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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)
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 poten...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7374139/ https://www.ncbi.nlm.nih.gov/pubmed/32707101 http://dx.doi.org/10.1016/j.cct.2020.106088 |
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author | Berkel, Cady Smith, Justin D. Bruening, Meg M. Jordan, Neil Fu, Emily Mauricio, Anne M. Grimm, Kevin J. Winslow, Emily Ray, Kristen Bourne, Annette Dishion, Thomas J. |
author_facet | Berkel, Cady Smith, Justin D. Bruening, Meg M. Jordan, Neil Fu, Emily Mauricio, Anne M. Grimm, Kevin J. Winslow, Emily Ray, Kristen Bourne, Annette Dishion, Thomas J. |
author_sort | Berkel, Cady |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7374139 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-73741392020-07-22 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) Berkel, Cady Smith, Justin D. Bruening, Meg M. Jordan, Neil Fu, Emily Mauricio, Anne M. Grimm, Kevin J. Winslow, Emily Ray, Kristen Bourne, Annette Dishion, Thomas J. Contemp Clin Trials Article 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. Elsevier Inc. 2020-09 2020-07-22 /pmc/articles/PMC7374139/ /pubmed/32707101 http://dx.doi.org/10.1016/j.cct.2020.106088 Text en © 2020 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Berkel, Cady Smith, Justin D. Bruening, Meg M. Jordan, Neil Fu, Emily Mauricio, Anne M. Grimm, Kevin J. Winslow, Emily Ray, Kristen Bourne, Annette Dishion, Thomas J. 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) |
title | 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) |
title_full | 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) |
title_fullStr | 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) |
title_full_unstemmed | 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) |
title_short | 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) |
title_sort | 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) |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7374139/ https://www.ncbi.nlm.nih.gov/pubmed/32707101 http://dx.doi.org/10.1016/j.cct.2020.106088 |
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