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Familias Unidas: Preventing Substance Abuse in Hispanic Youth

2015년 6월 2일 업데이트: Guillermo Prado, University of Miami

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.

연구 개요

상세 설명

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

연구 유형

중재적

등록 (실제)

746

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Florida
      • Miami, Florida, 미국, 33136
        • Center for Family Studies and Miami-Dade County Public Schools

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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. 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Substance use will be assessed using items extracted from the Monitoring the Future Study.
기간: Three years
Three years
Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument.
기간: Three years
Three years

2차 결과 측정

결과 측정
기간
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.
기간: Three years
Three years
The Family Relations Scale (6 items), completed by adolescent and parent, assess the amount of social support the adolescent receives from the parent
기간: Three years
Three years
Parental investment in the adolescent will be assessed using (1) the Parenting Practices (2) the Family Relations scale
기간: Three years
Three years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 8월 1일

기본 완료 (실제)

2014년 6월 1일

연구 완료 (실제)

2014년 6월 1일

연구 등록 날짜

최초 제출

2009년 12월 22일

QC 기준을 충족하는 최초 제출

2009년 12월 22일

처음 게시됨 (추정)

2009년 12월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 6월 2일

마지막으로 확인됨

2015년 6월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Familias Unidas에 대한 임상 시험

3
구독하다