- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722769
CSTOP Now! Child Sex Trafficking Stops With You
RCT to Evaluate Bystander-informed CSTOP Now! to Prevent Child Sex Trafficking in Kentucky Middle Schools
Focus: Intervention & prevention of child commercial sexual exploitation or trafficking (CST) In Kentucky, familial SU/D increases risk of CST.
Primary goal: Implement and evaluate effectiveness of multi-level bystander-informed program (CSTOP Now!) aimed at Kentucky public middle schools for staff.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Randomization will occur at the Kentucky county level among 50 counties with at least 2 middle schools for a middle school-based cluster RCT set in 50 of Kentucky's 120 counties. Middle schools in half (n=25) of the 50 Kentucky counties will be randomized to the intervention condition, while middle schools in the remaining 25 Kentucky counties will be randomly assigned to the attention control. We have selected counties that are similar in population size, demographics (% white, % <18 years of age, and % living in poverty, using 2019 Census estimates). Within each county, all middle schools (>200 across 50 counties) will be invited to participate in this RCT.
Participating staff will be emailed a link that will take them to a description of the study. Participation will involve receipt of online training, as randomized at the county level, and completing surveys immediately before receipt of the first training and at the end of each of school terms annually.
Aim 1. Evaluate the effectiveness of child sex trafficking (CST) prevention training implemented among middle school staff randomized, at the Kentucky county level, to change middle school staff:
- Knowledge of child sexual exploitation and trafficking (hypothesize greater knowledge in Intervention versus Control),
- Attitudes towards child sexual exploitation and trafficking (hypothesize lower stigma in Intervention versus Control),
- Willingness and efficacy to intervene (hypothesize greater efficacy in Intervention versus Control),
- Use of 'bystander' actions to thwart child sexual exploitation and trafficking risk (hypothesize increase actions in Intervention versus Control),
- Use child sex trafficking screening, referral and reporting (hypothesize increase actions in Intervention versus Control),
Aim 2. Evaluate effectiveness of child sex trafficking mass media intervention (Intervention versus Control), randomized and measured at the Kentucky county-level, based on middle school staff survey data:
- To increase child sexual exploitation and trafficking screening & reporting in short term (Years 1-2),
- Begin to reduce child sexual exploitation and trafficking rates in longer term (Year 3-4) Analyses for both aims will be adjusted for school and county-level attributes
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily Clear, MPH
- Phone Number: 859-218-0029
- Email: emily.clear@uky.edu
Study Contact Backup
- Name: Ann Coker, PhD, MPH
- Phone Number: 859-323-0429
- Email: ann.coker@uky.edu
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536-0293
- Recruiting
- University Of Kentucky
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Principal Investigator:
- Ann L. Coker, PhD, MPH
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Principal Investigator:
- Ginny Sprang, PhD
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Sub-Investigator:
- Heather M. Bush, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Kentucky middle school staff in a public school
- Kentucky middle school staff in the intervention or attention control schools/counties.
Exclusion Criteria:
- Kentucky middle school staff not in intervention or attention control schools/counties.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CSTOP Now! Child Sex Trafficking Stops with You
For this RCT, our research team has created CSTOP Now! online, interactive learning management system training.
This CSTOP Now! online training will be offer to middle school staff in Kentucky counties randomized to this experimental intervention arm.
This training seeks to provide middle school staff with information and resources to identify, intervene in, and prevent child sex trafficking (CST).
This training will provide middle school staff with the knowledge, skills, and efficacy to intervene with children at risk of or experiencing CST.
This training will also provide staff with skills to disrupt harmful attitudes or misinformation about CST.
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Child sex trafficking stops with you.
Implement and evaluate the effectiveness of a multi-level bystander-informed program (CSTOP Now!) aimed at Kentucky public middle school staff.
Participants will be trained to use the See It To Stop It Indicator Tool (SITSII) by using tiers of concern (clear concern, possible concern, and monitor of emerging concern).
The SITSII tool directs the bystander actions to Decide, Directly Intervene, Disrupt, Delegate, and Document.
|
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Active Comparator: Prevent Child Abuse Kentucky Online Training
With input from Prevent Child Abuse Kentucky, our team developed training delivered via LMS and designed to identify child sex trafficking among middle school students.
Only for middle school staff in counties randomized to the active comparator, we offer this online training using the same approach as that for staff in the intervention condition.
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The Kentucky State Police, in association with Prevent Child Abuse Kentucky, have developed videos we invite active comparator schools to review which also include how to identify and report child sex trafficking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge and Attitudes toward Child Sex Trafficking (CST) among middle school staff
Time Frame: Year 2-Year 4
|
Knowledge of CST to include legal and behavioral definitions, risk factors, signs and symptoms, and awareness CST in staff's school or community Attitudes toward CST include stereotypes of those trafficked, their families and consumers, staff's empathy and attitudes toward helping those trafficked, self-efficacy to address CST with students or staff. Sex Trafficking Attitudes Scale, Human Trafficking Myths Scale, Adaptation of Self-Confidence and Screening Behaviors for Domestic Violence Scale |
Year 2-Year 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of bystander actions and See It To Stop It Indicator (SITSII) screening tool
Time Frame: Year 2-Year 4
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Use of active bystander behaviors to prevent or stop child sex trafficking. Bystander behaviors to include the number of events reported by middle school staff to include directly intervene, delegate, disrupt, and document of behaviors to prevent child sex trafficking or report potential child sex trafficking. Based on Banyard, Plante, Moynihan (2005) Bystander Efficacy Scale and adapted for child sex trafficking. |
Year 2-Year 4
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann L. Coker, PhD, MPH, University Of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 77232
- U01CE003394 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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