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临床试验/NCT01432756
NCT01432756已完成不适用

A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2011年9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
132
试验地点
2
主要终点
Number of Topics Discussed Between Parent and Child

研究概览

简要总结

The investigators hypothesize that participants in the worksite parenting program intervention will show significantly better parent-child communication than will participants in the no-treatment (wait-list) control group.

详细描述

In South Africa, >5 million people, including many adolescents, are living with HIV. Prevalence is increasing throughout South Africa, most precipitously in the Western Cape, the site of our proposed study. The investigators propose to pilot test a multisession worksite-based program to help parents learn how to take an active role in rearing sexually healthy youth. Our specific aims are to: (1) Culturally adapt our US-developed worksite-based program for parents of adolescents to the South African context; (2) Examine whether a worksite-based program for parents of adolescents in South Africa improves the parent-child relationship, including general parent-child communication and communication about sexual health and HIV risk-reduction, as perceived by parents and adolescents; (3) Explore program effects on parents' HIV testing and sexual behaviors; and (4) Explore program effects on theoretically important psychosocial mediators of behavior change (e.g., greater self-efficacy for refusing sex and using condoms, and more perceived disadvantages of unprotected sex). The proposed research is a unique opportunity to adapt and pilot test an innovative HIV prevention intervention that promotes the health of families in a culturally acceptable and sustainable setting.

The research is being conducted in three phases. In Phase 1, the investigators conducted formative qualitative interviews with South African community members who work with adolescents and parents, who work on HIV prevention, and who hold relevant positions at worksites. The investigators used this information from key community members to culturally adapt the program. In Phase 2, the investigators are conducting a process evaluation of one intervention group of 15 parents using qualitative debriefing interviews and quantitative data. In Phase 3, the current phase, the investigators aim to conduct a pilot intervention to refine the program even further and test the evaluation methods with 60 Xhosa and Afrikaans-speaking parents and their 11-15-year-old adolescents (who will participate in the evaluation but not the program). Their outcomes will be compared to a wait-list control group of 60 Xhosa and Afrikaans-speaking parents and their 11-15-year-old adolescents.

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 (Investigator)

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

  • Parents: Work for City of Cape Town; Are Xhosa-speaking or Afrikaans-speaking; Have a child between the ages of 11-15 (self report); Spend at least 3 days/week with their adolescents
  • Children: Eligible if they are between the ages of 11-15 (self report) and have a parent or legal guardian who works in the City of Cape Town who is enrolled in the program.

排除标准

  • 未提供

结局指标

主要结局

Number of Topics Discussed Between Parent and Child

时间窗: 6 months

Measured using the Parent-Child Communication Scale (communication on sexual and HIV topics that the intervention covers) for both parent and child participants in pre- and post-assessments. This is a measurement of the number of sex and HIV topics discussed. 16 topics were assessed, including how women get pregnant, how to use condoms to prevent pregnancy and HIV, and how to recognize sexual pressure. For each topic, participants answered yes or no if they discussed it, and then rate between 1-16 to indicate their communication (higher scores mean better communication). The total scores is reported as the sum of the 16 items, and can range from 0-16.

次要结局

未报告次要终点

研究者

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

Laura Bogart

Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital

Boston Children's Hospital

研究点 (2)

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