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NCT Number: NCT06587529

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

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).

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Key information

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Behavioral

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©

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    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.

  2. Sexual Assault

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

    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.

  3. Sexual Harassment

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

    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.

  4. Stalking

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

    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.

  5. Dating 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)

    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.

  6. Youth Violence

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

    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.

  7. Depression

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

    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.

  8. Alcohol Use

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

    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.

  9. Academic and Career Commitment

    Time 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)

    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.

Other outcomes

  1. Commercial Sexual Exploitation of Children (CSEC) Knowledge

    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)

    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.

  2. Efficacy to Avoid Victimization (Efficacy)

    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)

    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.

  3. Valuing of Self and Others

    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)

    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.

  4. Healthy Relationships Skills

    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)

    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.

  5. Bystander Readiness to Help

    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)

    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.

  6. Social Norms

    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)

    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.

  7. Prevention Related Conversations with School Personnel

    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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie M Edwards, Ph.D.

CONTACT

[email protected]

515-410-6536

Rochelle M Dalla, PhD

CONTACT

[email protected]

515-410-6536

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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