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临床试验/NCT00461487
NCT00461487已完成不适用

Reducing Teen Sexual Behavior: A Clinic-Based Approach

Columbia University1 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
530
试验地点
1
主要终点
Incidence of vaginal sexual intercourse measured

研究概览

简要总结

This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.

详细描述

In the United States, racial and ethnic minorities suffer disproportionately from preventable diseases and conditions. Many of these problems result from health-related behaviors that are established during childhood and adolescence. Latino and African-American adolescents are at considerable risk for the negative health consequences of early, risky sexual activity. This study will focus on inner-city Latino and African-American adolescents in grades 6, 7, and 8. The primary aim will be to develop an intervention that parents can use to address the issue of sexual risk behavior with their children.

The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams. Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician. During this time, mothers will receive information about the problem of premature adolescent sexual activity, support in preventing or reducing their children's sexual risk behavior, instruction about how to talk with their children about sexual risk behavior, and targeted homework activities. All parents will also receive three follow-up phone calls to increase the probability that the homework tasks will be completed.

Participants in this study will also be assigned to one of the following three groups: an experimental group; an active control group; or a passive control group. Participants in all groups will complete three questionnaires over the course of the study to assess outcomes. Participants in the experimental and active control groups will partake in an additional meeting with a clinic social worker. Parents in the experimental group will meet with the social worker to discuss effective parent-adolescent communication strategies. They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior. Parents in the active control group will meet with the social worker to discuss adolescent nutrition and receive informational brochures.

Three booster sessions will take place via telephone for parents in the experimental and active control groups. The first booster call will occur approximately 1 month after study entry, the second will occur 5 months after the intervention ends, and the third will occur 9 months post intervention. No such booster calls will be provided to parents in the passive control condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescent must be between the ages of 11 and 14 years old, and in grades 6, 7, or 8
  • Adolescent is able to agree to being a participant
  • Able to participate in questionnaire and intervention activities
  • Latino or African-American descent

排除标准

  • Any cognitive or psychiatric disability that would prevent successful participation in questionnaires and intervention activities

结局指标

主要结局

Incidence of vaginal sexual intercourse measured

时间窗: Measured at Months 3 and 12 post-treatment

次要结局

  • Incidence of condom use(Measured at Months 3 and 12 post-treatment)
  • Incidence of oral sex(Measured at Months 3 and 12 post-treatment)
  • Incidence of anal sex(Measured at Months 3 and 12 post-treatment)
  • Number of sexual partners(Measured at Months 3 and 12 post-treatment)
  • Behavioral intentions(Measured at Months 3 and 12 post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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