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

NCT ID: NCT06853483

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-03
• Study Completion Date: 2026-06-01

Brief Summary

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type: EXPERIMENTAL

Family-School based smoking cessation intervention package

Intervention Type: BEHAVIORAL

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 strategies, using formats such as online videos and supplemental materials, with interventions designed to help students and parents of smokers to understand the health hazards of smoking, to enhance cessation action and supportive skills, and inspire healthy action.

Interventions

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 strategies, using formats such as online videos and supplemental materials, with interventions designed to help students and parents of smokers to understand the health hazards of smoking, to enhance cessation action and supportive skills, and inspire healthy action.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Gong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dongxihu Primary School

Wuhan, Hubei, China

Countries

China

Other Identifiers

S133

Identifier Type: -

Identifier Source: org_study_id