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临床试验/NCT02181647
NCT02181647已完成不适用

Safe Touches: A Rigorous Evaluation of a Sexual Abuse Prevention Program for Children

The New York Society for the Prevention of Cruelty to Children1 个研究点 分布在 1 个国家目标入组 492 人开始时间: 2012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
492
试验地点
1
主要终点
Children's Knowledge of Abuse Questionnaire

研究概览

简要总结

The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." The main study hypothesis is that children who receive the Safe Touches intervention will show greater improvement on their knowledge of inappropriate touches compared to children who do not receive the intervention.

详细描述

This study will conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." Founded in 2007, Safe Touches was developed for kindergarteners through third graders, and is conducted in the New York City public school system. The main goal of Safe Touches is to empower children to have personal agency over their bodies thus decreasing the likelihood of being inappropriately sexually touched and increasing the likelihood of disclosure if sexual abuse occurs.

While prior research provides some data regarding the efficacy of school-based child sexual abuse (CSA) prevention programs, evidence is profoundly marginal. First, most studies were not designed for multicultural populations, and therefore cannot inform what is effective in populations as diverse as New York City. A review of 22 studies evaluating school-based CSA prevention programs found just eight studies that used ethnically diverse samples, only one of which used a randomly assigned concurrent control group--however, this study had a very small sample size. Further, only three of the studies explored the mediating effects of factors such as gender and ethnicity on outcomes. The authors of those studies recommend future research that includes diverse samples and investigates differences in child characteristics more systematically--these recommendations are incorporated into the design and analysis plan of the current study. Second, statistical methods applied to data from prior studies were limited. A meta-analysis of 15 randomized controlled trials (RCTs) of school-based CSA prevention programs found that 10 studies used statistical analyses inappropriate for their particular design, thus increasing the risk for bias. Further, none of the 15 RCTs reported using the intention-to-treat principle. Third, no prior research has evaluated the cost of these programs relative to what children learn. In light of how common these programs are and the lack of valid evidence as to their efficacy, this study will determine their relative value with regard to acquisition of protective skills by addressing the first and second methodological gaps mentioned above, and expanding the scope to include the third, cost-effectiveness.

Study aims are:

  1. To determine the significance of the difference in effectiveness between the Intervention and Control groups with regard to changes in children's recognition of unsafe touches/situations/people and acquisition of self-protective skills (short-term retention).
  2. To evaluate maintenance of knowledge gains four weeks after intervention (maintenance).
  3. To assess intervention costs relative to short-term retention and maintenance four weeks after intervention.

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
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • second and third graders at participating New York City public schools
  • at least 7 years old
  • have not participated in Safe Touches program in the past

排除标准

  • physical, cognitive, or emotional impairment that would affect the child's ability or safety in participating in the workshop or to respond to the questionnaire.

结局指标

主要结局

Children's Knowledge of Abuse Questionnaire

时间窗: up to 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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