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临床试验/NCT04501471
NCT04501471已完成2 期

The Rural African American's Health Project

University of Georgia0 个研究点目标入组 502 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
502
主要终点
Substance Use

研究概览

简要总结

This is an attention controlled randomized clinical trial testing the efficacy of the Strong African American Families-Teen program. The two arm trial tests SAAF-T, a family centered brief intervention against a similarly designed program that targets nutrition and exercise. The outcomes examined include substance use and risky sexual behavior.

详细描述

In the past, African American adolescents in rural areas have avoided the high-risk behaviors prevalent among youth in urban areas. Recent epidemiologic data, however, indicate that rural African American youth use substances and engage in high-risk sexual behavior at rates equal to or exceeding those in densely populated inner cities (Kogan, Berkel, Chen, Brody, & Murry, in press; Milhausen et al., 2003). These risk behaviors predict HIV infection, adolescent parenthood, school dropout, involvement with the criminal justice system, and continued substance use during early adulthood (Friedman et al., 1996; Miller, Boyer, & Cotton, 2004; St. Lawrence & Scott, 1996; Tucker, Orlando, & Ellickson, 2003). No developmentally appropriate, culturally sensitive prevention programs have been developed to deter substance use and high-risk sexual behavior among the several million African American adolescents who live in the rural South (Murry & Brody, 2004). To address this public health need, Drs. Brody and Murry from the University of Georgia and Drs. DiClemente and Wingood from Emory University designed a multicomponent, family-centered prevention program, the Strong African American Families-Teen program (SAAF-T). We conducted a randomized prevention trial to test the program's efficacy. The sample included 502 rural African American families with a 10th-grade student, half of whom will be assigned randomly to a prevention group and half to an attention-control group. Pre-intervention, post-intervention, and long-term follow-up assessments of adolescents' substance use and high-risk sexual behavior were gathered from the entire sample. Specific aims were to test hypotheses that rural African American adolescents randomly assigned to participate in SAAF-T, compared to attention-control participants, will demonstrate lower rates of substance use and risky sexual behavior.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Participants and providers were not aware that the Fuel condition was considered an attention control

入排标准

年龄范围
15 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Self-identified Black or African American
  • 10th grade in public school in targeted county

排除标准

  • Unable to participate in group-based intervention due to mental health

结局指标

主要结局

Substance Use

时间窗: Follow up period baseline to 22 months post-baseline

Index of alcohol, cigarette, and marijuana use in the past 3 months

Risky Sexual Behavior

时间窗: Follow up period baseline to 22 months post-baseline

Count of unprotected intercourse

次要结局

  • Conduct Problems(Follow up period baseline to 22 months post-baseline)
  • Depressive symptomology- CES-D Scale(Symptoms in past week assessed, follow up period includes baseline to 22 months post baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gene H. Brody

Regents Professor

University of Georgia

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