Study protocol for a randomized controlled trial of Adapt 2 Asthma (A2A), a culturally relevant coping skills and asthma management intervention for Latinx Families.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-10-22 DOI:10.1186/s13063-024-08531-w
Erin M Rodríguez, Spencer Westcott, María Paula Yávar Calderón, Sharon D Horner, Elizabeth C Matsui, Jendayi Dillard, Hadi Fareed, Jennifer Camacho
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Abstract

Background: Latinx children in the United States experience disparities in asthma control and asthma-related functional outcomes compared to non-Latinx White children, including more school absences, emergency department visits, and hospitalizations for asthma. Stress appears to play a role in asthma control, but interventions designed to address the role of stress in asthma control for Latinx children are limited.

Method: The current randomized controlled trial tests the effects of Adapt 2 Asthma (A2A), a family-based coping skills and asthma management intervention tailored to the stressors, strengths, and cultural beliefs of Latinx families, compared to an asthma self-management control arm (the Asthma Plan for Kids; APK). Latinx families of children ages 8 to 14 years old with asthma (target N = 280) are identified and enrolled from primary care clinics and randomly assigned to either A2A or APK. The intervention is delivered by lay health workers trained and receiving ongoing consultation from the study team. The primary outcome is child- and parent-reported asthma control, while secondary outcomes are child's quality of life, lung function, school absences, and emergency department visits, and child and parent coping and family asthma management behaviors. Participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up timepoints.

Discussion: This study has the potential to provide new evidence regarding the effects of culturally relevant coping and asthma management intervention strategies for Latinx children with asthma.

Trial registration: Clinicaltrials.gov NCT05118282 . Registered on 11 November 2021.

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适应 2 哮喘(A2A)随机对照试验研究方案,这是一项针对拉丁裔家庭的文化相关应对技能和哮喘管理干预措施。
背景:与非拉美裔白人儿童相比,美国拉美裔儿童在哮喘控制和哮喘相关功能结果方面存在差异,包括缺课、急诊就诊和因哮喘住院的情况更多。压力似乎在哮喘控制中起着一定的作用,但针对压力在拉美裔儿童哮喘控制中的作用而设计的干预措施却很有限:目前的随机对照试验测试了 "适应 2 哮喘"(A2A)与哮喘自我管理对照组("儿童哮喘计划";APK)的效果对比。"适应 2 哮喘 "是一项基于家庭的应对技能和哮喘管理干预措施,针对拉美裔家庭的压力、优势和文化信仰而量身定制。有 8-14 岁哮喘患儿的拉美裔家庭(目标人数 = 280)从初级保健诊所中确定并注册,然后随机分配到 A2A 或 APK。干预措施由经过培训并接受研究小组持续咨询的非专业卫生工作者实施。主要结果是儿童和家长报告的哮喘控制情况,次要结果是儿童的生活质量、肺功能、缺课率、急诊就诊率,以及儿童和家长的应对和家庭哮喘管理行为。参与者将在基线、干预后、6 个月和 12 个月的随访时间点接受评估:讨论:这项研究有可能为拉丁裔哮喘儿童提供有关文化相关的应对和哮喘管理干预策略效果的新证据:试验注册:Clinicaltrials.gov NCT05118282。注册日期:2021 年 11 月 11 日。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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