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Abstract：
Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.
We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.
摘要：
像家庭检查这样的育儿干预措施已经证明了对儿童身体和行为健康结果的影响。然而,对这些程序的访问是有限的，特别是对于经历健康差异的人群。初级保健设置已被认为是一种潜在的交付系统，可以在其中大规模实施这些程序。本试验的目的是测试家庭体检4健康（FCU4Health）计划的有效性，FCU对初级保健的改编，并评估综合初级保健环境中的项目实施情况。
我们将与低收入家庭的初级保健诊所合作进行混合2型有效性实施试验，多数拉丁裔社区。有2至5岁儿童的家庭将有资格参加。家庭将被随机分配接受干预（n=130）或照常接受服务（n=70），并将在三年内每年进行评估。结果由RE-AIM框架提供信息(即，reach,有效性,收养,实施，和维护)。有效性结果包括儿童健康行为(例如，膳食筛选问卷)，行为健康(例如，优势和困难问卷)，和育儿(例如，积极的育儿）。还包括早期实施结果(例如，成本,可接受性,适当性，和可行性)。有效性结果将通过意向治疗（ITT）分析进行评估。实施结果将主要是描述性的，与FCU4Health和原始FCU的先前试验进行比较。
该试验将提供与综合初级保健机构的潜力相关的证据，以提供基于证据的预防性干预措施，同时关注行为和身体健康。
我们将与低收入家庭的初级保健诊所合作进行混合2型有效性实施试验，多数拉丁裔社区。有2至5岁儿童的家庭将有资格参加。家庭将被随机分配接受干预（n=130）或照常接受服务（n=70），并将在三年内每年进行评估。结果由RE-AIM框架提供信息(即，reach,有效性,收养,实施，和维护)。有效性结果包括儿童健康行为(例如，膳食筛选问卷)，行为健康(例如，优势和困难问卷)，和育儿(例如，积极的育儿）。还包括早期实施结果(例如，成本,可接受性,适当性，和可行性)。有效性结果将通过意向治疗（ITT）分析进行评估。实施结果将主要是描述性的，与FCU4Health和原始FCU的先前试验进行比较。
该试验将提供与综合初级保健机构的潜力相关的证据，以提供基于证据的预防性干预措施，同时关注行为和身体健康。
