'Keepin' It REAL in Mexico: An Adaptation and Multisite RCT Implementation of a Substance Abuse Prevention Curriculum for Adolescents in Three Mexico Cities.

NCT03233386 | Completed DMC

• 1 other identifier: 1095
• Study Type: observational
• Target: 5,524
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (3)

• Adapt kiR

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

  month 1-18

• Efficacy trial using the Mantente REAL Mexican Youth Survey

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

  month 19-54

• Gender role norms using the Mantente REAL Mexican Youth Survey

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

  month 25-60

Secondary Outcomes (1)

• Adolescent vulnerability to violence using the Mantente REAL Mexican Youth Survey

  month 25-60

Study Arms (3)

Condition 1

Mexico City Cohort

Behavioral: Mantente REAL

Condition 2

Monterrey Cohort

Behavioral: Mantente REAL

Condition 3

Guadalajara Cohort

Behavioral: Mantente REAL

Interventions

Mantente REAL BEHAVIORAL

substance abuse prevention curriculum for adolescents

Condition 1; Condition 2; Condition 3

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

adolescents ages 10-17

You may qualify if:

• all students enrolled in participating class rooms

You may not qualify if:

• n/a

Sponsors & Collaborators

• Arizona State University: lead
• Universidad Autonoma de Nuevo Leon: collaborator
• Instituto Nacional Psiquiatrico de México - Ciudad de México: collaborator
• Instituto Milton Erickson Guadalajara: collaborator

Study Sites (1)

Center for International Translational Intervention Research

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• Kulis SS, Marsiglia FF, Medina-Mora ME, Nuno-Gutierrez BL, Corona MD, Ayers SL. Keepin' It REAL-Mantente REAL in Mexico: a Cluster Randomized Controlled Trial of a Culturally Adapted Substance Use Prevention Curriculum for Early Adolescents. Prev Sci. 2021 Jul;22(5):645-657. doi: 10.1007/s11121-021-01217-8. Epub 2021 Mar 26.

  PMID: 33772435 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents' Professor and CITIR Director

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 28, 2017
• Study Start: September 15, 2015
• Primary Completion: November 28, 2019
• Study Completion: December 17, 2019
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will become available following publication of all manuscripts reporting outcomes of primary and secondary aims. It is anticipated that these data will be available beginning year 7 and for 7 years following.
• Access Criteria: Access criteria are identified in the plan to share IPD.

Locations

US (1)