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临床试验/NCT03233386
NCT03233386已完成不适用

'Keepin' It REAL in Mexico: An Adaptation and Multisite RCT

Arizona State University1 个研究点 分布在 1 个国家目标入组 5,524 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,524
试验地点
1
主要终点
Adapt kiR

研究概览

简要总结

Sharp increases in substance use rates among youth in Mexico are a major concern, both in Mexico and the US. Although the Mexican government has elevated substance abuse prevention as a national priority, there are few school-based universal prevention programs to choose from that are culturally grounded, empirically tested, and shown to be efficacious. This study aims to address this gap by adapting, implementing, and testing the keepin' it REAL (kiR) prevention intervention in Mexico's three largest cities: Mexico City, Guadalajara, and Monterrey. kiR is a model program for middle school students on the US National Registry of Effective Programs and Practices, shown to be efficacious and cost-effective in reducing substance use among large multi-ethnic and Mexican American samples in the US. The proposed study will leverage the bi-national research team's expertise in developing and adapting kiR and build upon a series of feasibility studies across Mexico which showed that kiR's core elements are applicable there. However, evidence also suggested that further adaptation is needed to enhance the intervention's cultural fit. During the proposed study's Phase 1, students and teacher-implementers in three schools-one from each of the cities-will provide feedback about the original curriculum and identify culturally and contextually relevant scenarios and examples. The bi-national research team-including original kiR curriculum designers-will collaborate to ensure cultural applicability in Mexico and fidelity to core elements of kiR. In Phase 2, the efficacy of the culturally adapted Mexican version of kiR, relative to the original version of kiR and to a control condition, will be tested through an intent-to-treat analysis in a randomized controlled trial with 7,768 7th grade students in 36 middle schools, 12 from each city. The study will investigate and incorporate into the curriculum gender specific experiences with drug offers and appropriate drug resistance strategies in the Mexican context that may impact the youths' risk of substance use and their responsiveness to prevention programs. In light of rising violence in Mexico, a secondary aim of the study is to investigate how youths' perpetration, victimization, and witnessing of violence may moderate the efficacy of kiR in Mexico. The study will create knowledge relevant to efficacious prevention approaches for Mexican-heritage youth on both sides of the US-Mexico border. Prevention science will be advanced by understanding how culturally influenced gender norms affect substance use offers, attitudes, and behaviors, as well as the success of universal prevention programs. In addition, the study will add to knowledge on how to execute collaborative, cross-national, translational prevention intervention research.

详细描述

The need for more effective prevention efforts in Mexico is clear and increasingly urgent, with important ramifications for the US. In the US immigrant adolescents from Mexico historically have had lower drug use rates than US-born Mexican Americans, but these trends are changing rapidly. To fill the gap in evidence-based universal prevention programs in Mexico, this study proposes to adapt, implement, and test the efficacy of kiR-a school-based substance use prevention program in use in the US and several other countries-among a sample of youth from the three largest urban areas in Mexico. This study will directly impact factors influencing sustainability - leadership, capacity, and relationship building. The research team is partnering with Dr. Medina-Mora and the National Psychiatric Institute of Mexico, which oversees substance use prevention nationwide. This study will build long-term relationships with Mexican scientists, educators, government agencies, social workers, and community stakeholders; demonstrate the feasibility of coordinated strategies for implementing school-based prevention programs involving national and local stakeholders; and will increase the capacity of schools and communities to deliver future interventions to additional students.

keepin' it REAL (kiR), a SAMHSA recognized model program on the National Registry of Effective Programs and Practices (NREPP), is a school-based, manualized curriculum for substance use prevention among middle school students. The kiR curriculum includes: 10 weekly classroom lessons; 5 videos demonstrating drug resistance strategies that were scripted, acted and filmed by students; and school-wide booster activities (e.g., replaying the videos) to reinforce the classroom lessons. The curriculum is implemented by regular classroom teachers who receive a two-day long training.

The curriculum includes the mix of elements found to have the largest effect sizes in school-based prevention interventions: those that teach comprehensive life skills to increase knowledge of substance use, address affective and motivational aspects of substance use (e.g., anti-drug attitudes, beliefs and values) and build risk assessment, decision making, and drug refusal skills. kiR emphasizes the mastery and expansion of a repertoire of the drug resistance strategies most commonly and effectively employed by adolescents: to refuse substance offers with a simple "no", to explain or provide an excuse to decline the offer; to avoid situations where substances might be offered; and to leave when substances are offered. kiR teaches a variety of communication techniques to reject risky or undesirable influences, and the flexibility to select appropriately from a repertoire of strategies in different situations. Youths equipped with multiple strategies can assess situations where substances are offered, decide which resistance strategies will be most effective, and try additional strategies (repertoire) if the first one does not work.

There are several reasons the original kiR curriculum is an appropriate foundation for developing efficacious school-based prevention approaches in Mexico: its attention to Mexican American cultural and social contexts of substance use; evidence of the applicability of kiR's core components in Mexico; and its ideal developmental timing for implementation. There are also theoretical and empirical reasons that additional adaptation to the cultural and social contexts of Mexico is needed. The cultural communication patterns of youth and the context of substance use offers needs to be incorporated when adapting it for use in Mexico.

Cross-sectional studies in Mexico show that kiR's core elements and approach are relevant and effective for Mexican youth from different regions. Surveys of Mexican high school youth found that kiR strategies were not only used in Monterrey and in Guanajuato State, but that the use of these strategies is associated with decreased alcohol and tobacco use. A longitudinal randomized pilot field trial of kiR in two Guadalajara middle schools reported significant effects in reducing use of alcohol, cigarette, and marijuana use, but in ways that differed for males and females, suggesting that additional tailoring of the curriculum to gendered substance use cultural and social contexts may be needed.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • all students enrolled in participating class rooms

排除标准

  • 未提供

结局指标

主要结局

Adapt kiR

时间窗: month 1-18

Report the effectiveness of the adapted keepin' it REAL curriculum.

Efficacy trial using the Mantente REAL Mexican Youth Survey

时间窗: month 19-54

To report the efficacy of the adapted version of keepin' it REAL in three metropolitan areas in Mexico.

Gender role norms using the Mantente REAL Mexican Youth Survey

时间窗: month 25-60

Report how traditional gender role norms in Mexico moderate the efficacy of keepin' it REAL.

次要结局

  • Adolescent vulnerability to violence using the Mantente REAL Mexican Youth Survey(month 25-60)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavio Marsiglia

Regents' Professor and CITIR Director

Arizona State University

研究点 (1)

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