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Familias Unidas: Preventing Substance Abuse in Hispanic Youth

Primary Purpose

Prevention, Family Function, Substance Use

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Familias Unidas
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention focused on measuring prevention, HIV, drugs, smoking, Hispanic, Adolescent, Familias Unidas, Parent-Preadolescent Training, parent-centered, unsafe sexual behavior, efficacy, intervention

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Family Studies and Miami-Dade County Public Schools

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family Function Intervention

Treatment as Usual

Arm Description

Familias Unidas Intervention Program

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

Outcomes

Primary Outcome Measures

Substance use will be assessed using items extracted from the Monitoring the Future Study.
Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument.

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.
The Family Relations Scale (6 items), completed by adolescent and parent, assess the amount of social support the adolescent receives from the parent
Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale

Full Information

First Posted
December 22, 2009
Last Updated
June 2, 2015
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01038206
Brief Title
Familias Unidas: Preventing Substance Abuse in Hispanic Youth
Official Title
Familias Unidas Stage III Study: Preventing Substance Abuse in Hispanic Youth
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Substance use (including cigarette and illicit drug use) and HIV represent major public health problems facing America's youth (CDC, 2007; Johnston, O'Malley, Bachman, & Schulenberg, 2007). Hispanic adolescents report higher use across all drug categories (with the exception of amphetamines) and higher cigarette use than non-Hispanic White and African American adolescents (Johnston et al., 2007). Hispanic youth also engage in higher rates of unprotected sexual behavior at last sexual intercourse than non-Hispanic White and African American adolescents (CDC, 2007). Compared to non-Hispanic Whites, Hispanics are also disproportionately represented among HIV/AIDS cases, accounting for 18% if all such cases in the United States (CDC, 2006). These disparities are especially disconcerting because Hispanics are the largest and fastest growing minority group in the United States (Marotta & Garcia, 2003). Preventing substance use and HIV in Hispanic adolescents is therefore if vital importance. Familias Unidas is delivered through family-centered, multi-parent groups that place parents in the change agent role and through family visits. Each parenting skill is discussed and role-played in parent-group sessions and is then enacted with the parent and the adolescent in a family visit. During the group sessions, the facilitator offers support for parents and gently corrects maladaptive interactions between parents and adolescents (during the group-session role plays, the role of adolescent is played by another parent). 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. The proposed study will be guided by four aims. AIM 1 is to evaluate the effectiveness of Familias Unidas, relative to Community Practice (i.e., standard prevention services), in preventing illicit drug use in a community sample of Hispanic adolescents; AIM 2 is to evaluate the effectiveness of Familias Unidas, relative to Community Practice in preventing cigarette use in a community sample of Hispanic adolescents; AIM 3 is to evaluate the effectiveness of Familias Unidas, relative to Community Practice, in preventing unsafe sexual behavior in a community sample of Hispanic adolescents; and AIM 4 is to assess the extent to which family functioning mediates the effects of the intervention on illicit drug use, cigarette use, and unprotected sexual behavior. Hypothesis 1. Familias Unidas will be more effective than Community Practice in reducing adolescent illicit drug use (defined as frequency of illicit drug use in the past 90 days) over time. Hypothesis 1a. The effect of Familias Unidas on illicit drug use will be partially mediated by improvements in family functioning, defined as parental involvement, parental monitoring of peers, parent-adolescent communication, social support, and positive parenting. Hypothesis 2. Familias Unidas will be more effective than Community Practice in reducing cigarette use (defined as frequency of cigarette use in the past 90 days) over time. Hypothesis 2a. The effect of Familias Unidas on cigarette use will be partially mediated by improvements in family functioning, defined as parental involvement, parental monitoring of peers, parent-adolescent communication, family support, and positive parenting. Hypothesis 3. Familias Unidas will be more effective than Community Practice in reducing unsafe sexual behavior (defined as unprotected sexual behavior at last sexual intercourse) over time. Hypothesis 3a. The effect of Familias Unidas on unsafe sexual behavior will be partially mediated by improvement in family functioning, defined as parental involvement, parental monitoring of peers, parent-adolescent communication, family support, and positive parenting. Inclusion/Exclusion criteria a) Female and male adolescents of Hispanic origin, defined as self-identified Hispanic by the Primary caregiver. (b) Adolescents attending 8th grade at baseline (c) Adolescents living with an adult primary caregiver who is willing to participate (d) At baseline, families must live within the catchment areas of the 24 participating middle schools

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Function Intervention
Arm Type
Experimental
Arm Description
Familias Unidas Intervention Program
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
The Public School system mandates that all high school students receive at least 5 lessons (55 minutes each) per year of HIV prevention.
Intervention Type
Behavioral
Intervention Name(s)
Familias Unidas
Intervention Description
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.
Primary Outcome Measure Information:
Title
Substance use will be assessed using items extracted from the Monitoring the Future Study.
Time Frame
Three years
Title
Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Family Studies and Miami-Dade County Public Schools
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30514652
Citation
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.
Results Reference
derived
PubMed Identifier
28207330
Citation
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.
Results Reference
derived

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Familias Unidas: Preventing Substance Abuse in Hispanic Youth

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