior; Sexual Behavior; Coitus; Sex Work
• Other Study ID Numbers: 23657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The level of public access will be restricted such that the data set will be available under certain use restrictions. More specifically, the PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send the approved researcher the dataset prepared using SPSS 27.0 (or the latest version available). The prepared data set will not include identifying information about participants, schools, or 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.
• IPD Sharing Time Frame: Data will be made available likely around fall 2027. It will be made available indefinitely.
• IPD Sharing Access Criteria: See above in Plan Description.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No