The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness–implementation trial in integrated primary care (the healthy communities 4 healthy students study)

Abstract

Background: Parenting interventions like the Family CheckUp 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 CheckUp 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting. Methods: 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. Projected outcomes: 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.

A machine learning approach to improve implementation monitoring of family-based preventive interventions in primary care

“…These challenges are more easily overcome by human transcription than machine transcription. In a current trial, FCU4Health sessions have moved entirely online to telehealth delivery (via zoom) due to the COVID-19 pandemic mitigation measures ( Berkel, Smith, et al, 2020 ). We expect that this will result in better audio quality than the in-person meetings and facilitate coding directly from the audio.…”

A cluster randomised effectiveness-implementation trial of an intervention to increase the adoption of PAX Good Behaviour Game, a mental health prevention program, in Australian primary schools: Study protocol

“…In light of the literature, strategies that facilitate this knowledge translation will lead to better outcomes for children and young people [ 31 , 59 ]. More broadly, this protocol provides learning about how to conduct hybrid effectiveness-implementation trials, which are an emerging area of research as evidenced by the numerous hybrid trial protocols published between 2019 and 2021 [ [60] , [61] , [62] , [63] , [64] , [65] , [66] , [67] , [68] , [69] ].…”

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness‐implementation trial

“…However, these samples did not specifically target children with elevated BMI. A longer follow‐up is occurring in an ongoing study of the program with families and children ages 2 to 5 years (at study entry) with sociodemographic risk for obesity, which will intervene and follow families over a 3‐year period 55 . In addition to variable intervention dose and follow‐up time horizon considerations already mentioned, the FCU4Health was primarily delivered by coordinators hired specifically for the study.…”

“…A longer follow-up is occurring in an ongoing study of the program with families and children ages 2 to 5 years (at study entry) with sociodemographic risk for obesity, which will intervene and follow families over a 3-year period. 55 In addition to variable intervention dose and follow-up time horizon considerations already mentioned,…”