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

Huazhong University of Science and Technology

Status: Invitation-only

Conditions: Smoking Cessation

Treatments: Behavioral: Family-School based smoking cessation intervention package

Study type: Interventional

Funder types: Other

Identifiers

NCT06853483

S133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Primary 4 students and their smoking parents.
2. The student has a parent who is a smoker (a smoker is defined as smoking at least 1 cigarette per day).
3. The student and participating parent reside together on a long-term basis.
4. 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Control group

No Intervention group

Description:

Students in control group will have regular health education classes . Parents in control group will not receive any intervention other than completion questionnaires and cotinine testing.

Intervention group

Experimental group

Description:

Students and parents of smokers in the intervention group will work together to receive home-school based smoking cessation intervention strategies.

Treatment:

Behavioral: Family-School based smoking cessation intervention package