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

• Published in: Contemporary clinical trials Vol. 47; pp. 244 - 253
• Main Authors: Jacobs, Petra, Estrada, Yannine A, Tapia, Maria I, Quevedo Terán, Ana M, Condo Tamayo, Cecilia, Albán García, Mónica, Valenzuela Triviño, Gilda M, Pantin, Hilda, Velazquez, Maria R, Horigian, Viviana E, Alonso, Elizabeth, Prado, Guillermo
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-03-2016
• Subjects: Adolescent; Cardiovascular; Child; Clinical Protocols; Cultural adaptation; Culturally Competent Care; Drugs; Ecuador; Family-based intervention; Feasibility Studies; Female; Follow-Up Studies; Health Promotion - methods; Hematology, Oncology and Palliative Medicine; Hispanic adolescents; Humans; Male; Outcome Assessment (Health Care); Randomized trial; Research Design; Substance-Related Disorders - prevention & control; United States; Unprotected sexual behavior; Unsafe Sex - prevention & control; Drugs; Cultural adaptation; Randomized trial; Unprotected sexual behavior; Family-based intervention; Hispanic adolescents
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2016.01.014

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/design 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. Discussion 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. Trial registration MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador.