Familias Unidas: Preventing Substance Abuse in Hispanic Youth

NCT01038206 | Completed Phase 2 DMC

• 1 other identifier: DA025192-01A1
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prevention; Family Function; Substance Use; Sexual Behavior

Keywords

prevention; HIV; drugs; smoking; Hispanic; Adolescent; Familias Unidas; Parent-Preadolescent Training; parent-centered; unsafe sexual behavior; efficacy; intervention

Outcome Measures

Primary Outcomes (2)

• Substance use will be assessed using items extracted from the Monitoring the Future Study.

  Three years

• Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument.

  Three years

Secondary Outcomes (3)

• 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.

  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

  Three years

• Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale

  Three years

Study Arms (2)

Family Function Intervention

EXPERIMENTAL

Familias Unidas Intervention Program

Behavioral: Familias Unidas

Treatment as Usual

NO INTERVENTION

The Public School system mandates that all high school students receive at least 5 lessons (55 minutes each) per year of HIV prevention.

Interventions

Familias Unidas BEHAVIORAL

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.

Family Function Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male adolescents of Hispanic immigrant origin, defined by the Primary caregiver as Self-identified Hispanic.
• Adolescents attending 8th grade at baseline
• Adolescents living with an adult primary caregiver who is willing to participate
• At baseline, families must live within the catchment areas of the 24 participating middle schools

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Center for Family Studies and Miami-Dade County Public Schools

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Lee TK, Estrada Y, Soares MH, Sanchez Ahumada M, Correa Molina M, Bahamon MM, Prado G. Efficacy of a Family-Based Intervention on Parent-Adolescent Discrepancies in Positive Parenting and Substance Use Among Hispanic Youth. J Adolesc Health. 2019 Apr;64(4):494-501. doi: 10.1016/j.jadohealth.2018.10.002. Epub 2018 Dec 1.

  PMID: 30514652 DERIVED

• Estrada Y, Lee TK, Huang S, Tapia MI, Velazquez MR, Martinez MJ, Pantin H, Ocasio MA, Vidot DC, Molleda L, Villamar J, Stepanenko BA, Brown CH, Prado G. Parent-Centered Prevention of Risky Behaviors Among Hispanic Youths in Florida. Am J Public Health. 2017 Apr;107(4):607-613. doi: 10.2105/AJPH.2017.303653. Epub 2017 Feb 16.

  PMID: 28207330 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Sexual Behavior; Smoking

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Guillermo Prado, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: August 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)