Familias Unidas: Preventing Substance Abuse in Hispanic Youth
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Miami.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Miami
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01038206
First received: December 22, 2009
Last updated: December 2, 2010
Last verified: September 2010
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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: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038206
Contacts
| Contact: Guillermo Prado, PhD | 305-243-2748 | GPrado@med.miami.edu |
| Contact: Maria Tapia, M.S.W. | 305-243-2341 | MTapia@med.miami.edu |
Locations
| United States, Florida | |
| Center for Family Studies and Miami-Dade County Public Schools | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Guillermo Prado, PhD 305-243-2478 gprado@med.miami.edu | |
| Principal Investigator: Guillermo Prado, PhD | |
Sponsors and Collaborators
University of Miami
Investigators
| Principal Investigator: | Guillermo Prado, PhD | University of Miami |
More Information
No publications provided
| Responsible Party: | Tom Gill, Director Research Administration, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01038206 History of Changes |
| Other Study ID Numbers: | DA025192-01A1 |
| Study First Received: | December 22, 2009 |
| Last Updated: | December 2, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on March 14, 2013
