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临床试验/NCT00060697
NCT00060697Unknown2 期

Family Intervention to Promote Health in Children

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2000年12月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
1,300
试验地点
2

研究概览

简要总结

The goal of this study is to enhance the mother's role in promoting avoidance of sexual risks and problem behaviors in 6- to 12-year-old children. Consenting mothers will attend a 10-session program designed to enhance the quality of mother-child communication, identify sexual risks, and increase parental monitoring and self-efficacy.

详细描述

This study will identify personal, parental, peer, and community factors that predispose children ages 6 to 12 to early initiation of sexual behavior or that foster resilience to sexual risk taking. The study will then evaluate an intervention designed to enhance resilience factors and reduce risk factors among 6- to 12-year-old children. The study will focus on the mother's role in promoting resilience to sexual risk taking.

During the first phase of the study, 300 children and their mothers will be asked to complete a one-time interview that includes an assessment of risk and resilience factors. Information from the interviews will be used to modify an intervention currently being used in another study of parent-adolescent pairs. The modified intervention will then be tested to determine the efficacy of the intervention in reducing risk and enhancing resilience among children in this age group.

In the second phase of the study, 296 children and their mothers will be randomized to either the intervention or control group. All mothers will complete a baseline interview. Mothers in the intervention group will attend 10 group sessions that include short presentations, discussions, media presentations (videotapes), and interactive exercises, including self-assessments, role plays, and games. The group sessions include content and skill development related to parenting, communication, sexuality, peer pressure, and school involvement. Mothers in the control group receive written information on diet and physical activity. The written materials are presented in a self-help format to increase physical activity; a cookbook contains low fat recipes designed especially for African American men and women living in the Atlanta, GA, area.

All participants complete follow-up interviews at 6 and 12 months after the baseline interview. Primary outcomes for mothers include measures of resilience and communication related to sexual issues. For children, outcomes include measures related to possible sexual situations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single

入排标准

年龄范围
6 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Member of a participating community-based organization
  • Child 6 to 12 years of age and biological mother/legal guardian
  • Ability to read and comprehend English
  • Willing to participate

排除标准

  • 未提供

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (2)

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