TY - JOUR
T1 - The Family Check-Up 4 Health
T2 - Study protocol of a randomized type II hybrid effectiveness–implementation trial in integrated primary care (the healthy communities 4 healthy students study)
AU - Berkel, Cady
AU - Smith, Justin D.
AU - Bruening, Meg M.
AU - Jordan, Neil
AU - Fu, Emily
AU - Mauricio, Anne M.
AU - Grimm, Kevin J.
AU - Winslow, Emily
AU - Ray, Kristen
AU - Bourne, Annette
AU - Dishion, Thomas J.
N1 - Funding Information:
The Healthy Communities 4 Healthy Students project of the FCU4Health program received support from the National Institute of Food and Agriculture (NIFA), Agriculture and Food Research Initiative (AFRI)’s Childhood Obesity Prevention Challenge Area. The stated aim of this Challenge Area is to end child obesity in the U.S. In previous years, this challenge sought to target early (FY 2011) and mid-to-late (FY 2012) adolescence, in alignment with the developmental periods experiencing the highest rates of childhood obesity. In FY 2016, the target age range was expanded down to two years to reflect data suggesting that early prevention is focused on addressing health behaviors, particularly for children at risk for health disparities, is more effective than later treatment.This study is supported by a Childhood Obesity Challenge Area grant (2018-68001-27550) from the Agriculture and Food Research Initiative (AFRI) of the National Institute of Food and Agriculture (NIFA) at the United States Department of Agriculture, awarded to Cady Berkel and Justin D. Smith, and by funding from the First Things First Southwest Maricopa Regional Council (ISA-RC007-19-0992-01) awarded to Cady Berkel. Additional support was provided by grant U18 DP006255 from the National Center for Chronic Disease Prevention and Health Promotion of the Centers of Disease Control and Prevention, under the Childhood Obesity Research Demonstration Project 2.0 (CORD), awarded to Cady Berkel and Justin D. Smith. Additional support was provided by grant DA027828 from the National Institute on Drug Abuse, awarded to C. Hendricks Brown, and by the Implementation Research Institute (IRI) at the George Warren Brown School of Social Work, Washington University in St. Louis through grant R25 MH080916 from the National Institute of Mental Health and the Department of Veterans Affairs, Health Services Research & Development Service, Quality Enhancement Research Initiative (QUERI). The opinions expressed herein are the views of the authors and do not necessarily reflect the official policy or position of the United States Department of Agriculture, First Things First, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the National Institute on Drug Abuse, the National Institute of Mental Health, or any other part of the US Department of Health and Human Services. Development work for this project was supported by a research grant from the College of Liberal Arts and Sciences at Arizona State University, awarded to Thomas Dishion. The trial is registered at clinicaltrials.gov under NCT04469816.
Funding Information:
This study is supported by a Childhood Obesity Challenge Area grant ( 2018-68001-27550 ) from the Agriculture and Food Research Initiative (AFRI) of the National Institute of Food and Agriculture (NIFA) at the United States Department of Agriculture , awarded to Cady Berkel and Justin D. Smith, and by funding from the First Things First Southwest Maricopa Regional Council ( ISA-RC007-19-0992-01 ) awarded to Cady Berkel. Additional support was provided by grant U18 DP006255 from the National Center for Chronic Disease Prevention and Health Promotion of the Centers of Disease Control and Prevention , under the Childhood Obesity Research Demonstration Project 2.0 (CORD), awarded to Cady Berkel and Justin D. Smith. Additional support was provided by grant DA027828 from the National Institute on Drug Abuse , awarded to C. Hendricks Brown, and by the Implementation Research Institute (IRI) at the George Warren Brown School of Social Work, Washington University in St. Louis through grant R25 MH080916 from the National Institute of Mental Health and the Department of Veterans Affairs, Health Services Research & Development Service, Quality Enhancement Research Initiative (QUERI). The opinions expressed herein are the views of the authors and do not necessarily reflect the official policy or position of the United States Department of Agriculture, First Things First, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the National Institute on Drug Abuse, the National Institute of Mental Health, or any other part of the US Department of Health and Human Services. Development work for this project was supported by a research grant from the College of Liberal Arts and Sciences at Arizona State University , awarded to Thomas Dishion. The trial is registered at clinicaltrials.gov under NCT04469816.
Funding Information:
The Healthy Communities 4 Healthy Students project of the FCU4Health program received support from the National Institute of Food and Agriculture (NIFA), Agriculture and Food Research Initiative (AFRI)’s Childhood Obesity Prevention Challenge Area. The stated aim of this Challenge Area is to end child obesity in the U.S. In previous years, this challenge sought to target early (FY 2011) and mid-to-late (FY 2012) adolescence, in alignment with the developmental periods experiencing the highest rates of childhood obesity. In FY 2016, the target age range was expanded down to two years to reflect data suggesting that early prevention is focused on addressing health behaviors, particularly for children at risk for health disparities, is more effective than later treatment.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/9
Y1 - 2020/9
N2 - Background: 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. 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.
AB - Background: 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. 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.
KW - Family Check-Up 4 Health
KW - Family-based prevention
KW - Hybrid design
KW - Integrated behavioral health
KW - Primary care
KW - Study protocol
UR - http://www.scopus.com/inward/record.url?scp=85088655974&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85088655974&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.106088
DO - 10.1016/j.cct.2020.106088
M3 - Article
C2 - 32707101
AN - SCOPUS:85088655974
SN - 1551-7144
VL - 96
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106088
ER -