Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial.
Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial.
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DOI：
10.1136/bmjopen-2015-008749
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发表时间：
2015-08-25
期刊：
影响因子：
2.9
通讯作者：
Sheikh A
中科院分区：
文献类型：
--
作者：
Siddiqi K;Huque R;Jackson C;Parrott S;Dogar O;Shah S;Thomson H;Sheikh A
暴露于二手烟（SHS）会增加儿童患胸部和耳部感染、结核病、脑膜炎和哮喘的风险。公共场所禁烟令（在实施的情况下）大大减少了成年人对二手烟的暴露。然而，对于儿童来说，家庭仍然是他们最可能接触到SHS的地方。因此，需要采取额外的措施来保护儿童免受性暴力的伤害。在孟加拉国达卡的一项可行性研究中，我们已经证明，以学校为基础的无烟干预（SFI）在鼓励儿童在家中协商和实施吸烟限制方面取得了成功。我们现在将进行一项试点试验，为开展一项随机对照试验（RCT）的计划提供信息，以调查SFI在减少儿童接触SHS方面的有效性和成本效益。我们计划在孟加拉国达卡招募12所小学。从这些学校中，我们将招收大约360名五年级（10-12岁）的学生，即每所学校30名。SFI包括六项互动教育活动，旨在提高学生对二手烟和相关危害的认识，激励他们采取行动，提供与成年人谈判的技能，说服他们不要在家里吸烟，并帮助家庭“签署”自愿合同，使他们的家庭无烟。控制组的孩子将接受常规教育。我们将评估：招募和流失率、可接受性、对SFI的保真度、效应大小、集群内相关系数、干预成本和不良事件。我们的主要结果将包括通过唾液可替宁测量儿童的SHS暴露。次要结果将包括呼吸道症状、肺功能检查、保健接触、上学情况、吸烟情况、生活质量和学习成绩。该试验已获得约克大学研究管理委员会的伦理批准。研究结果将帮助我们制定最终试验计划。ISRCTN68690577。
Exposure to secondhand smoke (SHS) increases children’s risk of acquiring chest and ear infections, tuberculosis, meningitis and asthma. Smoking bans in public places (where implemented) have significantly reduced adults’ exposure to SHS. However, for children, homes remain the most likely place for them to be exposed to SHS. Additional measures are therefore required to protect children from SHS. In a feasibility study in Dhaka, Bangladesh, we have shown that a school-based smoke-free intervention (SFI) was successful in encouraging children to negotiate and implement smoking restrictions in homes. We will now conduct a pilot trial to inform plans to undertake a cluster randomised controlled trial (RCT) investigating the effectiveness and cost-effectiveness of SFI in reducing children’s exposure to SHS. We plan to recruit 12 primary schools in Dhaka, Bangladesh. From these schools, we will recruit approximately 360 schoolchildren in year 5 (10–12 years old), that is, 30 per school. SFI consists of six interactive educational activities aimed at increasing pupils’ knowledge about SHS and related harms, motivating them to act, providing skills to negotiate with adults to persuade them not to smoke inside homes and helping families to ‘sign-up’ to a voluntary contract to make their homes smoke-free. Children in the control arm will receive the usual education. We will estimate: recruitment and attrition rates, acceptability, fidelity to SFI, effect size, intracluster correlation coefficient, cost of intervention and adverse events. Our primary outcome will consist of SHS exposure in children measured by salivary cotinine. Secondary outcomes will include respiratory symptoms, lung function tests, healthcare contacts, school attendance, smoking uptake, quality of life and academic performance. The trial has received ethics approval from the Research Governance Committee at the University of York. Findings will help us plan for the definitive trial. ISRCTN68690577.