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

NCT06853483 | Enrolling By Invitation DMC

• 1 other identifier: S133
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Biochemically validated 24-hour point smoking cessation rate at 6 month

  Assessing smoking cessation in parents by measuring their urine cotinine levels

  6-month followup

Secondary Outcomes (3)

• Self-reported 7-day point prevalence quit rate

  6 month follow-up

• 50% reduction in the number of cigarettes smoked

  6-month follow-up

• The level of readiness to quit

  1-month and 6-month follow-up

Study Arms (2)

Control group

NO INTERVENTION

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

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

Behavioral: Family-School based smoking cessation intervention package

Interventions

Family-School based smoking cessation intervention package 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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) The parent who smokes is currently using other tobacco substances, has recently participated in nicotine replacement therapy, or has other substance abuse.
• \) 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.
• \) The parent or student has a serious illness that is life-threatening or requires regular hospitalisation.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Dongxihu Primary School

Wuhan, Hubei, 453000, China

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 3, 2025
• Study Start: May 3, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)