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临床试验/NCT02600884
NCT02600884已完成不适用

Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 1,183 人开始时间: 2015年9月1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
1,183
试验地点
2
主要终点
Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents

研究概览

简要总结

The purpose of this research study is to evaluate a brief parent-based adolescent sexual health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an established intervention called Families Talking Together (FTT) and will enhance FTT by adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether FTT will help parents increase sexual health communication, delay adolescent sexual debut, and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be delivered by student nurses.

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
None

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age limit for parents: minimum = N/A (No limit); maximum = N/A (No limit) Age limit for children: minimum = 11 years; maximum = 14 years
  • Inclusion Criteria:
  • Parent: resides with a child 11-14 years old who attends a participating community center, after-school program, or Boys and Girls Club (BGC)
  • Parent: available for a face-to-face or small group session with the PI or student nurse within 2 months of consenting and assenting to participate in the study
  • Parent: can read, write, and speak English or Spanish
  • Child: between 11-14 years of age

排除标准

  • Parent: Without primary custody of child
  • Parent: Incarcerated
  • Parent: Unable to attend a face-to-face session within 2 months

结局指标

主要结局

Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents

时间窗: 1 month

The FTT + HPV survey is a survey that has been developed by the investigator for this study. The survey is administered at baseline, 1, and 6 months using iPads and is available as Audio Computer-Assisted Self-Interviews in both English and Spanish.

Change in intentions for sex as assessed by the FTT + HPV survey administered to youths

时间窗: 6 months

Change in parent child communication as assessed by the FTT + HPV survey administered to parents

时间窗: 6 months

次要结局

  • Change in parental involvement as Assessed by the FTT + HPV survey administered to parents(1 month)
  • Change in parental communication as assessed by the FTT + HPV survey administered to youths(6 months)
  • Change in intentions for communication as assessed by the FTT + HPV survey administered to parents(6 months)
  • Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents(6 months)
  • Change in parental involvement as assessed by the FTT + HPV survey administered to parents(6 months)
  • Change in sexual activity as assessed by the FTT + HPV survey administered to youths(6 months)
  • Change in parental monitoring as assessed by the FTT + HPV survey administered to parents(6 months)
  • Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths(6 months)
  • Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths(6 months)

研究者

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

Diane Santa Maria

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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