School-EduSmoke: A Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren

Обзор

This study is a pragmatic two-group, multi-center, randomized controlled superiority trial, including an internal pilot, economic evaluation and process evaluation, aiming to assess the impact of a school-based comprehensive intervention on smoking cessation actions among parents who smoke.

Подробное описание

The School-EduSmoke project will be based on the Behavior change wheel (BCW) and theoretical domain framework. The goal of our project is to promote smoking cessation actions by parents through smoking cessation education for children and their parents in schools. The programme will enhance the implementation of smoking cessation behaviours by identifying key risk factors that influence smoking behaviour, helping to design specific interventions that will particularly help to address ambivalence and defensiveness among smokers. A set of randomized controlled trials will be used to evaluate the effectiveness of the intervention. The findings will provide evidence and support for the provision of low-cost, low-resource, widely accessible smoking cessation support to the smoking community, thereby promoting the effective implementation of smoke-free health actions.

Вмешательства

• Поведенческое Family-School based smoking cessation intervention package
  The Family-School based smoking cessation intervention programme will be developed using the multiple strategies provided by the BCW framework, with face-to-face + online as the primary mode of implementation. Specifically, educational training based on the school curriculum will be conducted to create a supportive environment for smokers to quit, guide smokers to discover motivation to quit, encourage smokers to cope with key barriers to quitting, as well as incorporate relapse prevention strat

Первичные конечные точки

• Biochemically validated 24-hour point smoking cessation rate at 6 month [Срок оценки: 6-month followup]

Вторичные конечные точки (3)

• Self-reported 7-day point prevalence quit rate [Срок оценки: 6 month follow-up]
• 50% reduction in the number of cigarettes smoked [Срок оценки: 6-month follow-up]
• The level of readiness to quit [Срок оценки: 1-month and 6-month follow-up]

Критерии участия

Критерии включения

• Primary 4 students and their smoking parents.
• The student has a parent who is a smoker (a smoker is defined as smoking at least 1 cigarette per day).
• The student and participating parent reside together on a long-term basis.
• The student and parents have the cognitive, understanding and communication skills to voluntarily participate in this project.

Критерии исключения

• 1\) The parent who smokes is currently using other tobacco substances, has recently participated in nicotine replacement therapy, or has other substance abuse.

2\) The parent or student has a serious organic or somatic disease. 3) The parent or student is unwilling to cooperate with the test or refuses to answer questions.

4\) The parent or student has a serious illness that is life-threatening or requires regular hospitalisation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Dongxihu Primary School — Ухань

Идентификаторы

NCT: NCT06853483 · S133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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