REACH Institute, Arizona State University, Tempe, AZ, USA; Phoenix Children's Hospital, Phoenix, AZ, USA.
Center for Prevention Implementation Methodology (Ce-PIM), Department of Psychiatry and Behavioral Sciences, Department of Preventive Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Contemp Clin Trials. 2020 Sep;96:106088. doi: 10.1016/j.cct.2020.106088. Epub 2020 Jul 22.
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.
养育干预措施，如家庭检查，已证明对儿童身体和行为健康结果有影响。然而，这些项目的可及性有限，尤其是对于那些存在健康差异的人群。初级保健机构已被认为是一种潜在的提供系统，可以在其中大规模实施这些项目。本试验的目的是测试家庭检查 4 健康（FCU4Health）计划的有效性，该计划是 FCU 的一种适应形式，用于初级保健，并评估在综合初级保健环境中的实施情况。
我们将与一个低收入、以拉丁裔为主的社区的初级保健诊所合作，开展一项混合 2 型有效性-实施试验。有 2 至 5 岁儿童的家庭有资格参加。家庭将被随机分配接受干预（n=130）或常规服务（n=70），并在三年内每年进行评估。结果由 RE-AIM 框架（即，覆盖范围、效果、采用、实施和维持）告知。有效性结果包括儿童健康行为（例如，饮食筛选问卷）、行为健康（例如，优势和困难问卷）和养育（例如，积极养育）。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。实施结果主要是描述性的，并与 FCU4Health 和原始 FCU 的先前试验进行比较。
本试验将提供有关综合初级保健环境提供具有行为和身体健康双重重点的循证预防干预措施的潜力的证据。
