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

4 mars 2014 uppdaterad av: Guillermo Prado, University of Miami

Preventing Drug Abuse and HIV in Hispanic First Offenders

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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

242

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Florida
      • Miami, Florida, Förenta staterna, 33136
        • Center for Family Studies and Miami-Dade County

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 17 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Family Function Intervention
Familias Unidas Intervention Program
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.
Inget ingripande: Treatment as Usual
Control

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Substance use
Tidsram: 1 year
Substance use as measured by items similar to those in the Monitoring the Future Survey.
1 year
Unsafe sexual behavior
Tidsram: 1 year
Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs.
1 year

Sekundära resultatmått

Resultatmått
Tidsram
Family functioning
Tidsram: 1 year
1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Guillermo Prado, Ph.D., University of Miami

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2009

Primärt slutförande (Faktisk)

1 april 2011

Avslutad studie (Faktisk)

1 april 2011

Studieregistreringsdatum

Först inskickad

8 december 2010

Först inskickad som uppfyllde QC-kriterierna

8 december 2010

Första postat (Uppskatta)

9 december 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 mars 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 mars 2014

Senast verifierad

1 mars 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 1R01DA025894-01 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Substansanvändning

Kliniska prövningar på Familias Unidas

  • Medicrea International
    Avslutad
    Spinal krökningar | Idiopatisk skolios | Spondylolistes | Degenerativ skolios
    Frankrike, Belgien, Polen
  • Medicrea, USA Corp.
    Indragen
    Degenerativ disksjukdom | Spinal stenos | Spinal Fusion | Kyfoskolios | Skolios; Ungdom | Pseudoartros i ryggraden | Kyphoses, Scheuermann
  • Medicrea International
    Avslutad
    Spondylos | Spinala neoplasmer | Ryggmärgskompression | Ossifikation av bakre longitudinella ligament | Bensjukdom, smittsam
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3
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