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Recruiting NCT06587529

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

No phase Interventional Sex Trafficking Sex Crimes Commercial Sex Sexual Violence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Set Me Free Project's (SMFP) READY to Stand (RTS)© Curriculum.
Who it may be relevant to
Registry conditions: Sex Trafficking, Sex Crimes, Commercial Sex, Sexual Violence. Basic parameters: 13 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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).

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).

Interventions

  • 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 y

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (9)
  • 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)]
  • 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)]
  • 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)]
  • Stalking [Time frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)]
  • 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)]
  • 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)]
  • Depression [Time frame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)]
  • 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)]
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • [school districts in the Midwest] — Des Moines

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. PMID 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. PMID 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. PMID 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. PMID 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

Identifiers

NCT: NCT06587529 · 23657

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗