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

NCT01257022 | Completed Phase 2 DMC

• 1 other identifier: 1R01DA025894-01
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use; Unsafe Sexual Behavior

Keywords

Prevention; HIV; Substance use; Hispanic; Adolescents; Unsafe sexual behavior; Behavioral intervention

Outcome Measures

Primary Outcomes (2)

• Substance use

  Substance use as measured by items similar to those in the Monitoring the Future Survey.

  1 year

• Unsafe sexual behavior

  Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs.

  1 year

Secondary Outcomes (1)

• Family functioning

  1 year

Study Arms (2)

Family Function Intervention

EXPERIMENTAL

Familias Unidas Intervention Program

Behavioral: Familias Unidas

Treatment as Usual

NO INTERVENTION

Control

Interventions

Familias Unidas BEHAVIORAL

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.

Family Function Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Center for Family Studies and Miami-Dade County

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 21969363 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Guillermo Prado, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)