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
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01038206
First received: December 22, 2009
Last updated: December 2, 2010
Last verified: September 2010

December 22, 2009
December 2, 2010
August 2010
January 2013   (final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT01038206 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • The Hispanic Stress Inventory (Cervantes, Padilla & Salgado de Snyder, 1991) immigrant version is a 73-item, parent-completed measure that assesses Hispanic parent's stress in 5 different domains. [ Time Frame: Three Years ] [ Designated as safety issue: No ]
  • The Bicultural Involvement Questionnaire- Revised (Szapocznik, Kurtines & Fernandez, 1980) is a 42-item self-report measure completed by both adolescents and parents. [ Time Frame: Three years ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Familias Unidas: Preventing Substance Abuse in Hispanic Youth
Familias Unidas Stage III Study: Preventing Substance Abuse in Hispanic Youth

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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Prevention
  • Family Function
  • Substance Use
  • Sexual Behavior
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.
  • Experimental: Family Function Intervention
    Familias Unidas Intervention Program
    Intervention: Behavioral: Familias Unidas
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1512
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
12 Years and older
Yes
Contact: Guillermo Prado, PhD 305-243-2748 GPrado@med.miami.edu
Contact: Maria Tapia, M.S.W. 305-243-2341 MTapia@med.miami.edu
United States
 
NCT01038206
DA025192-01A1
Yes
Tom Gill, Director Research Administration, University of Miami
University of Miami
Not Provided
Principal Investigator: Guillermo Prado, PhD University of Miami
University of Miami
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP