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Familias Unidas: Preventing Drug Abuse and HIV in Hispanic First Offenders

Primary Purpose

Substance Use, Unsafe Sexual Behavior

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 Substance Use focused on measuring Prevention, HIV, Substance use, Hispanic, Adolescents, Unsafe sexual behavior, Behavioral intervention

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish-speaking country of the Americas
  2. First-time offenders or Hispanic adolescents, identified by Miami Dade County Public Schools as exhibiting Level III behaviors which include: assault/threat against a non-staff member, breaking and entering/burglary, fighting (serious), hazing, possession or use of alcohol and/or controlled substances, possession of simulated weapons, trespassing, and vandalism.
  3. Adolescents between 12 and 17 years of age
  4. Adolescents living with an adult primary caregiver who is willing to participate

Exclusion Criteria:

(a) Family reports to have (tentative or firm) plans to move out of the South Florida area during the year of the study

Sites / Locations

  • Center for Family Studies and Miami-Dade County

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

Control

Outcomes

Primary Outcome Measures

Substance use
Substance use as measured by items similar to those in the Monitoring the Future Survey.
Unsafe sexual behavior
Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs.

Secondary Outcome Measures

Family functioning

Full Information

First Posted
December 8, 2010
Last Updated
March 4, 2014
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01257022
Brief Title
Familias Unidas: Preventing Drug Abuse and HIV in Hispanic First Offenders
Official Title
Preventing Drug Abuse and HIV in Hispanic First Offenders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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 main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United Families), a family-based, ecodevelopmental intervention found to be previously efficacious in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al., 2007). The study hypotheses are as follows: Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing drug use among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time. Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by improvements in family functioning. Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time. Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially mediated by improvements in family functioning. Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing subsequent criminal offenses among Hispanic first offending adolescents or in preventing a first time offense for those at risk for committing a first time offense over time. Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be mediated by family functioning.
Detailed Description
Familias Unidas aims to prevent drug use and unprotected sexual behavior by increasing family functioning. A sample of 240 Hispanic adolescent first offenders or those at risk of becoming first offenders (age range 12 to 17) and 240 primary caregivers will be randomized to one of two conditions: Familias Unidas or Treatment as Usual. The investigators do not expect any risks to participants for participating in this study; however, participants may feel embarrassed by some of the content or feel fatigued as a result of completing the assessments. Also, depending on which group participants are assigned to, they may be less likely to use drugs and practice unsafe sexual behaviors and more likely to function better as families. The proposed study will be guided by four aims. AIM 1 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing illicit drug use in a sample of Hispanic youth first offenders or those at high risk of committing a first offense; AIM 2 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing unsafe sexual behavior; AIM 3 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing a first offense or reducing the number of subsequent criminal offenses ; and AIM 4 is to assess the extent to which family functioning mediates the effects of the intervention on illicit drug use, unsafe sexual behavior, and first or subsequent criminal offenses. Compared to non-Hispanic whites, Hispanic adolescents are highly vulnerable to drug use and HIV infection. Hispanic adolescents between the ages of 13 to 19 are five times more likely to be infected with HIV than are same-aged non-Hispanic Whites (CDC-P, 2006). Compared to non-Hispanic whites and to African Americans, Hispanic 8th graders report the highest lifetime, annual, and 30-day prevalence rates of alcohol, cigarette, and licit or illicit drug use (with the exception of amphetamines; Johnston et al., 2008). Hispanic adolescents also have higher rates of unprotected sex at last intercourse (CDC-P, 2007) than non-Hispanic whites or African Americans. Drug use and unsafe sexual behavior are risks for HIV infection. Hispanics are also a youthful population, with more than one-third under the age of 18 (Marotta & Garcia, 2003). Preventing drug use and HIV in Hispanics, and particularly among Hispanic youth at elevated risk for drug use and unsafe sexual behavior, such as Hispanics in the criminal justice setting or those at risk of entering the criminal justice system (Telpin, 2003), is therefore of vital importance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Unsafe Sexual Behavior
Keywords
Prevention, HIV, Substance use, Hispanic, Adolescents, Unsafe sexual behavior, Behavioral intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
242 (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
Control
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.
Primary Outcome Measure Information:
Title
Substance use
Description
Substance use as measured by items similar to those in the Monitoring the Future Survey.
Time Frame
1 year
Title
Unsafe sexual behavior
Description
Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Family functioning
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish-speaking country of the Americas First-time offenders or Hispanic adolescents, identified by Miami Dade County Public Schools as exhibiting Level III behaviors which include: assault/threat against a non-staff member, breaking and entering/burglary, fighting (serious), hazing, possession or use of alcohol and/or controlled substances, possession of simulated weapons, trespassing, and vandalism. Adolescents between 12 and 17 years of age Adolescents living with an adult primary caregiver who is willing to participate Exclusion Criteria: (a) Family reports to have (tentative or firm) plans to move out of the South Florida area during the year of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Family Studies and Miami-Dade County
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21969363
Citation
Prado G, Pantin H, Huang S, Cordova D, Tapia MI, Velazquez MR, Calfee M, Malcolm S, Arzon M, Villamar J, Jimenez GL, Cano N, Brown CH, Estrada Y. Effects of a family intervention in reducing HIV risk behaviors among high-risk Hispanic adolescents: a randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Feb;166(2):127-33. doi: 10.1001/archpediatrics.2011.189. Epub 2011 Oct 3.
Results Reference
derived

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Familias Unidas: Preventing Drug Abuse and HIV in Hispanic First Offenders

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