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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

China · 1 center

• Dongxihu Primary School — Wuhan

Identifiers

NCT: NCT06853483 · S133

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗