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临床试验/NCT06111651
NCT06111651已完成不适用

Family-Based Prevention to Promote the Social-Emotional Functioning and Healthy Lifestyle Behaviors of Black & Latinx Children

University of South Carolina2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月5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
80
试验地点
2
主要终点
child physical activity

研究概览

简要总结

The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.

详细描述

This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery.

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 (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Eligible children will:
  • be between the ages of 3-6 years
  • identify as Black/African American or Latinx/Hispanic
  • have a parent or caregiver willing to participate in the intervention that: (a) lives in the same household as the child ≥50% of the time, (b) has primary responsibility for the child, and (c) speaks English or Spanish.

排除标准

  • Consistent with typical methods associated with a universal prevention approach, there are minimal exclusion criteria. Children will be excluded who:
  • have a cognitive/psychological condition that limits the child's ability to communicate
  • have a physical health condition that limits the child's ability to be physically active

结局指标

主要结局

child physical activity

时间窗: pre (weeks 0-2) and post intervention (weeks 6-8)

Time spent sedentary and in light, moderate, and vigorous physical activity each day will be collected using a waterproof accelerometer. Validated methods will be used to identify valid days and derive activity intensities.

child social-emotional functioning

时间窗: pre (weeks 0-2) and post intervention (weeks 6-8)

Parent-reported assessment of various positive and negative child behaviors. Likert scale values range from 0 to 2, with higher values typically indicating greater dysfunctional behavior.

child sleep

时间窗: pre (weeks 0-2) and post intervention (weeks 6-8)

Child average nightly sleep duration and quality will be calculated from data obtained using a waterproof accelerometer.

次要结局

  • parenting practices(pre (weeks 0-2) and post intervention (weeks 6-8))
  • ethnic-racial socialization practices(pre (weeks 0-2) and post intervention (weeks 6-8))

研究者

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

Daniel Cooper

Assistant Professor

University of South Carolina

研究点 (2)

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