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.
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。