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临床试验/NCT01326806
NCT01326806已完成不适用

Reducing Teen Sexual Behavior: A Clinic-Based Approach

New York University1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2012年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,800
试验地点
1
主要终点
Incidence of condom use

研究概览

简要总结

The purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. The intervention will be administered in the context of mothers waiting for their children to complete a non-acute care visit.

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 consequences of early, risky sexual activity. This study will focus on Latino and African-American early adolescents ages 11 to 14.

The primary aim for this study will be to test and refine a triadic intervention developed for healthcare providers and parents to address the issue of sexual risk behavior among African American and Latino adolescents.

The triadic intervention will take place in a pediatric health care clinic when mothers accompany their children for a non-acute care visit. Mothers will meet with a provider extender (medical assistant, social worker, counselor) for approximately 30 minutes while their children are being examined by a healthcare provider. 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. The healthcare provider will endorse the intervention separately for mothers and adolescents. All parents will also receive one follow-up phone call 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 intervention session with a provider extender. Parents in the experimental group will meet with the provider extender 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 provider extender to discuss adolescent nutrition and receive informational brochures.

One booster session will take place via telephone for parents in the experimental and active control groups. The booster call will occur approximately 1 month after study entry. 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
主要目的
Prevention
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

  • Adolescents must be between the ages of 11 and 14 years old
  • Adolescent is able to agree to being a participant
  • Participant must be able to participate in questionnaire and intervention activities
  • Participant must be of Latino or African American descent

排除标准

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

结局指标

主要结局

Incidence of condom use

时间窗: Measured at 12-months post-intervention

Incidence of vaginal intercourse

时间窗: Measured at 12 months post-intervention

次要结局

  • Number of sexual partners(Measured at 3 months post-intervention)
  • Incidence of condom use(Measured at 3 months post-intervention)
  • Behavioral intentions(Measured at 3 months post-intervention)
  • Incidence of vaginal intercourse(Measured at 3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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