Clinical trial NCT01038206: Familias Unidas: Preventing Substance Abuse in Hispanic Youth
Official title: Familias Unidas Stage III Study: Preventing Substance Abuse in Hispanic Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 746
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Substance use will be assessed using items extracted from the Monitoring the Future Study.
timeFrame: Three years
measure: Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument.
timeFrame: Three years
Secondary outcomes:
measure: 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.
timeFrame: Three years
measure: The Family Relations Scale (6 items), completed by adolescent and parent, assess the amount of social support the adolescent receives from the parent
timeFrame: Three years
measure: Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale
timeFrame: Three years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center for Family Studies and Miami-Dade County Public Schools
state: Florida
Study officials:
affiliation: University of Miami
name: Guillermo Prado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.