Clinical trial NCT06587529: Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sex Trafficking
Sex Crimes
Commercial Sex
Sexual Violence
Child Abuse, Sexual
Sex Offense
Keywords: Human Trafficking
Sex Trafficking
Sex Crimes
Commercial Sex
Commercial Sexual Exploitation of Children
Prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 3218
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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).

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)

Primary outcomes:
measure: Commercial Sexual Exploitation of Children (CSEC)-Victimization Experiences
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Commercial Sexual Exploitation of Children (CSEC)-Perpetration Experiences
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
Secondary outcomes:
measure: Commercial Sexual Exploitation of Children (CSEC)-Bystander Opportunity and Action
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Sexual Assault
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Sexual Harassment
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Stalking
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Dating Violence (MARSHA)
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Youth Violence
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Depression
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Alcohol Use
timeFrame: Time 1 (baseline), Time 3 (six months post-baseline), Time 4 (twelve months post-baseline, Time 5 (eighteen months post-baseline)
measure: Academic and Career Commitment
timeFrame: 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)
Other outcomes:
measure: Commercial Sexual Exploitation of Children (CSEC) Knowledge
timeFrame: 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)
measure: Efficacy to Avoid Victimization (Efficacy)
timeFrame: 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)
measure: Valuing of Self and Others
timeFrame: 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)
measure: Healthy Relationships Skills
timeFrame: 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)
measure: Bystander Readiness to Help
timeFrame: 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)
measure: Social Norms
timeFrame: 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)
measure: Prevention Related Conversations with School Personnel
timeFrame: 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)
Locations:
city: Des Moines
country: United States
facility: [school districts in the Midwest]
state: Iowa
Study officials:
affiliation: University of Nebraska Lincoln
name: Rochelle Dalla, PhD
role: STUDY_DIRECTOR
affiliation: University of Nebraska Lincoln
name: Lorey Wheeler, PhD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Katie Edwards, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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