Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06587529

Conditions

Sex Trafficking

Sex Crimes

Commercial Sex

Sexual Violence

Child Abuse, Sexual

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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).

Conditions

Sex Trafficking

Sex Crimes

Commercial Sex

Sexual Violence

Child Abuse, Sexual

Study ID

NCT06587529

Start date

Jul 8, 2024

Status verified date

Oct, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Accepted

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:

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment

READY to Stand© curriculum

active comparator: Control

Nutritional workshop delivered by a dietician

Interventions

The 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.

Primary outcome measure

  • Commercial Sexual Exploitation of Children (CSEC)-Perpetration Experiences [ Time Frame: Time 1 (baseline), Time 3 (six months post-program), and Time 4 (12 months post-program) ]

Central Contacts and Locations

Central contacts

Katie M Edwards, Ph.D.

515-410-6536edkatie@umich.edu

Rochelle M Dalla, PhD

515-410-6536rdalla1@unl.edu

Locations

School/community center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Katie Edwards, Ph.D.

734-647-8812edkatie@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Human Trafficking
  • Sex Trafficking
  • Sex Crimes
  • Commercial Sex
  • Commercial Sexual Exploitation of Children
  • Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.