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NCT03233386 · ClinicalTrials.gov registry record
'Keepin' It REAL in Mexico: An Adaptation and Multisite RCT Implementation of a Substance Abuse Prevention Curriculum for Adolescents in Three Mexico Cities.
A clinical trial, sponsored by Arizona State University.
- Completed
- Registry status
- 5,524
- Enrollment target
NCT03233386 is a clinical trial that has completed, run by Arizona State University. The registered enrollment target is 5,524 participants.
The verdict
NCT03233386 has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- 5,524 participants
- Enrollment target
Study 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 strat
Interventions
- BEHAVIORAL Mantente REAL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,524 participants |
| Start Date | 2015-09-15 |
| Est. Completion | 2019-12-17 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03233386
The ClinicalTrials.gov registry entry for NCT03233386 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 5,524 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mantente REAL is the first listed.
NCT03233386 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03233386 about?
NCT03233386 is a clinical study titled "'Keepin' It REAL in Mexico: An Adaptation and Multisite RCT Implementation of a Substance Abuse Prevention Curriculum for Adolescents in Three Mexico Cities.". 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 gro...
What is the current status of trial NCT03233386?
This trial is currently completed. The enrollment target is 5,524 participants. The study started on 2015-09-15. Estimated completion is 2019-12-17.
What interventions are being tested in trial NCT03233386?
The interventions under investigation include: Mantente REAL (BEHAVIORAL).
Who is sponsoring clinical trial NCT03233386?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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