NCT05988398

Brief Summary

The overall goal of the 5-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Projects (SMFP) READY to Stand (RTS) curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

August 4, 2023

Results QC Date

April 10, 2025

Last Update Submit

May 28, 2025

Conditions

Keywords

Human TraffickingSex TraffickingSex CrimesCommercial SexCommercial Sexual Exploitation of ChildrenPrevention

Outcome Measures

Primary Outcomes (1)

  • Commercial Sexual Exploitation Children (CSEC) Perpetration (STUDENT Reported)

    For the initial pool of items, we identified existing CSEC perpetration items from The National Study on Adolescent to Adult Health (ADD Health; Franchino-Olsen et al., 2021) and The My Life My Choices evaluation study (Rothman et al., 2021). The scale consists of 21 statements and response options included yes, no, or I do not want to answer this question. A total score is calculated from the sum of the items, with higher scores reflective of a higher sex trafficking perpetration experiences in the past month.

    1-month post RTS delivery

Secondary Outcomes (13)

  • Commercial Sexual Exploitation of Children (CSEC) Victimization (STUDENT Reported)

    One-month post RTS delivery

  • Bystander Readiness to Help (STUDENT Reported)

    One-month post RTS delivery

  • Sexual Assault Victimization (STUDENT Reported)

    1-month post RTS delivery

  • Sexual Assault Perpetration (STUDENT Reported)

    One-month post RTS delivery

  • Sexual Harassment Victimization (STUDENT Reported)

    1-month post RTS delivery

  • +8 more secondary outcomes

Other Outcomes (11)

  • CSEC Knowledge (STUDENT Reported)

    1-month post RTS delivery

  • Efficacy (STUDENT Reported)

    1-month post RTS delivery

  • Valuing Self (STUDENT Reported)

    1-month post RTS delivery

  • +8 more other outcomes

Study Arms (1)

RTS Intervention

EXPERIMENTAL

RTS intervention will include a total of one 120-minute session of programming delivered to school personnel, and six, 45-minute sessions (total = 4.5 hours) for students. There are five components in this intervention that both students and school personnels will receive: 1) Psychoeducation on CSEC, 2) Healthy relationship skills training, 3) Programming components to enhance valuing of self and others, 4) Bystander intervention skills, and 5) Social norms for both students and school personnel. Students will additionally receive programming on Identification of safe people and resources, while school personnel will receive programming on Responding to Student Disclosures, and Cultural Humility.

Behavioral: READY To Stand Curriculum

Interventions

Students will receive the RTS programming over six consecutive school days, spread over two 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
RTS Intervention

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For school personnel, participants must be 18 years of age or older and currently employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS for the survey development portion of the study (Aim 1g). We will include anyone working in administration (e.g., principal), teaching (e.g., academic subject matter instructor) or support service (e.g., counselor) capacity within any of the eight high schools encompassed within Des Moines Public School (DMPS) system.
  • For students, participants must be in Grades 9 through 12 at one of the eight participating high schools in DMPS and be able to understand spoken English. For the OPT (Aims 1e, 1h) this includes Hoover and All Points.

You may not qualify if:

  • For school personnel, not being 18 or older or currently employed at Hoover or All Points for the OPT and one of the eight high schools in DMPS.
  • For students, being in Grades younger than 9 or older than 12 and not being enrolled in participating high school in DMPS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

[a school district in the Midwest]

Des Moines, Iowa, 50047, United States

Location

Related Publications (28)

  • Prevention CfDCa. Rigorously Evaluating Programs and Policies to Prevent Child Sexual Abuse (CSA) RFA-CE-22-003. 2021

    BACKGROUND
  • Anderson PM, Coyle KK, Johnson A, Denner J. An exploratory study of adolescent pimping relationships. J Prim Prev. 2014 Apr;35(2):113-7. doi: 10.1007/s10935-014-0338-3.

    PMID: 24445410BACKGROUND
  • American Association of University Women Educational Foundation. Hostile hallways: Bullying, teasing, and sexual harassment in school. ERIC; 2001.

    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
  • 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
  • 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
  • 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, 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
  • Edwards KM, Littleton H. Development and pilot evaluation of an online intervention to prevent dating violence and problem drinking in sexual minority youth. University of Nebraska Lincoln, Lincoln, NE: National Institute of Health; 2021-2023.

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

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

    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
  • 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
  • Park N. Character strengths and positive youth development. Annals of the American Academy of Political and Social Science. 2004;591(1):40-54. doi:10.1177/0002716203260079

    BACKGROUND
  • Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

    PMID: 20957426BACKGROUND
  • Project P. COMPREHENSIVE HUMAN TRAFFICKING ASSESSMENT. 2011

    BACKGROUND
  • Project SMF. READY to Stand Curriculum. 2021

    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
  • Quirk, K., Newcomb, M. E., & Mustanski, B. (2018). LGBQ identity integration and the association with justification of violence. Psychology of Violence, 8(2), 184.

    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
  • 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
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND
  • 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

MeSH Terms

Conditions

Sex WorkCoitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Results Point of Contact

Title
Dr. Katie M Edwards
Organization
University of Michigan

Study Officials

  • Katie M Edwards, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR
  • Rochelle Dalla, PhD

    University of Nebraska Lincoln

    STUDY DIRECTOR
  • Lorey Wheeler, PhD

    University of Nebraska Lincoln

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Two Schools will receive the intervention in addition to pre- and post- surveys. There is no control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

May 29, 2024

Study Completion

May 29, 2024

Last Updated

May 30, 2025

Results First Posted

May 30, 2025

Record last verified: 2025-05

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 DMPS. 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 summer 2025. It will be made available indefinitely.
Access Criteria
See above in Plan Description

Locations