Preventing Commercial Sexual Exploitation of Children

Sexual Violence Clinical Trial

— Project LIVE  

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 II: OPEN PILOT TRIAL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988398
• Other study ID #: 22811
• Secondary ID: 1U01CE003405
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: University of Nebraska Lincoln
• Contact: Aleesa K Nutting, MA
• Phone: 5154106536
• Email: anutting2[@]unl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Detailed Description: The commercial sexual exploitation of children (CSEC) is a public health crisis in the U.S.1-4 Research has documented risk and protective factors across the social ecology for CSEC,2,5-8 that many perpetrators (traffickers, clients, recruiters) of CSEC are peers (e.g., romantic partners) 9-11 and adolescents report opportunities to intervene in situations of peer victimization (although not necessarily specific to CSEC).12-14 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-that includes researchers, educators, practitioners, and youth-is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project's© (SMFP) READY to Stand (RTS)© curriculum-with an eye toward widespread dissemination to other U.S. communities, if deemed effective. This project is responsive to Research Priority Area 4 (preventing CSEC as a form of CSA) of RFA-CE-22-003. The implementation site includes eight high schools in Des Moines Public Schools (DMPS); students (naïve to the RTS curriculum) are largely racial/ethnic minority (65%) and low-income (76%). DMPS leadership have expressed a growing concern about the CSEC in their district and are eager to partner with researchers to rigorously evaluate the RTS curriculum. The RTS curriculum includes four, 45-minute modules implemented to high school students in mixed gender groups of ~25 students and provides students with psychoeducation on CSEC, healthy relationship skills training, identification of safe people/resources, and programming components to enhance valuing of self and others. As part of the proposed project, the RTS curriculum will be enhanced with two additional 45-minute modules on bystander intervention training in situations of CSEC and shifting school norms to be intolerant of all forms of violence, including CSEC. Additionally, school personnel participate in an enhanced (from 90 minutes to 120 minutes) training to equip them with skills to effectively respond to students' disclosures of CSEC and to reinforce programming messages. The RTS curriculum may also reduce other forms of violence such as teen dating violence (TDV) given it addresses risk and protective factors for multiple forms of violence. Despite its potential for reducing CSEC, the RTS curriculum has never been evaluated. Specific Aims are as follows: Refinement and Planning Phase (Component A): Convene a Research Advisory Board (RAB) that includes researchers, practitioners, educators, caregivers, and youth who will provide input on all research components of the project (Aim 1a). Conduct focus groups with students (n=80) and school personnel (n=60) to inform the refinement of the RTS curriculum and research procedures for Component B (Aim 1b). Enhance the existing RTS program manual and create a training manual to ensure consistent implementation, produce training manuals for use in subsequent clinical trials and dissemination, and develop fidelity measures (Aim 1c). Develop via cognitive interviews (n=20 youth, n=10 school personnel) and surveys (n=878) with students valid, reliable, and developmentally appropriate measures of CSEC perpetration, CSEC victimization, and CSEC bystander opportunity/action to be used in subsequent research, including Component B (Aim 1d). Conduct an open pilot trial of the RTS curriculum in one of the five traditional high schools and one of the three alternative schools in DMPS with students (n=878) and school personnel (n=78) to gain experience with the recruitment and assessment procedures and administration of the intervention; assess acceptability and safety of the research protocols; document initial trends, effect sizes, and CSEC incidence rates; and refine the intervention and research procedures in preparation for Component B (Aim 1e). Apply for additional funding under Component B and disseminate findings to diverse audiences in collaboration with the RAB (Aim 1f). All procedures for Component B will be ready for implementation by the end of Component A funding. Rigorous Evaluation Phase (Component B): Conduct a quasi-experimental study in which four traditional high schools in DMPS and two alternative high schools (not including the two high schools that participated in Component A) are demographically matched and randomly assigned to treatment or wait-list control conditions. Students (n=7,241) will complete baseline and 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 TDV and sexual violence victimization and perpetration and increases in bystander intervention in CSEC situations compared to participants in the waitlist control condition (secondary outcomes) (Aim 2a). We 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=7,241 students; n=396 school personnel) (Aim 2d), and post-program implementation 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 curriculum (Aim 2f). Refine and assess validity and reliability of school personnel's' CSEC prevention related knowledge, attitudes, and skills (Aim 1g). Examine the preliminary impact of the RTS school personnel training curriculum on CSEC prevention related knowledge, attitudes, and skills as well as acceptability and perceptions of impact (Aim 1h).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 956
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Child Abuse, Sexual
• Sex Trafficking
• Sexual Violence

Intervention

Behavioral:
• READY To Stand Curriculum
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.

Locations

Country	Name	City	State
United States	[a school district in the Midwest]	Des Moines	Iowa

Sponsors (4)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	Centers for Disease Control and Prevention, Des Moines Public Schools, The Set Me Free Project

Country where clinical trial is conducted

United States, 

References & Publications (28)

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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

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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

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.

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

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

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

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. — View Citation

Project P. COMPREHENSIVE HUMAN TRAFFICKING ASSESSMENT. 2011

Project SMF. READY to Stand Curriculum. 2021

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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.

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CSEC Knowledge (STUDENT Reported)	Author created items to assess knowledge about CSEC (that aligns with the student programming being received)	Baseline and 1 month post RTS delivery
Other	Efficacy (STUDENT Reported)	Author created items to assess confidence in resistance to being a victim of CSEC	Baseline and 1 month post RTS delivery
Other	Valuing Self and Others (STUDENT Reported)	Author created items to assess the extent to which students value themselves and others. Items were created based on positive youth development and dignity literatures.	Baseline and 1 month post RTS delivery
Other	Healthy Relationship Skills (STUDENT Reported)	Items adapted from the Communications Skills Test (Jenkins & Saiz, 1995) and Sexual Communication Self-Efficacy Scale (Quinn-Nilas et al., 2016). to assess conflict management and sexual refusal skills.	Baseline and 1 month post RTS delivery
Other	Bystander Readiness to Help (STUDENT Reported)	The denial subscale of the Bystander Readiness to Help measure was adapted from Banyard et al. 2008 and Edwards et al 2018	Baseline and 1 month post RTS delivery
Other	Perceptions of Social Norms of Prevention of CSEC (STUDENT Reported)	Items adapted from previous research to assess perceptions of self, friends, students, and school personnel regarding unacceptability and role to play in prevention of CSEC (Waterman et al. 2022).	Baseline and 1 month post RTS delivery
Other	Prevention-related Communication with School Personnel (STUDENT Reported)	Items to assess conversations (from students' perspectives) with school personnel about healthy relationships, valuing self and others, healthy relationship skills, CSEC, dating violence, and bystander intervention were adapted from Edwards et al., 2020.	Baseline and 1 month post RTS delivery
Other	CSEC Bystander Intentions (SCHOOL PERSONNEL Reported)	Items adapted from Edwards et al 2017 to assess school personnel's intentions of engaging in behaviors to prevent CSEC and effectively respond to CSEC survivors.	Baseline and 1 month post RTS delivery
Other	Perceptions of Social Norms of Prevention of CSEC (SCHOOL PERSONNEL Reported)	Items adapted from previous research to assess perceptions of self, students, and school personnel regarding unacceptability and role to play in prevention of CSEC (Waterman et al. 2022).	Baseline and 1 month post RTS delivery
Other	Prevention-related Communication with School Personnel (SCHOOL PERSONNEL Reported)	Items to assess conversations (from school personnel perspectives) with school personnel about healthy relationships, valuing self and others, healthy relationship skills, CSEC, dating violence, and bystander intervention were adapted from Edwards et al., 2020.	Baseline and 1 month post RTS delivery
Other	CSEC Knowledge (SCHOOL PERSONNEL Reported)	Author created items to assess knowledge about CSEC (that aligns with the school personnel programming being received)	Baseline and 1 month post RTS delivery
Other	Cultural Humility (SCHOOL PERSONNEL Reported)	The Multicultural Teaching Competency Scale (Spanierman et al., 2011) was used to assess cultural humility and includes the following subscales: Multicultural teaching skills, Multicultural teaching knowledge	Baseline and 1 month post RTS delivery
Primary	Commercial sexual exploitation of children (CSEC) Victimization and Perpetration (STUDENT Reported)	Behaviorally worded items to assess students' self-reports of experiencing CSEC perpetration and victimization. Items Adapted from Add Health data (Franchino-Olsen et al., 2021), my Choices evaluation study (and Rothman et al., 2021), and the Polaris Project (2011).	Baseline and 1 month post RTS delivery
Secondary	CSEC Bystander Opportunity and Action (STUDENT Reported)	Items assess past month bystander opportunity and action in situations of CSEC Adapted from Edwards et al. 2022	Baseline and 1 month post RTS delivery
Secondary	Sexual assault victimization and perpetration (STUDENT Reported)	Behaviorally worded items to assess students' self-reports of experiencing past month sexual assault victimization and perpetration (Cook-Craig et al. 2014)	Baseline and 1 month post RTS delivery
Secondary	Sexual harassment (STUDENT Reported)	Behaviorally worded items to assess past month students' self-reports of experiencing sexual harassment victimization and perpetration. Items from American Association of University Women Educational Foundation (2001)	Baseline and 1 month post RTS delivery
Secondary	Stalking (STUDENT Reported)	Behaviorally worded items to assess students' past month self-reports of experiencing stalking victimization and perpetration (Cook-Craig et al. 2014)	Baseline and 1 month post RTS delivery
Secondary	Dating Violence (STUDENT Reported)	The Measure of Adolescent Relationship Harassment and Abuse (MARSHA; Rothman et al. 2020) was used to assess past month dating violence victimization and perpetration. Subscales include: Physical abuse and Isolation.	Baseline and 1 month post RTS delivery
Secondary	Youth Violence (STUDENT Reported)	The Youth Risk Behavior Surveillance System (Centers for Disease Control and Prevention, 2019) was used to measure past month physical fights, fear of going to school, and weapon carrying.	Baseline and 1 month post RTS delivery
Secondary	Depression (STUDENT Reported)	The Patient Health Questionnaire (PHQ-9) modified (Johnson et al. 2002) was used to measure past two week depression.	Baseline and 1 month post RTS delivery
Secondary	Alcohol Use (STUDENT Reported)	Items from Monitoring the Future (Johnston et al. 2021) were used to measure past month alcohol use and alcohol intoxication.	Baseline and 1 month post RTS delivery.
Secondary	Academic & Career Commitment (STUDENT Reported)	Items from Hulsey et al. 2022 were used to measures students intentions on graduating high school/getting a GED as well as having a job/career.	Baseline and 1 month post RTS delivery