- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07503912
Evaluation of the Not A Number Trafficking Prevention Program in Minnesota
Randomized Controlled Trial Evaluation of the Not A Number Trafficking Prevention Program in MN
Although the exact scope of commercial sexual exploitation of children (CSEC) remains unknown, its significant negative physical and emotional consequences for children has been well-documented. The U.S. government recognized the need for improved CSEC prevention over two decades ago and recent legislation has been introduced to further increase funding for prevention programs. However, there is little evaluation research to guide communities on best practices, and questions remain about how to most effectively approach primary prevention for CSEC.
This study involves a randomized controlled trial (RCT) evaluation of the Not a Number (NAN)- a CSEC prevention program. NAN, developed by the non-profit organization Love 146, is delivered nationally with a unique train-the-trainer model in Minnesota to reach youth at heightened risk for CSEC victimization.
The RCT will be conducted at 32 implementation sites (15 youth enrolled as participants per site, N=480), with sites randomly assigned to an implementation or a wait-list control condition. We will examine a range of program outcomes, including a reduction in CSEC victimization (primary outcome), through a pre-test/post-test design (follow-up data collection at 6 weeks, 6 months, and 12 months).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A two-arm cluster randomized controlled trial study is planned with an aim of enrolling 480 youth (13-17 years old) to participate from 32 partner agencies (approximately 15 youth per agency). Subjects will be enrolled from 4 cohorts of 6-10 implementation sites in each of four waves quarterly over a year (for a total of 32 sites). Each cohort of six to ten agencies per wave will be systematically paired using agency-level characteristics such as size and youth client demographics. Each agency in a pair will then be randomly assigned to either an implementation condition or a wait-list control condition.
Youth at agencies in the implementation condition will be provided with the Not a Number (NAN) program immediately after baseline measurement, with youth at the wait-list control sites offered a 30-minute mindfulness training program (placebo condition) and an opportunity to receive the program six months later.
Youth at all sites will be provided with information about the study and invited to participate by key contacts at each partner agency. We will work with each partner site to identify optimal strategies for approaching youth and legal guardians about the study given their population of youth, their programmatic structure, and their relationship with families. All caregivers and youth will be informed that participation in the study is voluntary and that all youth who can participate in the NAN program at their agency may do so, regardless of whether they have caregiver consent or provide assent to participate in the research component.
Youth who have caregiver consent, and provide their informed assent to participate, will be enrolled in the study. Using contact information provided to researchers, youth enrolled at all participating agencies will be sent a link by email or text (their preference) to a secure online survey hosted at UNH (Qualtrics). The links will be unique to each youth. Links to surveys will be sent as a text message or email with a generic sounding title (e.g., UNH Teen Survey).
Survey links will be sent to youth at four time points: 1) Prior to any program administration for implementing sites (Baseline survey); 2) Approximately six-weeks after baseline survey administration (and following program administration for implementation site youth) (Six-week follow-up survey); 3) Six months after baseline survey administration (Six month follow-up survey); and 4) Twelve months after baseline survey administration (Twelve-month follow-up survey). Each survey will be designed to take the youth approximately 30 minutes to complete. Youth will be provided with a $20 gift card (e.g., for a locally accessible store like Target or an online store like Amazon) for each survey completed.
Youth from wait-list control condition sites will have the opportunity to receive the NAN program between the six-month and one-year follow-up surveys, providing additional program information on shorter-term outcomes for these youth, while also allowing for longer-term follow-up data on program impact for other youth.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age only
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exposure to the Not a Number Prevention Education Program
The Not a Number (NAN) trafficking prevention program was developed by the non-profit, anti-trafficking program Love 146.
It is an interactive, 5-module curriculum developed for youth ages 12-18, designed to help prevent youth human trafficking and exploitation by: 1) providing information on human trafficking and exploitation; 2) teaching youth to recognize recruitment tactics and understand vulnerability; 3) practicing refusal skills with youth that can help them avoid or reduce risk; 4) identifying healthy support systems; 4) teaching skills to navigate potential and existing exploitative situations; and 5) increasing youth awareness of community helping resources.
The developers worked to integrate components associated with effective prevention programs generally, including varied teaching methods, sufficient dosage, opportunities for positive relationships, and developmental and socio-cultural relevance.
|
The Trafficking Prevention Program involves 5 60 minute lesson modules
|
|
Placebo Comparator: 30 minute Mindfulness Training program
Youth in control condition groups will receive a 30-minute mindfulness training program designed by one of the research staff members.
|
30 minute mindfulness training program for youth designed by research staff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
commercial sexual exploitation victimization
Time Frame: prior six months
|
Measurement of the key outcome of interest is collected via survey questions. A single question was designed to capture the outcome in the survey: ● Have you traded sex or sexual activity for money or other items of value? The item is embedded in a larger scale developed by the team to capture general exposure to commercial sexual exploitation. |
prior six months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UNH-16-FY2023_193-01
- 5 U01CE003406-04-00 (Other Grant/Funding Number: US DHHS, Centers for Disease Control)
- 5U01CE003406-04 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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