Familias Unidas: Preventing Substance Abuse in Hispanic Youth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guillermo Prado, University of Miami
ClinicalTrials.gov Identifier:
NCT01038206
First received: December 22, 2009
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Prevention
Family Function
Substance Use
Sexual Behavior
Behavioral: Familias Unidas
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Familias Unidas Stage III Study: Preventing Substance Abuse in Hispanic Youth

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Substance use will be assessed using items extracted from the Monitoring the Future Study. [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1512
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038206

Locations
United States, Florida
Center for Family Studies and Miami-Dade County Public Schools
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Guillermo Prado, PhD University of Miami
  More Information

No publications provided

Responsible Party: Guillermo Prado, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01038206     History of Changes
Other Study ID Numbers: DA025192-01A1
Study First Received: December 22, 2009
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
prevention
HIV
drugs
smoking
Hispanic
Adolescent
Familias Unidas
Parent-Preadolescent Training
parent-centered
unsafe sexual behavior
efficacy
intervention

ClinicalTrials.gov processed this record on October 19, 2014