Familias Unidas: Preventing Substance Abuse in Hispanic Youth
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|ClinicalTrials.gov Identifier: NCT01038206|
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : June 3, 2015
The focus of this study will be to test the Familias Unidas Intervention program among Hispanic 8th graders in the Miami-Dade County Public School System. This study will contribute to the advancement of knowledge in both the scientific community and the Hispanic population in Miami-Dade County. It will shed light on whether and to what extent Familias Unidas is effective in preventing drug use and unsafe sexual behavior in Hispanic adolescents. To the scientific community, the investigators will disseminate our findings via peer-reviewed publications and presentations at scientific meetings.
The design for the proposed study is a randomized controlled trial. This design is considered the "gold standard" design when evaluating the efficacy of two (or more) treatment conditions. Participants for this study will be 744 Hispanic 8th grade adolescents and their parents recruited from 24 randomly selected middle schools in Miami Dade County that meet the school inclusion/exclusion criteria. A total of 12 schools (for a total of 372 Hispanic adolescents and their parents) will be randomized to Familias Unidas and a total of 12 schools (for a total of 372 Hispanic adolescents and their parents) will be randomized to the Community Practice.
|Condition or disease||Intervention/treatment||Phase|
|Prevention Family Function Substance Use Sexual Behavior||Behavioral: Familias Unidas||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||746 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Familias Unidas Stage III Study: Preventing Substance Abuse in Hispanic Youth|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Family Function Intervention
Familias Unidas Intervention Program
Behavioral: Familias Unidas
There will be 8 group sessions and 4 family visits. During the group sessions, the facilitator offers support for parents and gently corrects maladaptive interactions between parents and adolescents. During family visits, facilitators assist families in practicing skills and restructuring family interactions. The parent group sessions focus on parental investment in the adolescent's worlds (e.g., peer and school worlds), family communication, family support, behavior management/positive parenting, parental monitoring, adolescent substance use, and adolescent unsafe sex and HIV. Consistent with our prior Familias Unidas efficacy studies, all parent group sessions and all family visits will be conducted in Spanish and will take place in the evenings and on Saturdays at the school or at a community site that is preferred by the families.
No Intervention: Treatment as Usual
The Public School system mandates that all high school students receive at least 5 lessons (55 minutes each) per year of HIV prevention.
- Substance use will be assessed using items extracted from the Monitoring the Future Study. [ Time Frame: Three years ]
- Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument. [ Time Frame: Three years ]
- Two subscales of the Parenting Practices: (a) extent of parental involvement (including involvement in school related activities) and (b) positive parenting will be used to assess parental investment. [ Time Frame: Three years ]
- The Family Relations Scale (6 items), completed by adolescent and parent, assess the amount of social support the adolescent receives from the parent [ Time Frame: Three years ]
- Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale [ Time Frame: Three years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038206
|United States, Florida|
|Center for Family Studies and Miami-Dade County Public Schools|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Guillermo Prado, PhD||University of Miami|