School of Public Health, Georgia State University, Atlanta, GA, USA.
School of Public Health, Emory University, Atlanta, GA, USA.
Trials. 2024 Oct 7;25(1):661. doi: 10.1186/s13063-024-08466-2.
Secondhand smoke exposure (SHS) and child maltreatment (CM) are preventable yet have negative lifelong impacts on health. When considered together, the risk for negative health outcomes may be compounded, especially for people living in low-resource settings. Evidence-based interventions exist for preventing CM and reducing SHS among families with low resources; however, no programs jointly target SHS exposure and maltreatment risk.
This study is a hybrid type 1 trial to examine the effectiveness of a systematically braided intervention to target CM risk and SHS in the home. Fifty SafeCare Providers will be randomized to deliver either standard SafeCare (i.e., the SafeCare model alone; active treatment control; n = 25) or Smoke-Free Home SafeCare (SFHSC; treatment condition; n = 25), the braided intervention that includes both SafeCare and the Smoke-Free Homes: Some Things are Better Outside intervention to N = 500 families. Aim 2 is to assess family-level outcomes. The primary outcome is a full home smoking ban, validated by air nicotine monitors; secondary outcomes include parenting and smoking outcomes. Aim 3 is to evaluate process and implementation outcomes, including cost-benefit. We will use multilevel models and ROC analyses to evaluate and validate the primary outcome. We will use tests of non-inferiority to evaluate secondary outcomes. Cost-effectiveness analyses will be used to assess cost-benefit of SFHSC.
This study will be the first to document the outcomes of a multi-component intervention to address cumulative risk factors that impact cancer risk among children whose parents are at risk or involved in child-protective services. Integrating an evidence-based intervention that targets SHS exposure in the home with a broadly disseminated CM prevention intervention may be a sustainable way to help reduce the compounded effects of SHS in the home and CM.
Clinicaltrials.gov, NCT05000632. Registered on August 11, 2021.
二手烟暴露（SHS）和儿童虐待（CM）是可以预防的，但它们会对健康造成终身负面影响。当两者同时考虑时，负面健康结果的风险可能会加剧，尤其是对于生活在资源匮乏环境中的人。已经有针对资源匮乏家庭的 CM 预防和减少 SHS 的循证干预措施；然而，没有针对 SHS 暴露和虐待风险的联合项目。
本研究是一种混合型 1 期试验，旨在检验针对家庭中 CM 风险和 SHS 的系统编织干预措施的有效性。50 名安全护理提供者将被随机分配到标准安全护理组（即安全护理模式单独；主动治疗对照组；n=25）或无烟家庭安全护理组（治疗组；n=25），该编织干预措施包括安全护理和无烟家庭：有些东西在外面更好干预措施，共涉及 500 个家庭。目标 2 是评估家庭层面的结果。主要结果是通过空气尼古丁监测器验证的全面家庭禁烟；次要结果包括育儿和吸烟结果。目标 3 是评估过程和实施结果，包括成本效益。我们将使用多层模型和 ROC 分析来评估和验证主要结果。我们将使用非劣效性检验来评估次要结果。成本效益分析将用于评估无烟家庭安全护理的成本效益。
本研究将首次记录一种多成分干预措施的结果，该措施旨在解决影响父母处于风险中或参与儿童保护服务的儿童癌症风险的累积风险因素。将针对家庭中 SHS 暴露的循证干预措施与广泛传播的 CM 预防干预措施相结合，可能是一种可持续的方法，有助于减少家庭中 SHS 和 CM 的复合效应。
Clinicaltrials.gov，NCT05000632。于 2021 年 8 月 11 日注册。
