title: Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.
abstract: BACKGROUND
  Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial.
  
  
  METHODS
  Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old.
  
  
  CONCLUSIONS
  The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences.
  
  
  BACKGROUND
  MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador.
authors: Universidad Católica de Santiago de Guayaquil, Av. Carlos Julio Arosemena km. 1 1/2, Guayaquil, Ecuador. Electronic address: petraejacobs@gmail.com.
authors: Petra
authors: P
authors: Jacobs
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: YEstrada@med.miami.edu.
authors: Yannine A
authors: YA
authors: Estrada
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: m.tapia1@med.miami.edu.
authors: Maria I
authors: MI
authors: Tapia
authors: Universidad Católica de Santiago de Guayaquil, Av. Carlos Julio Arosemena km. 1 1/2, Guayaquil, Ecuador. Electronic address: anaquevedo.2012@gmail.com.
authors: Ana M
authors: AM
authors: Quevedo Terán
authors: Universidad Católica de Santiago de Guayaquil, Av. Carlos Julio Arosemena km. 1 1/2, Guayaquil, Ecuador. Electronic address: cecilia.condo@gmail.com.
authors: Cecilia
authors: C
authors: Condo Tamayo
authors: Universidad Católica de Santiago de Guayaquil, Av. Carlos Julio Arosemena km. 1 1/2, Guayaquil, Ecuador. Electronic address: malban59@gmail.com.
authors: Mónica
authors: M
authors: Albán García
authors: Universidad Católica de Santiago de Guayaquil, Av. Carlos Julio Arosemena km. 1 1/2, Guayaquil, Ecuador. Electronic address: gigiv_nena27@yahoo.com.
authors: Gilda M
authors: GM
authors: Valenzuela Triviño
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: HPantin@med.miami.edu.
authors: Hilda
authors: H
authors: Pantin
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: MRVelazquez@med.miami.edu.
authors: Maria R
authors: MR
authors: Velazquez
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: VHorigian@med.miami.edu.
authors: Viviana E
authors: VE
authors: Horigian
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: e.alonso1@med.miami.edu.
authors: Elizabeth
authors: E
authors: Alonso
authors: Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Miami, FL 33136, United States. Electronic address: GPrado@med.miami.edu.
authors: Guillermo
authors: G
authors: Prado
mesh_terms: D000293:Adolescent; D002648:Child; D002985:Clinical Protocols; D065246:Culturally Competent Care; D004484:Ecuador; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D012107:Research Design; D019966:Substance-Related Disorders / Q000517:prevention & control*; D014481:United States; D047568:Unsafe Sex / Q000517:prevention & control*
keywords: Cultural adaptation; Drugs; Family-based intervention; Hispanic adolescents; Randomized trial; Unprotected sexual behavior