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Набор скоро начнётся NCT07503912

Evaluation of the Not A Number Trafficking Prevention Program in Minnesota

Без фазы С лечением Commercial Sexual Exploitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Trafficking Prevention Education for Youth, Mindfulness Training.
Кому может быть актуально
Состояния в реестре: Commercial Sexual Exploitation. Базовые параметры: 13 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Randomized Controlled Trial Evaluation of the Not A Number Trafficking Prevention Program in MN

Обзор

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).

Подробное описание

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.

Вмешательства

  • Поведенческое Trafficking Prevention Education for Youth
    The Trafficking Prevention Program involves 5 60 minute lesson modules
  • Поведенческое Mindfulness Training
    30 minute mindfulness training program for youth designed by research staff

Первичные конечные точки

  • commercial sexual exploitation victimization [Срок оценки: prior six months]

Критерии участия

Критерии включения

  • Age only

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07503912 · UNH-16-FY2023_193-01 · 5 U01CE003406-04-00 · 5U01CE003406-04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗