NCT06587529

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,218

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2024Aug 2027

Study Start

First participant enrolled

July 8, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

July 29, 2024

Last Update Submit

January 23, 2026

Conditions

Sex TraffickingSex CrimesCommercial SexSexual ViolenceChild Abuse, SexualSex Offense

Keywords

Human TraffickingSex TraffickingSex CrimesCommercial SexCommercial Sexual Exploitation of ChildrenPrevention

Outcome Measures

Primary Outcomes (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 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 Outcomes (9)

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

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

  • Sexual Assault

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

  • Sexual Harassment

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

  • Stalking

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

  • +4 more secondary outcomes

Other Outcomes (7)

  • Commercial Sexual Exploitation of Children (CSEC) Knowledge

    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)

    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

    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 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

READY to Stand© curriculum

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

Control

NO INTERVENTION

control

Interventions

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

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.

Also known as: RTS©
Treatment

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

[school districts in the Midwest]

Des Moines, Iowa, 50047, United States

RECRUITING

Related Publications (26)

  • 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: 35303249BACKGROUND

  • 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: 25255794BACKGROUND

  • Lipson, J. (2001). Hostile hallways: Bullying, teasing, and sexual harassment in school. AAUW Educational Foundation, 1111 Sixteenth Street, NW, Washington, DC 20036.

    BACKGROUND

  • 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: 32627640BACKGROUND

  • 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

    BACKGROUND

  • 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: 11869927BACKGROUND

  • Monitoring the future national survey results on drug use, 1975-2020: Overview, key findings on adolescent drug use. https://eric.ed.gov/?id=ED611736.

    BACKGROUND

  • Hulsey L., Zief, S., & Murphy, L. PREP Entry and Exit Survey Measures Guide. 2022. https://www.prepeval.com/DataCollection/50273%20Data%20Dictionary%202022.pdf

    BACKGROUND

  • Project SMF. READY to Stand Curriculum. 2021

    BACKGROUND

  • 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.

    BACKGROUND

  • Lebech M. What is human dignity? Maynooth philosophical papers. 2004;2:59-69.

    BACKGROUND

  • Bal M. A Review of Human Dignity. Dignity in the Workplace. 2017:41-66.

    BACKGROUND

  • 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.

    PMID: 20397040BACKGROUND

  • Park, N. (2004). Character strengths and positive youth development. The Annals of the American Academy of Political and Social Science, 591(1), 40-54.

    BACKGROUND

  • 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.

    BACKGROUND

  • Jenkins N, Saiz C. The communication skills test. Unpublished manuscript, University of Denver, Denver, CO. 1995

    BACKGROUND

  • 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.

    PMID: 26286296BACKGROUND

  • 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.

    PMID: 31660253BACKGROUND

  • 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.

    PMID: 18396583BACKGROUND

  • 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.

    PMID: 35174509BACKGROUND

  • 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.

    PMID: 32842824BACKGROUND

  • 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.

    PMID: 29295034BACKGROUND

  • Monitoring the future national survey results on drug use, 1975-2020: Overview, key findings on adolescent drug use. https://eric.ed.gov/?id=ED611736

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 34192962BACKGROUND

  • 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.

    PMID: 31354019BACKGROUND

MeSH Terms

Conditions

Sex WorkCoitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Rochelle Dalla, PhD

    University of Nebraska Lincoln

    STUDY DIRECTOR

  • Lorey Wheeler, PhD

    University of Nebraska Lincoln

    STUDY DIRECTOR

  • Katie Edwards, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie M Edwards, Ph.D.

CONTACT

515-410-6536edkatie@umich.edu

Rochelle M Dalla, PhD

CONTACT

515-410-6536rdalla1@unl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Social Work

Study Record Dates

First Submitted

July 29, 2024

First Posted

September 19, 2024

Study Start

July 8, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US(1)